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.

Smoking Pot Related to Higher Lung Disease Risk in HIV-Positive Men

Researchers compared lung disease diagnoses among groups of HIV-positive and HIV-negative men who reported marijuana use.

This article points to some interesting research and was written by Benjamin Ryan from Poz.com   


Among men who have sex with men (MSM) living with HIV, smoking marijuana is associated with a higher risk of both infectious and noninfectious lung diseases.

Publishing their findings in EClinicalMedicine, researchers studied 1996 to 2014 data on men from the Multicenter AIDS Cohort Study (MACS), a long-term observational cohort of HIV-positive and HIV-negative MSM. Participants eligible for this particular prospective cohort study were 30 years old or older and had provided self-reported data on marijuana and tobacco smoking during biannual study visits.

The study included 1,352 HIV-positive men who were matched with the same number of HIV-negative men according to race and the age at which they entered the study. Between them, the cohort members made 53,794 study visits and were followed for a median of 10.5 years.

Twenty-seven percent of the HIV-positive men and 18 percent of the HIV-negative men reported smoking marijuana daily or weekly during one or more years of follow-up, for use that lasted for a median of 4.0 and 4.5 years, respectively.

The cohort members received 1,630 diagnoses of lung diseases during follow-up. A total of 33.2 percent of the HIV-positive men and 21.5 percent of the HIV-negative men were diagnosed with infectious lung disease, and a respective 20.6 percent and 17.2 percent were diagnosed with noninfectious lung disease.

Among the men living with HIV, recent marijuana smoking was associated with a 43 percent higher risk of infectious lung disease and a 54 percent higher risk of noninfectious lung disease independent of tobacco smoking and other risk factors for lung disease. When HIV-positive men smoked both marijuana and tobacco, these risks were higher.

There was no association between recent marijuana smoking and lung disease risk among the HIV-negative men.

The study’s strength included its large sample size, the high number of lung diagnoses and the lenghty follow-up time.

“These findings could be used to reduce modifiable risks of lung disease in high-risk populations,” the study authors concluded.

To read the study, click here.

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.

 

Even When Well Treated, HIV Is Linked to Advanced Aging

Researchers analyzed 10 biomarkers associated with biological aging among a group of HIV-positive and -negative Europeans.

This article is a reprint from POZ.com  from January 17, 2019  By Benjamin Ryan

Publishing their findings in the journal AIDS, researchers from the ComorBidity in Relation to AIDS (COBRA) study analyzed 134 people with HIV and 79 HIV-negative people with similar sociodemographic and lifestyle factors. The participants were recruited in Amsterdam (these were at least 45 years old) and London (these were at least 50 years old).

All the HIV-positive individuals were on antiretrovirals and had had a fully suppressed viral load for at least 12 months.

The researchers also studied samples from 35 blood donors selected from the Dutch national blood bank in Amsterdam. They were matched with the HIV-positive and -negative individuals from the COBRA study according to age and had all tested negative for HIV, hepatitis B and C viruses (HBV/HCV), syphilis and human T-lymphotropic virus 1 and 2 (HTLV).

The investigators tested the participants for 10 biomarkers that previous research has indicated are associated with biological, as opposed to chronological, aging.

Among the COBRA study members, biological age was greater than chronological age by an average of 13.2 years among those with HIV and 5.5 years among those without the virus. For the blood donors, biological age was an average of 7.0 years lower than chronological age.

After adjusting the data for various factors, including HIV status, the study authors found that the following factors were significantly associated with a greater average biological age compared with chronological age: chronic HBV, 10.05 years; total anti-cytomegalovirus (CMV) IgG antibody levels, 1.83 years per 10-fold increase; and CD8 cell count, 0.44 years per 100-cell increase.

After adjusting for chronic HBV infection status, total anti-CMV IgG antibody levels and CD8 levels, the analysis indicated that the HIV-positive COBRA participants had a greater discrepancy between biological and chronological age compared with their HIV-negative counterparts (4.5 years on average) and with the blood donors (19.0 years on average).

After conducting another analysis in which they adjusted the data for various factors, the study authors found that HIV-related factors associated with a greater biological age compared with chronological age included: cumulative exposure to the antiretroviral Invirase (saquinavir), 1.17 years per year of exposure; a lowest-ever (nadir) CD4 count of less than 300, 3.0 years; chronic HBV, 7.35 years; and total anti-CMV IgG antibody level, 1.86 years per 10-fold increase.

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.

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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 .

Peer Mentor Program set to launch in Perth!

Living with HIV has changed over the past 3 – 4 years.  With modern treatment and support, HIV positive people can lead healthy and active lives.  Learning how to do this does not have to be overwhelming, and no one needs to be isolated or alone.

The WA AIDS Council Peer Mentoring Service can provide the most current HIV information, answer questions, offer support and show how other people deal with HIV.

Peer Mentors are trained and educated on the current health issues surrounding HIV/AIDS, STI’s, self-care, disease progression, co-morbidities, HIV and aging and well-being.  Through a series of supportive discussions, they use everyday language instead of jargon or medical terminology to make topics easier to understand.

