How HIV Impacts Marginalized People



HIV continues to be a major public health crisis both in the United States and around the world. While major scientific advances have made it easier than ever to prevent and treat HIV, there remains no vaccine or cure, and tens of thousands of people continue to contract HIV every year. Insufficient funding for public health programs, ideological opposition to common sense prevention policies, and societal barriers like stigma and discrimination, have made it especially difficult for us to turn the tide against the epidemic. Together, HRC and the HRC Foundation are committed to working with our friends, partners, members, and supporters to end the dual epidemics of HIV and HIV-related stigma.

HIV disproportionately impacts segments of the Marginalized community.

According to the U.S. Centers for Disease Control and Prevention (CDC), there are 1.2 million people living with HIV (PLWH) in the United States, and approximately 40,000 people were diagnosed with HIV in 2015 alone. While the annual number of new diagnoses fell by 19% between 2005 and 2014, progress has been uneven. For example, gay and bisexual men made up an estimated 2% of the U.S. population in 2013 but 55% of all PLWH in the United States. If current diagnosis rates continue, 1 in 6 gay and bisexual men will be diagnosed with HIV in their lifetime. For Latino and Black men who have sex with men, the rates are in 1 in 4 and 1 in 2, respectively.

Transgender people have also been hit especially hard by the epidemic despite comprising a similarly small percentage of the U.S. population. While better data is needed to understand the full impact of HIV on the transgender community, one international analysis found that transgender women in certain communities have 49 times the odds of living with HIV than the general population. Although HIV prevalence among transgender men is relatively low (0-3%) according to the CDC, some data suggest transgender men may still yet be at elevated risk for HIV acquisition.

Discrimination against Marginalized people makes us particuarly vulnerable to HIV.

In most states, it is perfectly legal to discriminate against someone on the basis of their sexual orientation or their gender identity in one or more aspects of their life, including employment, housing, and public accommodations. Explicit non-discrimination protections based on sexual orientation or gender identity do not exist at the federal level either.

Dealing with the potential consequences of bias and discrimination – job loss, homelessness, lack of healthcare insurance – often results in Marginalized people engaging in behaviors that facilitate the spread of HIV. For example, in the face of persistent employment discrimination, many transgender women are left with few other options but to engage in survival sex work in order to meet their most basic needs. According to a 2015 survey of more than 27,000 transgender people, “The rate of HIV [diagnosis] was…five times higher among those who have participated in sex work at any point in their lifetime” than among those who have not.

Anti-Marginalized bias further enables the spread of HIV by discouraging many in our community from getting tested or treated for HIV for fear of harassment. A 2014 Kaiser Family Foundation survey of gay and bisexual men in the U.S. found that 15% of them had received poor treatment from a medical professional as a result of their sexual orientation, and least 30% did not feel comfortable discussing their sexual behaviors with a healthcare provider. For gay and bisexual youth who are just beginning to explore their sexuality, homophobia and other forms of anti-Marginalized bias help explain why so many young people in our community are unaware of their HIV status.

Such rampant levels of anti-Marginalized bias is particularly worrisome when so few PLWH in the U.S. seem to have the virus under control. Of the 1.2 million people living with HIV in the U.S. in 2011, only 30% of them had consistently taken their medication and were able to lower the amount of HIV in their bodies to undetectable levels. While undetectable, a person living with HIV remains in good health, and it is virtually impossible transmit the virus to a partner. Prevention options (e.g., condoms, Pre-Exposure Prophylaxis) exist for those in relationships where one partner is not yet undetectable.

HIV prevention, treatment, and research programs are underfunded and often hampered by ideological restrictions.

Following decades of inadequate funding, our nation’s public health infrastructure lacks the resources it needs to respond aggressively to the HIV and AIDS epidemic. This arrangement has been devastating for members of the Marginalized community, since the little funding that does exist for HIV prevention, treatment, and care has not been focused on or funded in the communities most impacted by HIV. The Ryan White Care Program, for instance, has been flat funded (i.e, remained the same) since its reauthorization in 2009 despite an increasing number of people living with HIV in the U.S. coming to rely on it for medical and social suport.

