Biktarvy Continues to Suppress HIV Well in Long-Term Follow-Up

This held true even among those with resistance to nucleoside/nucleotide reverse transcriptase inhibitors.

This article is from Poz.com writer Benjamin Ryan

Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) boasts high rates of viral suppression even after two years of treatment and is also highly effective among those who start the regimen with resistance to the nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) class of ARVs.

Biktarvy was approved in February 2018 in the US and is indicated for those starting their first HIV treatment regimen as well as those switching from a previous antiretroviral (ARV) regimen who have been virally suppressed for at least three months on that regimen. Those switching to Biktarvy should have no history of treatment failure and no known viral mutations that confer resistance to integrase inhbitors. (The bictegravir component of Biktarvy falls into that class of ARVs.)

Researchers presented a trio of studies at the 2019 Conference on Retroviruses and Opportunistic Infections in Seattle concerning Biktarvy’s long-term efficacy and its efficacy in the face of drug-resistant HIV.  

Studies 1844 and 1878 included people with HIV who were treated with Biktarvy for 96 weeks. Among the 570 people who switched from Triumeq (dolutegravir/abacavir/lamivudine) or a protease inhibitor–based regimen to Biktarvy, 155 (98 percent) were virally suppressed at the 96-week mark. Among the subset of 159 members of this group who started the study with drug-resistant virus, 155 (97 percent) had a fully suppressed virus after 96 weeks, including 42 of 44 (95 percent) who had the M184V/I resistance mutation, which is associated with resistance to the NRTIs lamivudine and emtricitabine, the latter of which is included in Biktarvy.

None of the participants developed resistance to the drugs included in Biktarvy during the study.

Study 4030, also presented at the conference, included 565 people with fully suppressed HIV who were evenly randomized to switch to Biktarvy from a regimen of Tivicay (dolutegravir) plus either Descovy (emtricitabine/tenofovir alafenamide) or Truvada (tenofovir disoproxil fumarate/emtricitabine). The study permitted enrollment to any participants who had virus resistant to NRTIs, non-nucleoside reverse transcriptase inhibitors or protease inhibitors. Those with resistance to integrase inhibitors were excluded.

A total of 138 (24 percent) of the participants had NRTI resistance at the study’s outset.

Of the 562 people who made any of the study’s follow-up visits, 557 (99 percent) had a fully suppressed viral load, as did 220 of 222 (99 percent) of those with any ARV resistance, including 79 of 81 (98 percent) of those with the M184V/I resistance mutation. No participant has developed new drug resistance so far in this ongoing trial.

Detectable HIV Despite Treatment? Clonal Expansion Could Be The Culprit

In a study of people with a low but detectable viral load despite adherence to treatment, infected cells were apparently cloning themselves.

This article comes from Poz.com and was originally posted on March 12, 2019 and was written by Benjamin Ryan

People who maintain a low but detectable viral load despite adhering well to antiretroviral (ARV) treatment may in some cases have latently HIV-infected immune cells that clone themselves.

A latently infected immune cell is not replicating, meaning it stays under the radar of ARV treatment, which works only on cells that are actively churning out new virus.

Presenting their findings at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, researchers studied 10 people with HIV who had been on ARVs for a median of 10 years and had a median viral load of 97.5, with viral loads ranging between 40 and 356.

Generally, an individual viral load is considered undetectable if it is below 50, although the major studies that have supported the consensus that fully suppressing HIV prevents transmission used 200 or 400 as the viral load cutoff for undetectability. That said, some researchers have hypothesized that even viral loads as high as 1,000 or 1,500 might not be associated with a significant risk of transmission.

The researchers conducted genetic analyses of peripheral blood mononuclear cells drawn from the participants, including the sequencing of HIV RNA in the plasma and of HIV DNA integrated into cells’ genomes. (HIV carries its genetic material in the form of single-stranded RNA and then transcribes it into double-stranded DNA when infecting a cell.) They also stimulated cells to prompt the production of new HIV particles.

One participant was eliminated from the analysis because of evidence that the virus was evolving and accumulating mutations associated with resistance to ARVs. As for the remaining nine study members, the genetics of their HIV RNA neither changed over time nor had resistance mutations. The genetic sequences of the HIV RNA of six of these individuals matched those seen in HIV DNA incorporated into cellular genomes, suggesting clonal expansion of infected cells.

This presumption was further supported by the finding that HIV DNA found in an array of cells from each individual was integrated into similar sites in the cells’ genomes.

The study authors suggest that clinicians consider that clonal expansion, which can be identified through genetic sequencing, may be the cause an a detectable viral load in an individual who is  adhering well to an ARV regimen. Consequently, switching to a different HIV treatment regimen may not lead to full suppression of the virus.

More research is needed to flesh out the mechanisms by which HIV-infected cells clone themselves.

National Women Living with HIV Day

Women and HIV

Originally from The Well Project and also featured on Thebody.com this is a great summary of that state of play for women with HIV around the world.

Table of Contents

A Look at the Numbers

More than 35 years have passed since the first diagnosis of AIDS (Acquired Immune Deficiency Syndrome) in the US. While there were a handful of women among the first cases, AIDS was thought to mostly affect gay men. However, as the years passed, women have emerged as another group hard hit by the HIV/AIDS epidemic. Globally, women living with HIV account for half of all people living with HIV, and in many countries, women living with HIV outnumber men living with HIV. Across the globe, transgender women (transwomen) are affected by HIV to a much greater degree than other groups. The proportion of transwomen living with HIV is estimated to be 49 times higher than the proportion of people living with HIV in the general adult population.

In the US

In 2016, almost one in five new HIV diagnosis in the US were among women. African-American women are especially affected. African-American adolescent and adult women made up only 13 percent of the US female population and accounted for more than six of every ten new HIV cases among women in 2016. Latinas made up 17 percent of the US female population and accounted for 16 percent of all new HIV cases among women. For African-American women, the rate of HIV diagnosis was 16 times that of white women in the US. For Latinas, it was more than three times that of white women.Advertisement

Though not often talked about, American Indian/Alaskan Native communities experience the third-highest HIV rate of any racial group in the US. And while Asian/Pacific Islander communities may not be as heavily impacted by HIV, cultural factors may leave women in these communities vulnerable to acquiring HIV or make it harder for them to connect to HIV care. For more information on these factors, see our fact sheet on HIV among US women of different races or ethnicities.

Between 2011 and 2015, the number of new HIV diagnoses among all women dropped 16 percent. Although African-American women and Latinas continue to be disproportionately affected by the epidemic, new HIV diagnoses have declined among women of color, as well.

HIV affects both younger and older women. In fact, the rate of HIV diagnoses in older women has been rising recently; in 2013, women aged 45 and older accounted for 37 percent of new HIV diagnoses – more than twice the proportion of women 13 to 24 years old (14 percent).

Globally

The World Health Organization (WHO) estimates that almost 18 million adults living with HIV in 2014 were women. Although women account for approximately half of all people living with HIV worldwide, the percentage of women who are living with HIV varies widely among countries. Estimates suggest that one in three people living with HIV in the United Kingdom are women; almost four out of ten people living with HIV in India are women; and almost six in ten people living with HIV in sub-Saharan Africa are women. The Joint United Nations Programme on HIV/AIDS (UNAIDS) reports that only 21 percent of teen girls (ages 15 to 19) worldwide know enough about HIV to help them stay HIV-negative.

Transgender women: Across the globe, transwomen are affected by HIV to a much greater degree than other groups. It is estimated that the proportion of transwomen living with HIV is 49 times higher than in the general adult population. This is true whether transwomen are living in low-, middle-, or high-resource countries. Worldwide, 19 out of 100 transwomen in a given population will be living with HIV. For more information, see our fact sheet on Transwomen Living with HIV.

Older women: The number of older women living with HIV has been rising, not only because the rate of older women who have newly acquired HIV has increased, but because more women living with HIV are living longer, healthier lives and are aging with HIV. Older women deal with two stigmas – that of living with HIV, a disease spread through sexual contact or drug use, and that of being older. As a result, many older women are first diagnosed with HIV at a later stage of infection, when their immune systems are quite weakened.

Transmission

Heterosexual sex (sex between a male and female) is the most common way of getting HIV (or mode of transmission) among women in the US. During heterosexual sex, HIV is passed almost twice as easily from men to women as from women to men. More than eight out of every ten women living with HIV in the US get the virus through sex with a man living with HIV. Heterosexual sex is also the main source of HIV transmission for women in many other countries in Africa, South America, and Western Europe.

Sharing HIV-contaminated syringes for injecting drugs is another common mode of transmission.

Is HIV Different for Men and Women?

Until recently, little research had been done on women and HIV. While many questions remain unanswered, available information shows that HIV affects men and women differently in some ways:

  • When women are first diagnosed, they tend to have lower viral loads (amount of HIV in the blood) compared to men who are newly diagnosed
  • Women generally have lower CD4 cell counts than men with similar viral loads
  • Women are most often diagnosed when pregnant, considering becoming pregnant, or hospitalized with acute (initial) illness
  • Women are more likely than men to develop bacterial pneumonia
  • Women have higher rates of herpes infection than men
  • Women get thrush (a yeast infection) in their throats more often than men
  • Men are eight times more likely than women to develop Kaposi’s sarcoma or KS (a cancer-like disease caused by a herpes virus)

Women tend to be diagnosed with HIV later in their disease than men and fewer women than men are getting HIV treatment. Women may delay getting medical care and treatment and choose not to disclose their HIV status for several reasons, including:

  • Limited access to health care due to lack of insurance and/or transportation
  • Unstable housing
  • Fear of violence in the home (domestic violence)
  • Other responsibilities, such as child care or caring for a sick family member
  • The stigma associated with HIV
  • Problems with substance abuse or addiction
  • Depression
  • Lack of financial resources and/or social support
  • Mistrust of health care providers and/or the medical system
  • Taking care of everyone but themselves and not putting themselves first

Numerous studies have shown that, if a person living with HIV is taking HIV drugs and their viral load has reached undetectable levels (not enough HIV in their bloodstream for a test to measure), that person cannot transmit HIV to a sexual partner who is HIV-negative. This is true for men as well as women, but there is still more research needed into how this exciting development affects women in particular – especially when it comes to breastfeeding children, or the often unfair power dynamics women experience in their relationships. For more information, please see our fact sheet Undetectable Equals Untransmittable: Building Hope and Ending HIV Stigma.