The role of a Peer Mentor is to support a person with HIV to gain knowledge and develop HIV self-management strategies, providing the important information need to achieve goals while living with HIV.

Talking with someone who is living with HIV can reduce the stress and anxiety that some people experience and also reduce isolation.  Having good mental health and social supports are important to keep HIV in check, improve emotional health in areas of self-esteem, depression, stigma and discrimination, battling isolation and building support networks.

Here in Western Australia, we are located in the largest state in Australia and the ability to reach out and work with people with HIV who are more rural and isolated is another aim of the Peer Mentors.  Through the use of modern technology such as Skype the ability to keep people connected and supported will help to reduce that sense of isolation that can be detrimental to living positively.

A Peer Mentor  is an HIV positive person who can assist other HIV positive people who are newly diagnosed or who are needing support from someone who is living with HIV to:

  • Improve emotional health
  • Understand current treatments and the role of treatments as prevention in the HIV lived experience
  • Develop disclosure strategies for meeting personal challenges
  • Navigate ‘well-being’.

The program is not limited to those who have been newly diagnosed but is also open to any person living with HIV who might want to address some of their health concerns.  Peer Mentors can assist with support around changing medications, dealing with co-morbidities and the issues of ageing while living with HIV, maximizing quality of life and also to assist in connecting people with appropriate services.

On Tuesday January 23 we will be holding an information night that will tell you more about the project and how you can be involved.

If this sounds like something you might be interested in  then please email me at mreid@waaids.com or call me in the office on (08) 9482 0000.

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

A journey over 30 years of living with HIV

POZ STORIES

I was fortunate to have been asked to submit this article to POZ.com and it was recently published so I thought I would share it with you!

Mark Reid

October 6, 2017

Positive since 1987

2017 marks the 30th year since I was diagnosed with HIV, and it also marks the 22nd year that I have worked at the Western Australian AIDS Council in Perth. This has been an incredible journey on so many levels. I moved to the AIDS Council after working for five years at a local PLWHA [People Living With HIV/AIDS] organization.

In that time, I have worked locally and nationally on a range of different committees and groups that have advocated, raised funds and worked directly with other people living with HIV. I have met some really amazing people on this journey.This year, I returned to the position that I held when I first joined the AIDS Council: HIV-positive peer educator. It is just amazing to once again work directly with people living with HIV.

Those very early days were never easy. I had some incredible triumphs and much heartache, as I watched many of my close friends and peers lose their battle with HIV. There were too many funerals, too much grief and too many tears. But through all that, a sense of hope never left me.

I was always hopeful that we would turn a corner, that we would get to the time when HIV would be a manageable illness (at least for those of us fortunate enough to live in the developed world) and that I could stop having to say goodbye to some amazing people in my life. When I reflect, I remember all those gorgeous men and women who played such an important part in my life who I no longer have the honor to see anymore but still hold in my heart.

I have been blessed for the past 35 years to have the most amazing partner. He has been on my journey with me. We have shared so much, experienced a lot and grown together through this epidemic. I also have been blessed to have coparented two children and now have five divine grandchildren who make my desire to live a full and complete life so strong.

There have certainly been some complications over the past 30 years, but I don’t think any life is ever easy. I have had a number of challenges post-diagnosis. Probably the most serious was when I had rapid onset Guillain-Barré syndrome nearly three years ago and had a total shutdown of my nervous system. My lungs collapsed. I had to spend 12 days in intensive care and have a tracheotomy to allow me to breathe. I dealt with five complete plasma replacement treatments to eradicate my body and then had to learn how to walk again, among other things.

I have to say, though, that my life has been filled with much love, laughter, blessings, joy and happiness. I continue to focus on the positive to allow me to live an amazing life. I have worked with, known and made friends with people in this amazing HIV community, which I am also honored to be a part of. Every day, I am thankful to still be here and to still be working with and alongside other people living with HIV as we continue to build resilience, reduce stigma and discrimination and educate people.

What three adjectives best describe you?

I see myself as a person who surrounds himself with positive energy, determination to do my very best in all aspects of my life and filled with much love.

What is your greatest achievement?

My children and grandchildren.

What is your greatest regret?

I try not to have regrets in my life and to focus on the positive.

What keeps you up at night?

Sometimes, I do worry too much, which keeps me up at night.

If you could change one thing about living with HIV, what would it be?

This is the hand that I have been dealt, so there is nothing that I would change. Everything that happens is a life lesson that hopefully makes me a better human being.

What is the best advice you ever received?

Stay positive, stay focused and never lose sight of the end point.

What person in the HIV/AIDS community do you most admire?

Nic Holas, one of the founding members of TIM (The Institute of Many), a closed Facebook group in Australia that allows people to connect, share stories and socialize with other people living with HIV.

What drives you to do what you do?

Compassion, love, passion and the desire to make a difference.

What is your motto?

Live life to the fullest each and every day, but never forget to sometimes stop, just breathe and enjoy the wonder around you.

If you had to evacuate your house immediately, what is the one thing you would grab on the way out?

My partner.

If you could be any animal, what would you be? And why?

An eagle, so that I can soar up high and survey the wonder of the world.