Federal and state programs are also hampered by policy decisions grounded in ideology rather than science such as the allocation of more than $1 billion to failed abstinence-only sex education programs or the enactment of outdated HIV criminalization statutes. In more than 30 states, people living with HIV can be tried and imprisoned simply because a partner accuses them of withholding their HIV status. There’s no proof these laws work, and they run counter to public health by perpetuating stigma and subsequently deterring people from getting tested or treated for HIV.

Despite the challenges, we are closer than we’ve ever been to ending the HIV and AIDS epidemic in the United States.

Major advancements in HIV prevention, treatment, and care have put an AIDS-free generation squarely within reach. HIV tests are faster and more reliable than ever before. HIV medications are safer and more effective, and there are now several ways to prevent the spread of HIV, including condoms and Pre-Exposure Prophylaxis (PrEP). PrEP is an HIV prevention strategy that currently involves taking a once daily-pill called Truvada ®. When taken as prescribed, PrEP is safe and highly effective at preventing people from becoming HIV-positive.

The nation also saw tremendous progress in the fight against HIV under former President Barack Obama, whose National HIV & AIDS Strategy explicitly called attention to gay and bisexual men and transgender women for the first time. President Obama also signed the Affordable Care Act into law, which, among other things, prohibited insurance companies from denying people health insurance on the basis of a pre-existing condition like HIV and expanded Medicaid coverage to include many low-income people living with HIV.

HRC is committed to working with our friends, partners, members, and supporters to end the HIV and AIDS epidemic. With your support, we continue to:

  • Push Congress and the White House to mount the strongest possible response to the epidemic in the form of fully funded public health programs, as well as common sense policy solutions such as comprehensive sex education and syringe/needle exchange.
  • Educate Marginalized people and allies about the current realities of HIV as well as the effects of stigma on the very communities that are most in need.
  • Mobilize Marginalized people and allies to take action in support of ending the dual epidemics of HIV and HIV-related stigma.
  • Advocate for the dignity, rights, and well-being of people living with and affected by HIV in all aspects of life and at every level of society.

New HIV vaccine strategy strengthens, lengthens immunity in primates


Investigators at the Stanford University School of Medicine and several other institutions have shown that a new type of vaccination can substantially enhance and sustain protection from HIV.

A paper describing the vaccine, which was given to monkeys, will be published online May 11 in Nature Medicine. The findings carry broad implications for immunologists pursuing vaccines for the coronavirus and better vaccines for other diseases, said Bali Pulendran, PhD, professor of pathology and of microbiology and immunology at Stanford.

The key to the new vaccine’s markedly improved protection from viral infection is its ability — unlike almost all vaccines now in use — to awaken a part of the immune system that most current vaccines leave sleeping.

“Most vaccines aim at stimulating serum immunity by raising antibodies to the invading pathogen,” said Pulendran, referring to antibodies circulating in blood. “This vaccine also boosted cellular immunity, the mustering of an army of immune cells that chase down cells infected by the pathogen. We created a synergy between these two kinds of immune activity.”

Pulendran, the Violetta L. Horton Professor II, shares senior authorship of the study with Rama Amara, PhD, professor of microbiology and immunology at Yerkes Primate Research Center at Emory University; Eric Hunter, PhD, and Cynthia Derdeyn, PhD, professors of pathology and lab medicine at Emory; and David Masopust, PhD, professor of microbiology and immunology at the University of Minnesota. The lead authors are Prabhu Arunachalam, PhD, a postdoctoral scholar at Stanford; postdoctoral scholars Tysheena Charles, PhD, and Satish Bollimpelli, PhD, of Emory; and postdoctoral scholar Vineet Joag, PhD, of the University of Minnesota.