Treatment in Women Living with HIV: Effectiveness, Side Effects, and Drug Interactions

HIV treatment studies (clinical trials) have traditionally included very few of women. As a result, most information on the effectiveness and safety of HIV drugs comes from research done in men. This under-representation of women in studies is slowly beginning to change. For more information on how The Well Project is working to improve research for women living with HIV, please visit our page on the Women’s Research Initiative on HIV/AIDS.

Existing research has found little difference in the effectiveness of HIV treatment for women and men. Women living with HIV who begin treatment as recommended to do as well as men living with HIV. Although treatment seems to work as well in women as in men, the side effects may differ:

  • Rashes: Women living with HIV are more likely than men to experience skin rashes from HIV drugs.
  • Liver problems: Women are more likely to experience liver problems as a side effect of certain HIV drugs. In fact, women with a CD4 count above 250 are warned against starting a drug combination with Viramune (nevirapine) because of the risk of dangerous liver problems.
  • Body shape changes: Some studies have found that women living with HIV experience different types of body shape changes than men. Women may experience more fat gain in their breasts and waists.
  • Weak bones: It is known that women in general are at increased risk of developing osteoporosis (weak bones) after menopause, but studies have also shown that living with HIV increases a person’s risk of weaker bones. This means both men and women living with HIV are at higher risk of osteoporosis. However, the risk for bone weakness in women living with HIV is three times higher than it is for men living with HIV.

Differences in side effects between men and women may be due to interactions between HIV treatment and female hormones. They may also be the result of women’s smaller physical size. Standard doses of drugs are usually based on research in men.

Women living with HIV do need to be careful about drug interactions. Certain HIV drugs can affect the levels of other drugs in the body. For example, several HIV drugs can affect the levels of birth control pills and change how effective those pills are at preventing pregnancy.

It is important for women living with HIV to be treated by health care providers who have experience in treating women with HIV. Tell your health care provider about all your medical conditions and any medications you are taking. If you experience side effects from your HIV drugs, be sure to ask your health care provider for help.

Gynecological Issues in Women Living with HIV

Certain gynecological (GYN) conditions are more common, more serious, and/or more difficult to treat in women living with HIV than in HIV-negative women:

Although little conclusive research is available on HIV and menstruation (periods), many women living with HIV report abnormal menstrual periods. Some bleed much more than usual while others stop menstruating altogether.

Human papillomavirus (HPV) is a sexually transmitted infection that causes 99 percent of cervical cancer and can also cause genital warts. Women living with HIV are more likely to be infected with HPV than HIV-negative women. Women living with HIV are also less likely to clear, or get rid of HPV, than HIV-negative women. Women living with HIV, especially those with advanced HIV disease (lower CD4 counts), are more likely to develop dysplasia (abnormal cervical cells) as a result of HPV.

Dysplasia means abnormal cells on the cervix (the opening of the womb). It is often more severe and difficult to treat in women living with HIV than in HIV-negative women. Untreated dysplasia can lead to cervical cancer, a life-threatening illness.

It is important to find HPV early and get treatment to prevent health problems. Regular cervical screening tests are a good way to check for HPV. An abnormal cervical screening test can indicate inflammation, infection, dysplasia, or cancer in the cervix.

The US National Institutes of Health (NIH) guideline recommends that:

  • women living with HIV have a complete gynecological examination, including a cervical screening test (e.g., Pap test), when they are first diagnosed with HIV – within one year of starting to be sexually active, for women with other modes of transmission (such as acquiring HIV ar birth or through injection drug use)
  • if the initial test is normal, women living with HIV have another cervical screening test 12 months later
  • if three tests in a row are normal, then screening is recommended every three years
  • women with abnormal tests or dysplasia should receive further testing – the type of test will differ depending on the result.

For more information, see our fact sheet on Caring for a Woman’s Body: What Every Woman Should Know about the Care and Prevention of GYN Problems.

There are also three effective HPV vaccines. Since the introduction of the HPV vaccines in the US in 2006, the number of teen girls who have HPV has dropped by more than half. It is important for young people to get vaccinated before they have sex (before they have been exposed to HPV), since people who are already infected with HPV are not protected by the vaccines. There are many strains of HPV, however, so even women with one strain of HPV will benefit from the vaccine, since they will be protected against other strains. The vaccine was found to be safe and effective in women living with HIV. For more information, see our fact sheet on HPV.

Pregnancy and HIV

With the advances in HIV care and treatment, many women are living longer, healthier lives with HIV. As they think about the future, some of these women are deciding to have the babies they always wanted. Women living with HIV who want to become pregnant should discuss their plans with a health care provider who is very experienced in treating women with HIV. For more information, see our fact sheet on Getting Pregnant.

The good news is that advances in HIV treatment have also greatly reduced the chances that a mother will pass HIV on to her child (mother-to-child transmission). If the mother takes appropriate medical precautions, the rate of transmission can be reduced to fewer than one in 100 births. In addition, studies in the US have shown that being pregnant will not make HIV progress faster in the mother. For more information, see our fact sheet on Pregnancy and HIV.

In Conclusion

The number of women living with HIV is growing. It is important that you get tested regularly and do your best to be aware of your risk for HIV. In many countries, including the US, testing for HIV is part of routine health screening and preventive care.

If you test negative, you can take steps to stay that way. If you test positive, you can take steps to stay healthy and prevent passing the virus on to others, including during pregnancy. And while there is no cure yet, many women are living longer and stronger lives with HIV thanks to effective care and treatment.

More research is needed to determine how HIV progresses in women and how HIV drugs affect women’s bodies. However, it does seem that HIV drugs benefit women as much as men. By taking advantage of good health care and treatment as soon as you can, you greatly increase your chances of living a longer and healthier life for you and your loved ones.

The Road Ahead for HIV Cure Research

Today, with better understanding of the complex task at hand, cure researchers are investigating multiple avenues and taking the long view.  This article comes from Benjamin Ryan and was first presented online in Poz.com on January 7, 2019

Cure research and the potential for a cure is still front and centre in many of our lives and this article talks about the road ahead and some of the setbacks that have been suffered along the way.


HIV cure researchers received some disappointing news at the July 2018 International AIDS Conference in Amsterdam. Two studies in particular offered a sobering lesson on how extraordinarily complex developing a safe and effective cure for the virus will likely be.

As conference attendees learned, researchers behind a randomized trial of an HIV cure method, the largest such study to date, recently found that their efforts failed to reduce viral DNA in human participants. The trial, called RIVER, tested the “kick and kill” strategy that seeks to roust latently infected immune cells from their slumber and then kill them off. Standard HIV medications—antiretrovirals, or ARVs—work only against cells that harbor actively replicating virus. These resting infected cells are a chief component of what is known as the viral reservoir, and it’s the stubborn persistence of this reservoir that frustrates cure efforts.

In a second study presented at the conference, an antibody treatment that had shown promise in monkeys failed to prompt what is known as posttreatment control of the virus after HIV-positive humans interrupted their ARV therapy.

As scientists in this field recalibrate their expectations, the use of the term “cure” as a goal for their research is declining. Instead, investigators may seek to induce posttreatment control of HIV, or viral remission, in which a particular therapy would not eradicate the virus from the body but rather suppress HIV over an extended period without the need for long-term ARV treatment.

Nevertheless, the overall field is generally still referred to as HIV cure research.

Taking the pulse of her fellow HIV cure researchers, Sharon R. Lewin, MD, PhD, director of The Peter Doherty Institute for Infection and Immunity at the University of Melbourne in Australia, says, “If anything, there was probably more optimism four years ago because we had tried fewer things. We now know that curing HIV is definitely not an easy task.”

Looking on the bright side, Lewin points to other promising recent cure studies conducted in primates, noting, “We definitely have been able to cure a few monkeys. That’s exciting.”

But as the antibody study presented at the Amsterdam conference indicated, disappointing outcomes among humans might follow success in primate research.

“The preclinical studies have universally shown more favorable outcomes than human studies,” says Jintanat Ananworanich, MD, PhD, who in her capacity as the associate director for therapeutics research at the U.S. Military HIV Research Program directs research in the HIV cure field. “Although no strategies have resulted in remission in clinical trials thus far, tremendous knowledge on HIV persistence and immune responses has been generated. This is important to informing future trials.”

Concerns about recent setbacks notwithstanding, Lewin remains optimistic about the future of HIV cure research. “Science can also take dramatic turns with significant discoveries too,” she says. “So you never know what may change the field dramatically.”

Lewin is the lead author of a literature review recently published in The Lancet HIV, “Barriers and Strategies to Achieve a Cure for HIV,” in which she and her three coauthors offer a comprehensive summary of the impressive number of avenues researchers are pursuing in their quest for a cure, or something close to it. Below, POZ looks at the main takeaways from their paper. We also explore a few HIV cure studies published more recently.

***

Lewin and her colleagues note that the only person ever cured of HIV remains Timothy Ray Brown. As a component of his treatment for leukemia, Brown received stem cell transplants a decade ago from a donor with a genetic mutation that confers natural resistance to the virus—the surface of the donor’s immune cells lacked the CCR5 coreceptor to which most HIV attaches in order to infect the cells. As far as researchers can tell, Brown benefited from a sterilizing cure. There is no evidence in his body of any virus with the capacity to replicate, and his viral load has never rebounded. (Today, Brown actually takes Truvada [tenofovir disoproxil fumarate/emtricitabine] as pre-exposure prophylaxis [PrEP] to ensure he does not contract HIV again.)