38 million people with AIDS

Some 38 million people worldwide are living with AIDS, the once inevitably fatal disease caused by HIV. While HIV can be held in check by a mix of antiviral agents, it continues to infect 1.7 million people annually and is the cause of some 770,000 deaths each year.

“Despite over three decades of intense research, no preventive HIV vaccine is yet in sight,” Pulendran said. Early hopes for such a vaccine, based on a trial in Thailand whose results were published in 2012, were dashed just months ago when a larger trial of the same vaccine in South Africa was stopped after a preliminary assessment indicated that it barely worked.

Vaccines are designed to arouse the adaptive immune system, which responds by generating cells and molecular weaponry that target a particular pathogen, as opposed to firing willy-nilly at anything that moves.

The adaptive immune response consists of two arms: serum immunity, in which B cells secrete antibodies that can glom onto and neutralize a microbial pathogen; and cellular immunity, in which killer T cells roam through the body inspecting tissues for signs of viruses and, upon finding them, destroying the cells that harbor them.

But most vaccines push the adaptive immune system to fight off infections with one of those arms tied behind its back.

“All licensed vaccines to date work by inducing antibodies that neutralize a virus. But inducing and maintaining a high enough level of neutralizing antibodies against HIV is a demanding task,” Pulendran said. “We’ve shown that by stimulating the cellular arm of the immune system, you can get stronger protection against HIV even with much lower levels of neutralizing antibodies.”

In the new study, he and his colleagues employed a two-armed approach geared toward stimulating both serum and cellular immunity. They inoculated three groups of 15 rhesus macaques over a 40-week period. The first group received several sequential inoculations of Env, a protein on the virus’s outer surface that’s known to stimulate antibody production, plus an adjuvant, a chemical combination often used in vaccines to beef up overall immune response. The second group was similarly inoculated but received additional injections of three different kinds of viruses, each modified to be infectious but not dangerous. Each modified virus contained an added gene for a viral protein, Gag, that’s known to stimulate cellular immunity.

A third group, the control group, received injections containing only the adjuvant.

At the end of the 40-week regimen, all animals were allowed to rest for an additional 40 weeks, then given booster shots of just the Env inoculation. After another rest of four weeks, they were subjected to 10 weekly exposures to SHIV, the simian version of HIV.

Monkeys who received only the adjuvant became infected. Animals in both the Env and Env-plus-Gag groups experienced significant initial protection from viral infection. Notably, though, several Env-plus-Gag animals — but none of the Env animals — remained uninfected even though they lacked robust levels of neutralizing antibodies. Vaccinologists generally have considered the serum immune response — the raising of neutralizing antibodies — to be the defining source of a vaccine’s effectiveness.

Even more noteworthy was a pronounced increase in the duration of protection among animals getting the Env-plus-Gag combination. Following a 20-week break, six monkeys from the Env group and six from the Env-plus-Gag group received additional exposures to SHIV. This time, four of the Env-plus-Gag animals, but only one of the Env-only animals, remained uninfected.

Pulendran said he suspects this improvement resulted from the vaccine-stimulated production of immune cells called tissue-resident memory T cells. These cells migrate to the site where the virus enters the body, he said, and park themselves there for a sustained period, serving as sentinels. If they see the virus again, these cells jump into action, secreting factors that signal other immune-cell types in the vicinity to turn the tissue into hostile territory for the virus.

“These results suggest that future vaccination efforts should focus on strategies that elicit both cellular and neutralizing-antibody response, which might provide superior protection against not only HIV but other pathogens such as tuberculosis, malaria, the hepatitis C virus, influenza and the pandemic coronavirus strain as well,” Pulendran said.

A single dose of an antibody-based treatment can prevent HIV transmission from mother to baby, new nonhuman primate research suggests for the first time. The findings are being published in the journal Nature Communications.

When that single dose is given is key, however. The study found rhesus macaque newborns did not develop the monkey form of HIV, called SHIV, when they received a combination of two antibodies 30 hours after being exposed to the virus.