Otherwise, in the realm of posttreatment control of HIV, quite a few people with the virus have been able to suppress their viral load for long stretches, sometimes for years, after interrupting standard ARV treatment. A recently published paper found that those who began ARVs very soon after contracting the virus are more likely to achieve such a prolonged state of viral remission after eventually going off their meds. It is likely that beginning on ARVs so promptly after infection keeps the viral reservoir relatively small, thus reducing the likelihood of latently infected cells springing to life at any given moment following a treatment interruption.

One of the most famous cases of such posttreatment control is that of the African child who was treated for HIV for less than a year after birth and, by the time the child’s case was reported in 2017, had spent over eight years in a state of viral remission. In 2015, news surfaced that an 18-year-old French individual had spent 12 years off ARVs and still controlled the virus. Then, of course, there was the 2013 case of “the Mississippi Child”—met with great fanfare—who spent a couple of years off ARVs during her very young life but ultimately, and disappointingly, experienced a viral rebound at 4 years old.

According to Lewin, scientists’ increasingly enriched comprehension of the posttreatment-control phenomenon has actually made designing HIV cure studies more difficult. Now researchers must take into account that some study participants might achieve control of their virus, even if for a short time, without the benefit of an investigative cure therapy, thus making it more challenging to prove that a cure treatment was the cause of viral remission or a delayed viral rebound after the interruption of ARV treatment.

***

Not only do latently infected immune cells evade ARV treatment, but also for every million such cells, perhaps only 60 harbor virus that can actually replicate; the rest contain defective virus. So finding those resting cells capable of waking up and repopulating the body with new virus in the absence of ARV treatment can be akin to finding a needle in a haystack. The immune system itself wastes considerable energy going after cells infected with dud copies of the virus.

In another of the myriad ways HIV has evolved to help ensure it sustains a lifelong infection, latently infected cells have the ability to clone themselves. Perhaps more than half of the viral reservoir cells in some people living with the virus are clones.

The matter of whether HIV continues to replicate at low levels in the face of effective ARV treatment has been the source of significant controversy in the cure field. A study presented at the 2018 Conference on Retroviruses and Opportunistic Infections in Boston found no evidence of such ongoing replication in the lymph nodes, calling into question the notable contrasting findings of a 2016 paper.

***

The lack of precise tests for measuring the viral reservoir remains a considerable obstacle for HIV researchers, both in determining the challenge they face in their quest to vanquish an infection and in assessing how well they did. Currently, scientists in the field must rely on rather crude metrics, such as changes in the overall presence of viral DNA or RNA in the blood, to gauge how a particular treatment affects the size of the reservoir. (HIV carries its genetic code in RNA, which is copied to DNA during infection of a cell.) Such metrics can underestimate the population of infected cells because most virus hides in tissues, not blood.

Scientists may also try to measure success by determining whether an HIV cure treatment is associated with a delay in viral rebound after an interruption of ARV therapy and whether such a treatment is associated with a particular level of control of the virus in the absence of standard ARV therapy for the virus.

If only scientists could identify a specific biomarker, such as a particular protein, that could predict the likelihood of a delay to viral rebound or control of the virus after a treatment interruption. Then, study participants might be spared the burden of interrupting their ARVs, a common requirement in HIV cure study designs. Asking people to stop standard HIV treatment raises ethical questions and may discourage people living with the virus from entering cure trials. That said, multiple studies have indicated that treatment interruptions in cure studies are safe.

Lewin argues that such a tidy biomarker would likely attract greater investment in the field from pharmaceutical companies. (Global funding for public sector HIV cure research increased from $88 million in 2012 to $289 million in 2017, with the lion’s share coming from the National Institutes of Health.) Such for-profit companies prefer study designs boasting a level of simplicity that will help an investigational treatment pass muster with regulatory bodies like the Food and Drug Administration. They also prefer efficient investments for their research and development dollars. So their researchers favor clearly delineated, objective means of measuring success in clinical trials of experimental agents.

Case in point: The recent discovery of a biomarker that can predict whether an individual will achieve a functional cure of hepatitis B virus (HBV) gave rise to a surge of interest from the pharmaceutical industry in researching curative therapies for HBV.

Investment in Cure Research chart

Source: “Global Investment in HIV Cure Research and Development in 2017”

Investment in Cure Research chart

Source: “Global Investment in HIV Cure Research and Development in 2017”

Avenues of Research:

Stem cell transplants

Clinicians are still trying to replicate the success of Timothy Brown’s HIV cure with similar strategies. In recent years, a number of other individuals with cancer have received stem cell transplants from donors who also have the genetic mutation related to the CCR5 coreceptor that confers resistance to the virus. One of the six such individuals whose cases have been published in scientific literature experienced a viral rebound; the other five ultimately died as a result of complications following their stem cell transplant or from their underlying cancer.

In other cases of people living with HIV who received a stem cell transplant but from a donor who lacked the CCR5-related genetic mutation, the stem cell transplant did delay the time to viral rebound by 3 to 10 months after the individuals stopped ARVs.

However, the high fatality rate following transplantation highlights how impractical, not to mention unethical, this method of attempting to cure HIV is for anyone not already facing a high risk of death due to cancer.

Gene therapy

Seeking safer alternatives to cancer-treatment-based stem cell transplants, researchers are experimenting with gene-editing techniques that alter the DNA of an individual’s immune cells. In particular, the scientists will try to deactivate the gene that gives rise to the CCR5 coreceptor, thus robbing HIV of a means of latching onto immune cells. The modified cells are then grown outside the body and ultimately reinfused into the person’s body. The aim is to spawn a population of immune cells that are resistant to infection. As the field of gene editing rapidly evolves, it is hoped that new, even more cutting-edge technology will facilitate progress on the HIV cure front.

“Kick and kill”

The method of waking up latently infected cells (the “kick” part) and then finishing them off (the “kill” part) has yielded some notably disappointing results of late, including those of the RIVER study that was presented at the July conference in Amsterdam. Researchers pursuing this strategy have looked to various cancer drugs known as HDAC inhibitors as the kick element; but thus far, they have not been able to show such drugs can actually diminish reservoir cells.

Lewin remains cautiously optimistic about further research into these medications, noting that the RIVER trial used a less advanced and relatively weak kick agent. Recent, more preliminary studies that have examined other kick agents, such as so-called TLR agonists, have shown far greater promise.

On this front, Gilead Sciences is investigating a drug known as GS-9620 that has shown positive results in primate research.

Latency silencing: “block and lock”

Effectively the opposite of the kick and kill strategy, the “block and lock” method, also known as latency silencing, is based on the presumption that if rooting out and killing all the latently infected cells in the body is too challenging, keeping them in a silent state indefinitely may be a viable alternative. A recent study conducted in mice sought to inhibit a viral protein known as tat that acts as an on-off switch for viral replication in cells. The study successfully reduced the amount of HIV RNA expressed in tissue biopsies taken from the animals, and it delayed viral rebound after the interruption of ARV treatment.

Enhancing the immune system

Researchers are investigating whether vaccines can be used to prompt the body to better control the virus.

Scientists have also invested considerable energy into studying so-called broadly neutralizing antibodies, which are natural antibodies that boast the capacity to combat a wide array of HIV strains. Research has indicated that some of these antibodies are associated with a delay in viral rebound after an ARV treatment interruption. Recently, scientists have gone high-tech by synthesizing three such antibodies into one “trispecific” antibody—a kind of all-in-one triple combination therapy—that has already shown promise in its use as pre-exposure prophylaxis (PrEP) among primates.

Modulating the immune system

Scientists are seeking to manipulate proteins that redirect the traffic of immune-fighting cells. One such example is an antibody called vedolizumab that targets a protein on the surface of CD4 cells and stops these cells from moving into the gut, where HIV focuses much of its assault on the immune system. An initial study in monkeys reported two years ago provided hope for progress in this area of research, but scientists recently repeated the study and found that the antibody had a null impact on the second go-round. Preliminary results in humans also showed that vedolizumab did not affect the time to viral rebound after individuals interrupted their ARV treatment.

Looking to the future

In all likelihood, a successful HIV cure, or posttreatment control, strategy will rely upon a combination approach based on a number of the methods currently under investigation or those yet to be imagined.

“It is clear that achieving HIV remission will not be easy and that one should not expect any single intervention to help people get to remission,” says Jintanat Ananworanich. “We are taking small steps in discovery science.”

Any successful method will need to be safe, effective and—if it is to make a significant dent in the global epidemic—scalable. An HIV cure therapy that is extraordinarily expensive thanks to, for example, the highly involved and complex process required to provide personally tailored genetic editing of an individual’s immune cells, will have little to offer poorer nations—in particular those in sub-Saharan Africa—where the need is greatest.

Curative hepatitis C virus (HCV) treatment, for example, costs tens of thousands of dollars in the United States, which has led insurers to restrict coverage of the medications. The actual cost to manufacture such medications, however, is relatively low, which allows for a steep sliding scale elsewhere around the world.

The future of HIV cure science is also up against the phenomenal success of ARV treatment, which has set a high bar for any alternative means of suppressing the virus. The life expectancy of those on ARVs is approaching normal. What’s more, the risk of transmitting HIV is effectively zero for those who maintain a fully suppressed viral load.

However, such benefits don’t speak to the psychic costs of living with a highly stigmatized lifelong infection or how a cure therapy may alleviate such burdens. Then there are the extreme difficulty and expense of getting the global population on lifelong ARV treatment. Also, even well-treated HIV is associated with an increased risk of numerous health conditions, such as cardiovascular disease and cognitive decline.

Some form of HIV cure could help address these problems. However, as HIV drug development continues to progress and long-acting injectable treatments, or even very long-lasting implants, become the standard of care, emerging HIV cure treatments may cease to offer the freedom from daily medications as an advantage over standard ARV therapy. (Or perhaps by then, long-acting antibody treatments will be the norm.)

Furthermore, if someone is in a state of posttreatment control of the virus, what reassurances will there be that the virus will remain dormant indefinitely and won’t suddenly surge back and make an individual unwittingly infectious? How frequently will people benefiting from viral remission need viral load monitoring?

These pressing questions, along with HIV’s extraordinary complexity, likely make for a long and winding scientific road ahead. But thanks to the increasing funds backing such research and a growing army of top-tier scientists doggedly pursuing a cure, the future will hopefully prove bright with new developments.

Still, this field isn’t simply concerned with a binary outcome of finding the holy grail of a cure or otherwise failing to do so. Success will likely prove incremental, with scientists eventually discovering new means of further mitigating HIV’s long-term harms, further transforming a once surely fatal infection into an increasingly innocuous presence in the body and around the world.

 

AIDS 2018 told the story of a global health crisis

This important article comes from Devex.com and puts the International AIDS Conference into perspective.

AMSTERDAM — The fight to end HIV/AIDS was given a boost by a star-studded week of presentations, panel sessions and the occasional protest at this year’s International AIDS Conference in Amsterdam. However, tensions within the community remain, and with few new funding pledges announced, there are questions about how to translate strong rhetoric into action.

Some 16,000 stakeholders from more than 160 countries gathered in the Dutch capital last week for AIDS 2018, the conference’s 22nd edition and one of the biggest events in the global health calendar, featuring sessions on the latest HIV science, policy, and practice.

The week-long event was awash with celebrities including Elton JohnCharlize Theron, and the United Kingdom’s Prince Harry, as well as former United States President Bill Clinton, who gave the keynote speech at the closing plenary. The heads of the world’s major health donors, notably U.S. President’s Emergency Plan for AIDS Relief, the Global Fund to Fight, AIDS, Tuberculosis and MalariaWorld Health Organization and Joint United Nations Programme on HIV/AIDS were also in attendance.

Held under the theme of “Breaking Barriers, Building Bridges,” the real story of this year’s conference was the growing realization that the HIV/AIDS epidemic is in crisis, with 1.8 million new infections in 2017. There are also alarming spikes in new HIV cases among key groups including adolescent girls in sub-Saharan Africa and drug users in eastern Europe and parts of Asia, according to recent figures from UNAIDS. At the same time, development assistance for HIV dropped $3 billion between 2012 and 2017, according to a study by the Institute for Health Metrics and Evaluation.

“The feel is definitely less congratulatory than past conferences and more sobering,” Rachel Baggaley, coordinator for HIV prevention and testing at WHO, told Devex, but added that it was good to see the community responding with force. The activist spirit which has defined the fight against AIDS in the past was never far away, she noted, with many sessions interrupted by campaigners.

“It is very positive to see the AIDS movement hasn’t gone away … I went feeling rather down and have come away challenged and inspired; there’s a lot of things we must do and a lot of people who continue to take this [AIDS agenda] forward,” she said.

One protest challenged the leadership of the U.N.’s dedicated AIDS agency, UNAIDS, with more than 20 female campaigners interrupting Executive Director Michel Sidibé — who has been criticized for his response to a sexual harassment scandal — during his address on stage at the opening plenary. Sidibé insists he has made changes and has resisted calls to step down, but his presence was a source of controversy.

In terms of funding, the conference saw the launch of the new $1.2 billion MenStar coalition to expand HIV services for men and boys, and £6 million ($7.87 million) in new funding from the U.K. government for grassroots HIV groups, provided through the Robert Carr Fund. The real test, however, will be next year’s Global Fund replenishment in France.

The key now will be turning the strong rhetoric and passion seen throughout AIDS 2018 into action on the ground, according to youth HIV activist Mercy Ngulube.

“We are all going to build bridges this week … but where is your bridge going to lead us? Don’t let your bridge be a bridge to nowhere,” she said during the opening plenary.

Key messages from the week were:

1. Target key populations

Attendees agreed that, without drastic change, the world will see global HIV targets missed and a possible resurgence of the epidemic. But Peter Piot, founding executive director of UNAIDS and now director of the London School of Hygiene and Tropical Medicine, warned the targets themselves could leave key populations even further behind.

Speaking on Thursday, Piot reminded the audience that the 90-90-90 targets set by UNAIDS in 2014 will miss 27 percent of HIV patients. The framework calls for countries to get 90 percent of people living with HIV diagnosed; 90 percent of those diagnosed to be accessing treatment; and 90 percent of people on treatment to have suppressed viral loads by 2020.

“The 90-90-90 targets are actually 90-81-73,” he said, adding that “what the future of the epidemic is going to be determined by is the 10-10-10” — those not hit by the targets.

The 10-10-10 is likely to be made up of key populations including sex workers, men who have sex with men, LGBTI groups, people who inject drugs, and young people — all of whom are less likely to access HIV services due to social stigma, discrimination, criminalization, and other barriers, Piot said. These groups currently account for 47 percent of people with new infections, according to UNAIDS data.

Reaching these key populations was high on the agenda last week. Dudu Dlamini, a campaigner for sex workers’ health and rights who was awarded the Prudence Mabele prize for HIV activism during the conference, spoke to Devex about the need to decriminalize sex work in order to remove barriers to HIV services for sex workers.

Leading HIV scientists also put out a statement in the Journal of the International AIDS Society about laws that criminalize people with HIV for not disclosing their status and for exposing or transmitting the disease. Such laws, which exist in 68 countries, “have not always been guided by the best available scientific and medical evidence,” it said, and when used inappropriately can reinforce stigma and undermine efforts to fight the disease.

2. Prevention pay off

With new infections standing at 1.8 million last year, the recent UNAIDS report describes a “prevention crisis.” Traditionally, prevention has received only a tiny proportion of HIV funding, with the bulk going toward treatment. But there was a new buzz around the prevention agenda at this year’s event, in part driven by excitement around oral pre-exposure prophylaxis, or PrEP, which can prevent HIV infection among those at high risk. The antiretroviral medication has been successfully rolled out in North America, western Europe, and Australia, and has been shown to help reduce new infections among men who have sex with men.

is a highly effective modality of prevention that should be paid for by the health system. No doubt.” – @NIAIDNews Director Anthony S. Fauci
WHO’s Baggaley said PrEP had “energized the prevention agenda.” However, questions remain about the feasibility of rolling it out in low-income countries, and about its efficacy for women.

“There is a prevention crisis and we need to find better ways of addressing it,” said Christine Stegling, executive director of the International HIV/AIDS Alliance. But while PrEP is a promising tool, a full approach to prevention needs to include a range of methods, combined with interventions that tackle human rights issues and gender inequality, she said.

3. A youth bulge

It was impossible to miss the strong youth presence at this year’s AIDS conference, which organizers said had a larger number of young people attending than ever before, and featured dozens of youth-focused events. This is linked to a growing recognition that adolescents face a disproportionately high risk of becoming infected with HIV, especially in Africa where the population is set to rapidly increase, and where new infection rates are on the rise among young people.

Ugandan youth advocate Brian Ahimbisibwe, a volunteer ambassador for the Elizabeth Glaser Pediatric AIDS Foundation, said: “Without the youth, the future of all these conferences, and more importantly [of] services and programs, [is] compromised.”

However, 28-year-old Tikhala Itaye, co-founder of women’s rights group Her Liberty in Malawi, said the youth voice had not been fully integrated and that young people were still being “talked at” during many of the sessions, as opposed to being listened to.

“There’s now acceptance that young people need to be at the center … they do have the demographic weight and power to influence issues around HIV,” she said, but “you still find the different youth events happening in different rooms … Why aren’t we all coming together as one to build the bridges and have a global voice?”

Signs at the 22nd International AIDS Conference in Amsterdam, The Netherlands. Photo by: Marcus Rose / IAS

4. The need for integration

A number of sessions talked about the need to integrate HIV programming, which has traditionally been siloed due to having its own funding streams, into broader health care. This was a key message of The Lancet Commission report on strengthening the HIV response published ahead of the conference, and was also the message delivered by WHO director-general Tedros Adhanom Ghebreyesus during the opening plenary.

“We have not truly helped a child if we treat her for HIV, but do not vaccinate her against measles. We have not truly helped a gay man if we give him PrEP but leave his depression untreated … Universal health coverage means ensuring all people have access to all the services they need, for all diseases and conditions,” he said.

Baggaley said integrating HIV into the broader health agenda posed both “an opportunity and also a challenge and risk for those populations most marginalized,” explaining that key populations currently served by externally funded nonstate health services could see their assistance diminished under UHC if the country in question did not believe UHC includes key populations or had punitive laws against gay men or sex workers, for example.

There was much discussion around the need to combine HIV and tuberculosis efforts, especially in the run up to the first U.N. high-level TB event in September. TB is the number one killer of people with HIV, who are up to 50 times more likely to develop it, according to WHO.

Speaking in between interruptions from the crowd, former U.S. President Clinton highlighted the need to address HIV and TB in tandem during the closing plenary and called on world leaders, notably India which has the highest TB burden, to attend the upcoming U.N. TB meeting.

“If you think … anyone ..that we can possibly bring the developing world to where we want it to be by abandoning the fight against HIV/AIDS and the collateral struggle against TB, you need to think again,” he said.

New findings from the Sustainable East Africa Research in Community Health program, presented during the conference, showed positive results from a community-based program which combined HIV testing and treatment with other diseases including TB, diabetes, and hypertension. The findings of a three-year randomized controlled trial in Kenya and Uganda showed that communities receiving testing and care for HIV alongside related conditions saw nearly 60 percent fewer new TB cases among HIV-infected people and that hypertension control improved by 26 percent.

5. Medical developments

Concerns about GlaxoSmithKline’s so-called “wonder drug” dolutegravir, which a study recently suggested might be linked to serious birth defects among children in Botswana, sparked debate amongst conference goers about whether potential mothers should be prescribed the drug.

WHO already advises that women of childbearing age wishing to take the antiretroviral have access to effective contraception, and will be re-evaluating its guidance as new evidence emerges, Baggaley told Devex. But there are concerns the agency could introduce blanket restrictions for women of childbearing age, which would force them to take other antiretroviral drugs that have worse side effects. The controversy could also lead to delays in the rollout of other forms of the drug, such as a pediatric version.

The conference also featured new data from the APPROACH study, which is evaluating the safety of several different HIV vaccines currently undergoing clinical trials in the U.S., East Africa, South Africa, and Thailand — but researchers admitted a vaccine will take years to develop.

6. The Trump effect

The shadow of U.S. President Donald Trump’s beefed-up “global gag rule,” otherwise known as the Mexico City Policy, loomed large over the conference, and a number of sessions discussed how it is negatively affecting HIV programs. Unlike previous iterations of the policy — which restricts U.S. funding to non-U.S. organizations that offer services related to abortion — Trump’s version is applied to almost all U.S. global health assistance, including PEPFAR.

Santos Simione from AMODEFA, an NGO that offers sexual health and HIV services in Mozambique, said his organization had lost U.S. funding due to the gag rule and was forced to close half of its youth clinics, which offered sexual and reproductive health services alongside HIV testing, counseling, and antiretroviral therapy.

“We could not provide condoms … testing … we just stopped everything,” Simione said.

Participants also spoke of a chilling effect, whereby organizations have stopped offering services that may not actually be prohibited under the rule, and raised concerns about PEPFAR’s staying power within a hostile Trump administration.

Meanwhile, there was heated debate about arrangements for the next conference, which the International AIDS Society has said will take place in San Francisco, California, in 2020. The decision has been met with fierce opposition and threats to boycott the event from AIDS campaigners who say many key population groups affected by HIV will have difficulties attending due to strict immigration policies. In 2009, former U.S. President Barack Obama lifted a restriction banning people with HIV from entering the country, but sex workers and people who use drugs still face legal challenges entering.

Nearly all Australians with HIV can’t transmit the virus — but can its stigma be broken?

As we continue to see improvements in our health we still battle on a daily basis with stigma…

By the time he was 25, Ed Moreno was preparing to die.

He imagined a painful and undignified end — a fate he saw other gay men suffer.

He was diagnosed with human immunodeficiency virus (HIV) in 1990.

“They gave me five years to live,” he said.

“AIDS was killing people in a very ugly way … [there were] disfigurements, painful deaths.”

It was around the height of the AIDS epidemic that was terrifying the world.

Back then AIDS (acquired immunodeficiency syndrome) and its precursor, HIV, were effectively a death sentence. “Telling my parents was probably the hardest thing I’ve ever had to do,” Mr Moreno said.

Mr Moreno resigned himself to the “numbing” thought he would be lucky to reach 30, but his sights were set on going “out with a bang”.

The American moved from his home town of Santa Fe to Miami to party away what remained of his relatively short life.

“I decided I was going to live large,” he said.

The anti-retroviral revolution

However, by the mid-1990s, major medical advances meant that AIDS was no longer a death sentence: it was a chronic condition which could be managed with multiple anti-retroviral drugs.

Mr Moreno started treatment, which at the time involved a complicated cocktail of medications with painful side effects.

Still it wasn’t until 2003, more than a decade after his diagnosis, that he contemplated one day experiencing old age.

“It took me a long time to realise I wasn’t actually going to die,” he said.

“It’s kind of feel like I lost those 13 years.”

Living under the dark cloud

In recent years, HIV treatment has been simplified down to a pill a day.

It is now shown that with effective and sustained treatment, the virus cannot be detected by standard blood tests or transmitted during sex.

More than 26,000 Australians were living with HIV in 2016, according to the Kirby Institute at the University of New South Wales.

Of them, more than 90 per cent had an undetectable viral load.

“A person living with HIV like myself, takes my medication every day,” said Nic Holas from The Institute of Many.

“That one pill stops HIV in its tracks, it stops the virus replicating.”

The organisation is behind a new push to end HIV stigma.

The U=U campaign — which stands for “undetectable equals untransmittable” — involves Mr Moreno and four others sharing their HIV experiences.

Mr Moreno is now 53 and calls Melbourne home. He personally knows the impact of outdated views on HIV.

“I had an experience not too long ago of someone wanting to keep my cutlery and cups separate,” he said.

The gap between science and perception extends to those with the virus, Mr Holas added.

“We’ve been living under a very dark cloud of HIV for many decades,” he said.

“HIV positive people hear it [the U=U message] and [say], ‘Oh, but what if?'”

Mr Holas stressed the U=U campaign was grounded in strong scientific research.

“Some of the greatest scientific minds in the field, at an international level, have endorsed the U=U statement,” Mr Holas said.

“There is effectively zero risk of transmission, so don’t worry about it.”

New South Wales Gay HIV Rate Drops by One Third After PrEP Scale-Up

This is according to the world’s first study to conduct an analysis of PrEP’s apparent effect on the HIV rate on a public-health level.

March 14, 2018  By Benjamin Ryan reposted from Poz.com 

This dramatic shift occurred after the province’s HIV diagnosis rate had held essentially steady during the preceding years. The recent period researchers factored into their analysis saw only relatively modest increases in the HIV population’s viral suppression rate. So treatment as prevention is not likely the primary driver of the considerable change in the HIV rate. (If HIV is fully suppressed with antiretroviral (ARV) treatment it effectively cannot transmit.)

“Really, the main thing that changed by far during this period was PrEP,” said Andrew Grulich, PhD, an HIV epidemiologist at the Kirby Institute at the University of New South Wales in Sydney, who presented findings from the study at the 2018 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

Andrew Grulich speaks at CROI 2018 in Boston.

Andrew Grulich speaks at CROI 2018 in Boston.Benjamin Ryan

Seeking to conduct the world’s first analysis of PrEP’s wide-scale effect on a population’s HIV rate, researchers secured funding from the New South Wales Ministry of Health to start 3,700 people on PrEP beginning in March 2016. The target population included adults who were at a high and ongoing risk for HIV according to local guidelines. Those who had compromised kidney function (an eGFR test result below 60) were excluded.

Those receiving PrEP were scheduled to receive a baseline-screening visit, a one-month follow-up visit and screening visits every three months thereafter.

Demand for PrEP proved considerable: 3,700 people started PrEP within eight months of the study’s launch. Consequently, the investigators behind the study were able to convince the local government to give them greater financial backing; by the end of 12 months, 7,621 individuals had received PrEP.

Of the first 3,700 people, 8 percent were 18 to 24 years old, 36.7 percent were 25 to 34 years old, 29.3 percent were 35 to 44 years old and 26 percent were 45 years old or older. A total of 99.4 percent of the overall group was male, 95.5 percent identified as gay and 4 percent identified as bisexual. A total of 47.1 percent received PrEP from a public sexual health clinic, 48.6 percent from a private general practice and 4.4 percent from a hospital.

Eighty percent of new HIV cases are among MSM in New South Wales, so PrEP was well positioned to make a major dent in the state’s HIV rate given its rapid uptake among this population.

A total of 3,602 people (97.4 percent) received at least one follow-up HIV test during the study. This population was included in one of the key parts of the final analysis.

The study authors looked at a so-called medication possession ratio over 12 months among the individuals receiving PrEP, specifically the estimated percentage of a year’s supply of Truvada that individuals obtained during their first year after initially receiving the drug. The median possession ratio was 97.8 percent, meaning that more than half of those receiving Truvada received almost an entire year’s worth. Seventy percent of the study population received 80 percent of a 12-month supply of the drug, while 14 percent received 50 to 79 percent, 13 percent received 10 to 49 percent and 3 percent received less than 10 percent of a year’s supply within 12 months of first receiving PrEP.

During a cumulative 3,927 years of follow-up among those 3,602 people, two of them tested positive for HIV. One individual was given PrEP but never started it, and the other took no Truvada for months before contracting the virus.

Consequently, the researchers concluded that the study population contracted HIV at the very low rate of five cases per 100,000 cumulative years of life.

The investigators looked at the HIV rate among MSM in New South Wales according to state surveillance from March 2015 through February 2016, the 12-month period before the study began recruiting people, and compared that rate to the one seen during the 12-month period after the study enrolled its first 3,700 people, November 2016 through October 2017.

By the end of this time, the study had recruited 7,621 to start on PrEP.

During the initial 12-month period and the latter 12-month period, MSM in New South Wales saw a respective 149 and 102 diagnoses of HIV that were deemed to be infections MSM had contracted within 12 months. These two periods saw a respective 295 and 211 total HIV diagnoses among MSM, including both recent and more long-term infections. That meant that among MSM in this province, diagnoses of recent HIV infections dropped by 32 percent and all HIV diagnoses fell by 25 percent.

Breaking down the decline in the rate of recent infections among MSM in New South Wales by age, the investigators found that those 18 to 24 years old saw a 9.5 percent decline (21 cases before, 19 after), those 25 to 34 years old saw a 22 percent decline (58 cases before, 45 after), those 35 to 44 years old saw a 44 percent decline (39 cases before, 22 after) and those 45 years old and older saw a 48 percent decline (31 cases before, 16 after).

While the decline in the recent infection rate among those born in Australia or another high-income, English-speaking country dropped by a respective 49 percent (78 cases before, 40 after) and 33 percent (12 cases before, 8 after), the rate for those born in Asia dropped only 21 percent (42 cases before and 33 after) and the rate for those born in other nations actually increased by 24 percent (17 cases before, 21 after).

National Women Living with HIV Day!

Get tested, know your status

07 Mar 2018 – reproduced from NAPWHA

Once again, March 9 commemorates the National Day of Women Living with HIV in Australia. Initiated by the National Network of Women Living with HIV — otherwise known as the Femfatales — the annual day of awareness was conceived due to concerns that Australian women are too often unaware about the risks and realities of HIV. “We wanted to start conversations so that all women have an opportunity to increase their knowledge and awareness about HIV,” said Femfatales Chair, Kath Leane.

Now into its third year, the national day continues to grow and is observed by local events held all around Australia. The key message this year is Get Tested, Know Your Status to encourage and empower women to take control of their own health by getting tested for HIV.

There are currently around 3,000 women living with HIV in Australia. Yet women are often not considered to be at risk of acquiring HIV. As a result, they are less likely to test for the virus. We need to change this by normalising the testing procedure and thereby reducing the stigma around HIV.

Having an HIV test should be something women include as part of their regular sexual health check-up. The more women test for HIV, the more we will be able to diagnose and treat women appropriately, address the gaps in testing, and tailor the experience to suit women.

It is vital that the barriers and gaps in testing for women around HIV are recognised so that women are not left behind. Nearly half of heterosexual people diagnosed with HIV in 2017 had a late diagnosis, which means they were likely to have acquired HIV at least four years before the positive result — and had been unaware of their status all that time. Being diagnosed late can result in serious health challenges due to a compromised immune system.

It is hoped that the National Day of Women Living with HIV in Australia will help not only raise the profile of women with HIV, and help reduce stigma, but also — importantly — encourage women to test. “In 2018, Femfatales is advocating the importance of knowing your own HIV status, which requires having an HIV test and taking charge of your sexual health,” said Leane. “This is the aim of this special day.”

Study suggests many gay and bisexual men are skeptical, but attitudes are on the rise about U=U

First published on January 11, 2018, The City University of New York

Dr. Jonathon Rendina, an Assistant Professor at Hunter College and Director of Quantitative Methods at Hunter’s Center for HIV Educational Studies & Training, and Dr. Jeffrey Parsons, Distinguished Professor at Hunter and Director of CHEST, have published a new paper in the Journal of the International AIDS Society focused on gay and bisexual men’s perceptions of the HIV treatment-as-prevention message, “Undetectable = Untransmittable.” Numerous well-controlled trials have recently demonstrated that there is effectively no risk of HIV transmission during sex with a partner who has a sustained, undetectable viral load. This notion, that HIV treatment can lead to HIV prevention, has been captured with the #UequalsU slogan popularized by Bruce Richman and the Prevention Access Campaign, of which he is Executive Director, and has gained growing popularity and endorsements, including the U.S. Centers for Disease Control and Prevention (CDC). The Hunter CHEST study sought to examine how accurate gay and bisexual men perceive this message to be by surveying more than 12,000 men across the United States in the summer of 2017.

In addition to promoting HIV knowledge, one goal of the message is to help reduce HIV stigma. Mr. Richman noted, “This study underscores the great need for further targeted educational and dissemination strategies and provides data that will be immensely valuable as we work with our partners to scale up campaigns to prevent new transmissions and reduce HIV stigma.” Among HIV-positive men, reporting a detectable viral load was associated with believing the message was less accurate. Dr. Rendina added, “What we may be seeing is that some guys who aren’t able to maintain a sustained undetectable viral load either have lower levels of knowledge potentially due to being less well-retained in care or that they may feel left out of the message and concerned it will lead to additional stigma placed on them.” He continued, “There is great promise for the message to reduce HIV stigma, but at the same we need to make sure we don’t end up marginalizing or stigmatizing those who struggle with keeping their viral loads undetectable.”

Among men with and without HIV, believing the message was more accurate was associated with having had condomless anal sex with a partner of a different HIV status. Dr. Parsons noted, “This suggests that men who understand the scientific evidence, now endorsed by the CDC, that Undetectable = Untransmittable feel more comfortable having condomless sex when a positive partner is virally suppressed. Because they know that treatment-as prevention is effective—as with other forms of biomedical prevention, like PrEP, it’s giving men more options regarding their sexual health that emphasize autonomy and sexual pleasure. The message of ‘use a condom every time’ is now outdated and limiting.” Strategies such as regular viral load monitoring, efforts to maintain medication adherence, routine screening for sexually transmitted infections, better access to PrEP, and promoting communication about biomedical prevention with sexual partners can be helpful in conjunction with treatment-as- to continue curbing the HIV epidemic and averting new epidemics among other .

Finally! The Sexy Gay PrEP Video We’ve Been Waiting For.

This article and the links to the videos first appeared in June on Poz.com  and was written by Mark King.  As we move closer to the PrEPIT WA trail launching here in Perth it is a great time to look at these videos because they share some important information. Even though they are from the US the basics are the same and the messages just as relevant.

And so, without a dime of governmental or pharmaceutical funding, Chris used an assignment for his master’s degree in cinema to create “The PrEP Project,” a four-part video series that speaks honestly — and quite explicitly — to gay men about their sex lives and why more of them should be using PrEP.

The result is the sexiest (and maybe funniest) video series on the topic anyone has produced to date. It’s exactly what PrEP advocates have been waiting for, because it isn’t beholden to stiff health department guidelines or even political correctness.

Stop everything and watch it right this minute, as long as your boss doesn’t mind some bare ass and explicit sex talk. Each episode is only five minutes.

Did I mention the series features leatherman sexpert Eric Paul Leue, as well as a gay porn star and a muscle boy also known as a drag performer? You’ve got to give points to Chris for pure resourcefulness. Better yet, aside from the eye candy, the series is adorably engaging.

The first classic prevention message that Chris refused to promote in the video was “use a condom every time.” The vast majority of people, gay or straight, do not use condoms consistently. “The rate of consistent condom use among gay men has been estimated to be as low as 17%,” Chris says, “and PrEP is the answer to that. But we still conflate condom use with morality, which just isn’t helpful.” Instead, the film speaks to the sex lives of gay men as they actually are.

The initial backlash against PrEP as an alternative to condoms — the “Truvada Whore“ argument — doesn’t bother Chris. He knows where it comes from. ”Condoms became an emotional topic,“ he says, after a generation of mortality that provided no other options. ”Now that there is an alternative, people have a hard time letting that message go.”

Rest assured, “The PrEP Project” outlines the risk of other sexually transmitted infections that can occur without condoms. It just refuses to draw a false equivalency between the consequences of HIV and those of other STI’s.

When the first video in the series launched on Facebook, it got more than 40,000 views in the first day. That is, until Facebook pulled it down for violating their irksome, often vague community standards. “That really pissed me off,” Chris admits. “I should have expected it because it is somewhat graphic sex, but I believe the people who pulled it didn’t like the message. It wasn’t about the sex. I got a lot of hate mail.”

Lucky for you, the entire series is included in this post. Enjoy!

Mark

 

https://www.poz.com/blog/finally-sexy-gay-prep-video-waiting

Beyond Positive Workshop Series

Beyond Positive is a workshop series for HIV Positive Gay and Homosexually Active Men.

Topics include Sex, Intimacy and Relationships, Stigma & Discrimination, Disclosure & Empowerment, Treatments as Prevention, Living Well and more.

Facilitated by Mark Reid, the Positive Peer Educator. The workshops will run weekly on a Tuesday evening from 6:30pm from November 14th to December 12th.

  • Tuesday November 14th
  • Tuesday November 21st
  • Tuesday November 28th
  • Tuesday December 5th
  • Tuesday December 12th

Evaluation and Debrief on Tuesday December 12th followed by dinner at 7.30pm. If have any special dietary requirements please let Mark know when you RSVP.

If you’re interested in this event, please contact:
Mark Reid on 9482 0000 or email mreid@waaids.com by Tuesday October 31st 2017 to secure a place.

Not linked in with the WA AIDS Council? Not to worry. If you haven’t connected with the WA AIDS Council previously and would like to register for this event, please contact Alli at apaterson@waaids.com or on 9482 0000, who will explain how you can get involved.

Struggle, Self-Love & Survival: Growing Old With HIV

September 18, 2017  By AIDS United

The following is a guest post by Eric Jannke of Let’s Kick ASS Palm Springs, published in coordination with National HIV/AIDS and Aging Awareness Day (NHAAD), held each September 18 to call attention to the challenges that older Americans face in terms of HIV prevention, testing, care and treatment.

 

Me, getting old with HIV. This was not the plan. This was not the plan at all.

I grew up assuming a lot of things about the world. Like there would always be health. That was such a deep assumption that I didn’t recognize it as one until it went away. Maybe that’s how it generally is, we notice the absence of things we’re accustomed to.

But it did go away, my health. I was careful, but somehow got HIV anyway. I honestly don’t know who or how, and have always been grateful for that. No blame. Life happens.

I ask a lot of questions. I want to know other people’s thoughts. The world I grew up in, there was one right way to do just about everything. The world I know now has many right ways, or no right ways, depending on how you look at it. I asked people their thoughts about HIV & Aging. What was most important?

More research, said one. Acceptance, said another. A positive attitude, said a third. A positive attitude? Really?

Before 1996, when HIV infection was a certain death sentence, we all developed survival strategies. It’s hard to believe they worked since so many people using the same strategies died. Having a positive attitude was one of those strategies. Somehow we were encouraged to experience beatitude through the hell of this illness. It encouraged us to look inwards, some said. “You have to understand that it is a gift,” we were told. “A gift,” said one friend. “If it’s a gift, I want the receipt. I’m taking it back, and I don’t want anything else they have.” And now, 30 unexpected years later, someone says to me positive attitude. We talk, and agree that if nothing else, it makes living easier. Staying mostly positive doesn’t happen by itself. It happens because we make it.

——————-

I’m part of the leadership for a group called Let’s Kick ASS Palm Springs. ASS stands for AIDS Survivor Syndrome. You don’t have to be HIV positive to have it. Think of it as a variation of PTSD (post-traumatic stress disorder). It is a very real thing.

Watching your friends die—tens, dozens, hundreds of people you have known and cared for—it screws with you. As a young man, I moved to San Francisco to be part of a community and to fit in somewhere, but when I got there I found that the community was busy dying. Everyone close to that community, infected with HIV or not, was traumatized by the magnitude and horror of the loss.

It isn’t a pretty way to die. One friend had more than 70 perforated ulcers lining his digestive tract, starting in the back of his mouth, down his esophagus, ending inside his rectum. It took him two years to die, even with all those holes. I would stand with him on the fire escape, keeping him from blowing away in the fierce winds, so he could have a cigarette. He didn’t get to age with HIV. I’ve been infected longer than he was ever alive.

Readily visible in our community are isolation, depression, a struggle to find meaning. People are isolated because they have lost so many of their friends. They are isolated by their own physical limitations. They are isolated by poverty. Many of us had to leave careers that were just getting started, freezing our incomes at that level. What was a livable income in 1994 is significantly less so in 2017. We stopped work because we had to. We were dying. I know people who were ordered to go on disability by their boss, compassionately, who refused to let them die at work. Then some of us didn’t die. And then we realized that we weren’t going to die of AIDS after all, that the new drugs it was so hard to believe in were actually working.

Today, our Kaposi’s sarcoma lesions are mostly gone, replaced by more common skin cancers. AIDS is gone, now classified as stage 3 HIV infection. HIV no longer means get your affairs in order, make peace with the world you have known and be ready to leave it, uncomfortably. Now we are living with a manageable chronic illness, and living means aging. It can mean aging with an immune system that never fully recovers. Some of us spent too long with single digit T-cell counts, and that measure of immune health will never go into a truly healthy range. The best we can do is get out of the “you will die from every passing infectious agent” range. Some of my friends won’t travel by air anymore. Others travel with antibiotics for the inevitable bronchial infections contracted on planes.

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Last week I traveled with my box of antibiotics to the United States Conference on AIDS (USCA), representing Let’s Kick ASS Palm Springs. I was lucky enough to get an HIV 50+ scholarship, and the National Minority AIDS Council covered all my expenses. We had a day of visits to Capitol Hill, asking for continued funding to support HIV research and existing programs to prevent more infections. We were a bunch of people in varying stages of infirmity, reminding the world that we still exist, we still need care, and that we don’t want anyone else to go through this. If we can pull that off, our lives will feel worthwhile.

HIV research is human research. We all have immune systems, and we know a lot more about them because people, scientists, have dedicated their lives to chasing tiny bits of answers to questions we barely know enough to ask. Because of their dedication we have fewer AIDS-related deaths now, but fewer deaths also means more people living longer and growing older with HIV. Even on our meds, aging with HIV means dealing with a host of co-morbidities (independently diagnosable conditions associated with aging) possibly decades before they would typically become issues for people not infected with HIV. HIV specialists are becoming gerontologists not because they want to, but because they have to. It’s difficult to untangle causation from correlation in all these issues. Is it the HIV itself or side effects of the medications? Is 50 the new 75, and what about long-term inflammation?

Answering these questions and, ultimately, ending the HIV epidemic takes a lot of time, money, and ingenuity. It also takes a lot of dialogue. The HIV epidemic can only go away by acknowledging it is here and by finding ways to talk about it that everyone can understand.

Talking about HIV and aging means talking about how we achieve, or do not achieve, health care in our society. It means talking about poverty. About race. And gender, and sexuality. None of these are comfortable topics for most Americans. But there is no logic to support continuing silence. While we don’t talk, people are still being infected, at all ages from adolescents to octogenarians. This is morally unacceptable. It’s also expensive. It’s expensive to stop the epidemic, but it is so much more expensive not to.

When Is There Zero Risk of Transmitting HIV?

 More leading health experts and organizations endorse “Undetectable = Untransmittable.” This is a great article that raises some important points to consider! Reprinted from The Advocate.

Over the past year, hundreds have joined the growing list of health experts and organizations around the world to endorse the Undetectable Equals Untransmittable Consensus Statement. The U=U Consensus states that a person living with HIV who has an undetectable viral load through treatment cannot transmit the virus to a sexual partner.

Issued by the Prevention Access Campaign, U=U is based upon the findings of two major scientific studies on transmission risk: HPTN 052 and PARTNER, and a smaller study called “Opposites Attract.” In all of the studies, there were no transmissions of HIV (between serodiscordant, or mixed-status, couples) when the partner living with HIV was undetectable. Over 58,000 sex acts were counted in one of the studies with not a single transmission.

Global HIV and AIDS resource NAM AIDSMap is the latest to endorse the consensus. “The scientific evidence is clear,” says Matthew Hodson, NAM’s executive director. “Someone who has undetectable levels of virus in their blood does not pose an infection risk to their sexual partners.”

Many experts are now using the terminology “zero chance” in regards to the risk of transmission when a person’s viral load is vundetectable. For those living with HIV, this is vital and life-changing information that can not only influence one’s physical health, but have an enormous impact on mental and emotional health as well. U=U will help end the HIV epidemic and may even aid in eliminating stigma.

“The fear of catching HIV from a sexual partner fuels HIV stigma,” Hodson explains. “Which is why it’s so important that the ‘undetectable equals untransmittable’ message is heard and understood. Those of us with diagnosed HIV have had to live with the idea that our bodies are dangerous. This has had a profound emotional impact on many people.”

Last year, Bruce Richman, executive director of Prevention Access Campaign, unveiled the short documentary film Undetectable = Untransmittable (produced by Linus Ignatius). Richman says, “Exaggerating the ‘danger’ we are to others is an act of violence against all of us with HIV, and makes us vulnerable to a myriad of harms and injustices. We deserve and demand accurate and meaningful information that is not only critical to our social, sexual, and reproductive health, but is essential to end the epidemic.”

International HIV Conference Reveals Exciting Progress in Global HIV Fight

Highlights from the research presented at the 9th International AIDS Society Conference on HIV Science in Paris. Thanks to the team at Poz.com for this great coverage that I think makes interesting reading.

August 22, 2017  By Benjamin Ryan

The fight to combat the global HIV epidemic is charting exciting progress on numerous fronts. This includes a rapidly increasing proportion of those living with the virus on treatment as well as falling infection and AIDS-related death rates. Additionally, there have been various promising advances in research into new antiretroviral (ARV) treatments and forms of pre-exposure prophylaxis (PrEP), not to mention vaccines and means of prompting long-term viral remission that may allow some people with the virus to stop taking daily drugs.

The more than 7,000 HIV researchers and advocates who attended the 9th International AIDS Society Conference on HIV Science (IAS 2017), which took place in Paris from July 23 to 26, learned of these and other signs of great hope for the future of the worldwide epidemic. However, they were also confronted with the finer details of the considerable challenges ahead, most notably flat or declining funding from wealthy donor nations for efforts to fight the epidemic in poorer nations.

To follow is a summary of the major findings presented at the conference. Click on the hyperlinks for greater detail about any of the studies. For a complete newsfeed of all IAS 2017 reporting, click here.

Linda-Gail Bekker, PhD, the International AIDS Society (IAS) President and International Scientific Chair of IAS 2017 in Paris, speaking at the opening sessionBenjamin Ryan

Global Treatment

major announcement from Joint United Nations Programme on HIV/AIDS (UNAIDS) kicked off the conference: An estimated half of all people living with HIV worldwide,19.5 million out of 36.7 million, are now on ARV treatment. According to a lengthy UNAIDS report on the state of the global epidemic, in 2016 an estimated 70 percent of the global HIV population had been diagnosed, 77 percent of those diagnosed were on ARVs and 82 percent of those on ARVs had a fully suppressed viral load. Since 2014, UNAIDS has pushed nations to get each of those three figures to 90 percent, otherwise known as the 90-90-90 targets.

Treatment rates have soared while new infections and AIDS-related deaths have dropped considerably in eastern and southern Africa in particular. Meanwhile, Central Asia and Eastern Europe is the only major region that has seen a worsening epidemic, with its HIV infection rate rising 60 percent and its AIDS-related death rate rising 27 percent during the 2010s.

UNAIDS

UNAIDS

Excitingly, a highly reliable survey conducted in Swaziland and presented at IAS 2017 found that in just five years the hard-hit nation had doubled the proportion of its HIV population on ARVs while cutting its new infection rate in half.

Velephi Okello of the Swaziland Ministry of Health at IAS 2017 in ParisBenjamin Ryan

Globally, people with HIV are starting ARV treatment progressively earlier. However, the median CD4 count at treatment initiation remains above 350, indicating that considerable work needs to be done to move closer to treating everyone living with the virus, as recommended by the World Health Organization (WHO).

The continued flat funding seen in recent years for the effort to fight HIV in lower-income nations threatens progress in treating HIV on a grand scale. One analysis presented at the conference projected that if funding continues only at current levels, the proportion of people with the virus on treatment and virally suppressed will stagnate accordingly.

Jessica McGillen, PhD, presents a key slide that projects the impact of U.S. funding on viral suppression rates in 18 sub-Saharan African nations.Courtesy of Benjamin Ryan

Another threat to progress fighting global HIV is WHO’s finding that HIV drug resistance is on the rise. In numerous nations recently surveyed, 10 percent of those starting HIV treatment had a strain of virus resistant to some of the most widely used ARVs.

HIV Treatment as Prevention

Yet another study has seen no transmissions within a large cohort of partners when the HIV-positive member of a mixed-HIV-status couple is on ARVs and has an undetectable viral load. Between the Opposites Attract study reported at the Paris conference and the previously reported PARTNER study, there are now data on about 35,000 condomless sex acts between such gay male partners without a single HIV transmission. The PARTNER and HPTN 052 studies have also seen no transmissions between heterosexual partners within such a context. The PARTNER study is currently in a new phase to gather more data from gay male couples.

According to scientific experts discussing these collected research findings at the Paris conference, the risk of transmitting HIV through condomless sex when an individual has an undetectable viral load is so vanishingly small that it is effectively zero.

Another study presented at the conference raised worries about how poor adherence to ARVs among youths may compromise the powerful effects of HIV treatment as prevention. An analysis of 13- to 24-year-olds receiving ARV treatment in Philadelphia found that about one in six were episodically at high risk of transmitting the virus.

PhiladelphiaIstock

Viral Remission

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), says he no longer talks about an effort to develop an HIV cure, per se. Instead, he prefers the goal of prompting “viral remission” or “post-treatment control” of the virus, in which an individual maintains an undetectable viral load without daily ARV treatment. Conference attendees learned that a 9-year-old South African child has been in such a state for eight years, following just 40 weeks of ARV treatment begun after the child contracted the virus at birth.

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), speaking at IAS 2017Benjamin Ryan

An additional presented case study described how a man who contracted HIV only days before starting Truvada (tenofovir disoproxil fumarate/emtricitabine) as PrEP and who was quickly put on a full HIV treatment regimen spent seven months off treatment before experiencing a viral rebound.

HIV Prevention, Including Vaccines

A major push in the HIV research field is to find effective so-called broadly neutralizing antibodies against the virus for use in vaccines, as PrEP or as treatment. Addressing concerns about how to mass-produce such antibodies, one team of researchers found that they could prompt their production by immunizing calves.

In an early-stage study, one HIV vaccine candidate showed promise by prompting a robust immune response in a small collection of volunteers. Pending the results of another study, this vaccine may go into an advanced global trial as soon as late 2017.

Following definitive studies showing that voluntary medical male circumcision reduces female-to-male HIV transmission by about 60 percent, there has been a massive effort to circumcise men in sub-Saharan Africa in recent years. Research over the past few years has begun to show that this endeavor has likely driven down infection rates among men. Now, a study presented at IAS 2017 indicated that women also likely benefit from the male circumcision push, with lower rates of associated HIV and herpes simplex virus type 2.

Cancer

major forum exploring how much HIV and cancer treatment researchers have to learn from and share with one another as they develop highly advanced forms of treatment preceded the conference. The two fields share the goal of overcoming the immune system’s inability to combat a malignant force, be it a tumor or HIV-infected immune cells.

HIV Drug Development

The long-acting injectable regimen of cabotegravir and Edurant (rilpivirine) given every four or eight weeks successfully suppressed HIV over a 96-week period among 90 percent of participants in a major trial.

Gilead Sciences recently applied for approval from the U.S. Food and Drug Administration (FDA) of its new combination tablet of the experimental integrase inhibitor bictegravir plus the contents of the company’s Descovy (emtricitabine/tenofovir alafenamide). The FDA granted the tablet priority review; a decision is expected by February 12, 2018. A study presented at IAS 2017 found that compared with other approved regimens, this combination had fewer side effects and was similarly effective in suppressing HIV among those starting ARVs for the first time.

Another study found that the first single-tablet regimen containing a protease inhibitor, specifically Prezista (darunavir), was highly effective in suppressing HIV. When combined with Tybost (cobicistat) and Descovy (emtricitabine/tenofovir alafenamide), Prezista led to a continued undetectable viral load among 96 percent of those who switched from a successful multi-tablet ARV regimen.

Additionally, a recent study found that among first-timers to HIV treatment, a new single-tablet combo regimen containing the investigational non-nucleoside reverse transcriptase inhibitor doravirine, Epivir (lamivudine) and Viread (tenofovir disoproxil fumarate) causes fewer central nervous system and metabolic side effects and is as effective as Atripla (efavirenz/tenofovir disoproxil fumarate/emtricitabine).

PrEP

Researchers are fast at work exploring new forms of PrEP to help address issues such as toxicity, adherence and the need for novel, female-specific forms of HIV prevention.

One study validated ongoing advanced research into a long-acting injectable form of PrEP, finding that long-acting cabotegravir given every eight weeks was well tolerated and yielded drug levels expected to afford maximum protection against HIV. Additionally, a study of a vaginal ring form of PrEP given to teenage girls in the United States found that an ARV-containing monthly ring was safe and that the participants used it well.

Various studies addressed the ongoing question of how starting PrEP affects sexual risk taking and rates of sexually transmitted infections (STI) among men who have sex with men (MSM). An analysisof British MSM on Truvada for HIV prevention found that they tended to fold PrEP into their set of personal HIV risk-reduction rules, sometimes easing those rules when taking PrEP. Self-reporting indicated that the men did not tend to simply abandon condoms wholesale. Meanwhile, a long-term study of MSM in the United States found that those who started PrEP tended to proceed to report higher rates of condomless sex with casual partners, in particular with HIV-positive partners.

At London’s 56 Dean Street, the city’s main sexual health clinic catering to MSM, gonorrhea diagnoses fell 24 percent between 2015 and 2016 while HIV rates dropped 42 percent. This occurred as use of PrEP soared among men using the clinic’s services and as the clinic, instigated impressive new policies to encourage HIV and STI testing and to treat individuals for both types of infections as soon after diagnosis as possible.

The 56 Dean Street clinic in LondonBenjamin Ryan

PrEP use in the United States continues to increase, reaching the current estimate of 136,000 users. However, the rate of increase in those starting PrEP seen in each progressive quarter has slowed (in other words, about the same number of people are beginning PrEP each quarter). Troublingly, PrEP use is apparently still largely relegated to white MSM age 25 and older, raising concerns that those at the very highest risk for the virus, young Black MSM in particular, will for the most part fail to benefit from the highly effective HIV prevention method that has now been on the market for five years.

new analysis found that the non-daily dosing protocol for PrEP, known as on-demand PrEP, studied in the French and Canadian IPERGAY trial of high-risk MSM worked well even when the men had sex infrequently. There have been concerns that the high level of protection seen among men in the study, who were instructed to take Truvada only in the couple of days surrounding sex, was likely a by-product of the fact that the men tended to have sex so frequently that they often wound up maintaining a relatively steady level of Truvada in their bloodstream—rather than the result of the particulars of the dosing protocol.

separate study of Dutch MSM examined the reasons why they preferred on-demand versus daily PrEP, as well as their reasons for switching between the protocols or stopping them altogether. An expectation of better adhering to one protocol over another was found to be a major deciding factor. Additionally, a national survey of U.S. MSM found that concerns about the cost of PrEP and associated side effects are major barriers to men using Truvada for prevention.

Long-Acting Injectable HIV Treatment Moves Closer to Reality

Interesting reading from TheBody.com about long-acting injectable HIV treatment.

Long-acting injectable treatment takes another step closer to becoming a real-world option for people living with HIV. The latest 96-week data from the LATTE-2 study, which is investigating long-acting injectable maintenance therapy for people with HIV, were presented at the 2017 International Conference on HIV Science, in Paris.

While viral suppression rates were very high, another notable finding was how much participants appreciated not having to take pills every day — another sign that long-acting treatment could translate well to the real world and become the future of medication adherence.

What Is Maintenance Therapy?

“Maintenance therapy” is the concept that, after people with HIV achieve and sustain an undetectable viral load through current conventional means (a treatment regimen of at least one pill once a day, containing three or four drugs) for an extended period, they can switch to a regimen containing fewer drugs (either one or two). The idea is that they can take fewer drugs, thereby being exposed to less toxicity while still maintaining an undetectable viral load.

This is not yet a standard practice in real-world settings, but it could eventually mean that, instead of taking a pill containing three or four drugs every day, you take a pill containing only two. However, the LATTE-2 study takes this idea even further and proposes that, instead of taking a pill every day, people could receive an injection of long-acting drugs lasting up to four or eight weeks.

LATTE-2 Study Background

Since the study started a couple of years ago, the results have continued to be very promising (particularly last year’s 48-week data), and the current 96-week data are equally positive.

The study began with an “induction phase,” during which all participants were put on a daily oral treatment regimen containing cabotegravir and Epzicom (Abacavir/3TC, Kivexa). After 20 weeks, those who achieved an undetectable viral load (286 participants) were then randomized to receive one of three options:

  1. A long-acting injectable regimen containing cabotegravir + Edurant (rilpivirine) every four weeks (the Q4W group).
  2. A long-acting injectable regimen containing cabotegravir + Edurant every eight weeks (the Q8W group).
  3. The previous daily oral regimen of cabotegravir and Epzicom (the control group).

LATTE-2 Study Results

After 96 weeks, 94% of those in the Q8W group maintained an undetectable viral load, compared with 87% in the Q4W group and 84% in the oral control group.

“Serious adverse events,” meaning occurrences that are considered severe or damaging (but not necessarily a reaction or side effect), occurred in 10% of the Q8W group, 10% of the Q4W group and 13% of the control group, but the researchers noted that none were related to the drug.

Severe drug-related adverse events were reported in 2% of the Q4W group, 4% of the Q4W group and 2% of the control group. The most common drug-related adverse events were cold-like symptoms, headache and diarrhea.

Injection site reactions, meaning pain or discomfort felt afterward at the part of the body where the injection took place, were common (97% in the Q8W group and 96% in the Q4W group) but were mostly mild and moderate, with less than 1% being classified as severe.

In terms of “virologic failure,” meaning the treatment wasn’t able to keep the person’s viral load undetectable, there were only two cases in the Q8W group, one in the control group and none in the Q4W group. Out of these, only one in the Q8W group was linked to drug resistance (when a person’s HIV develops resistance against a drug that the person is taking). However, none of these occurred after week 48 and up to week 96.

Freedom From Daily Pills

Perhaps more important than viral suppression data was the overwhelming satisfaction felt by study participants about not having to take pills every day.

Based on a survey, 99% of the Q8W group and 97% of the Q4W group reported being very satisfied with their current treatment, compared with 91% of the control group. When asked how satisfied they would be to continue their current treatment, 99% of both the Q8W and Q4W groups expressed the desire to continue long-acting injectable treatment, compared with only 78% of the control group.

“It’s surprising to me — patients at our site that are on the study — how much they appreciate not having to take pills. I think that’s something that I really didn’t calculate. There’s this kind of feeling of freeness from being bound to oral therapy every day,” said lead study author Joseph Eron Jr., M.D., at an IAS 2017 press conference.

For now, the injections have to be administered by health care professionals, but the drug manufacturers are looking at potential ways to make the regimen self-administered.

The injectable drug regimen will move on into phase-3 clinical trials, two of which are fully enrolled, according to Eron.

Warren Tong is the senior science editor for TheBody.com and TheBodyPRO.com.

Follow Warren on Twitter: @WarrenAtTheBody.