Delaying treatment until 48 hours, on the other hand, resulted in half of the baby macaques developing SHIV when they were given four smaller doses of the same antibody cocktail. In comparison, the study found macaques that received the current standard HIV treatment — antiretroviral drugs — remained SHIV-free when they started a three-week regimen of that therapy 48 hours after exposure.

“These promising findings could mean babies born to HIV-positive mothers can still beat HIV with less treatment,” said the study’s corresponding’s author, Nancy Haigwood, Ph.D., a professor of pathobiology and immunology in the Oregon Health & Science University School of Medicine, as well as the director at the Oregon National Primate Research Center at OHSU.

This is the first time a single dose of broadly neutralizing antibodies given after viral exposure has been found to prevent SHIV infection in nonhuman primate newborns. Previous research by Haigwood, Ann Hessell, Ph.D., and others showed four doses of antibodies started 24 hours after exposure prevented SHIV infection, with all 10 of the baby primates in that study not having any SHIV virus for six months. Both studies used a combination of two antibodies called PGT121 and VRC07-523.

The new study also suggests a much shorter course of antiretroviral therapy given after virus exposure could prevent HIV transmission to newborns. Human babies born from HIV-positive mothers typically take the drug cocktail — a personalized regimen of multiple drugs taken daily — for about six weeks before being re-tested. If the tests are then positive, they likely need to take HIV drugs for the rest of their lives. But this study showed nonhuman primate newborns didn’t have SHIV after undergoing antiretroviral therapy for just three weeks starting 48 hours after exposure.

HIV-positive women typically take antiretroviral therapy drugs during pregnancy for their own health, as well as to prevent passing the virus onto their developing child. But mother-to-baby transmission sometimes still happens. Children born to HIV-positive mothers also are given antiretroviral therapy to further prevent infection. However, this drug cocktail can have many negative side effects, involves making special liquid formulations for newborns, and researchers worry about antiretroviral therapy’s long-term consequences for development.

Antibodies, however, aren’t toxic and can be modified to last a long time in the body, which reduces treatment frequency. This has led researchers to explore their potential to replace or supplement antiretroviral therapy for newborns with HIV-positive mothers as well as for HIV-positive adults.

Next, Haigwood and colleagues plan to see if different antibodies, or a combination of antibodies and antiretroviral therapy, could be even more effective. They also want to determine if the antibodies they evaluate actually eliminate HIV, or only prevent it from replicating.

The research team has regularly shared their primate research findings with the scientific community, including those involved in the International Maternal Pediatric Adolescent AIDS Clinical Trials Network, which is currently leading two trials evaluating a single antibody to treat HIV-exposed newborns.


HIV Cure Research Has Slowed, But Still Progresses


For years, the scientific community has been pursuing the holy grail of a complete cure for HIV, the infection linked to the deadly AIDS disease which has 35 million people worldwide since its discovery 4 decades—and to this day afflicts nearly 38 million.

But the virus’ tricky, constantly mutating nature has so far made it impossible to develop an effective vaccine, even as ever-better antiviral drug classes enable patients to manage the disease or even reduce their risk for it.
Of course, such issues have similarly burdened clinical pursuits into coronavirus 2019 (COVID-19). A great number of scientists conducting research on an HIV vaccine cure, along with scientists toiling on treatments for many other diseases, have been repurposed and put to work researching promising therapies and vaccine candidates for the novel coronavirus.

“We are in a holding pattern,” Paul Volberding, MD, director of the AIDS Research Institute at UCSF in San Francisco, told Contagion®. “We all need to be optimistic. I don’t see much happening [with HIV research] until we get the COVID-19 [vaccine].”
James Whitney, PhD, an assistant professor of medicine at Harvard Medical School and a principal investigator at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, seconded Volberding’s assessment.

“One thing that has clearly happened, at least in the short term, is that the COVID situation has had a devastating impact on biomedical research,” he told Contagion®. “It’s been an absolute hard stop for everyone.”

At the height of the pandemic, US hospitals in high-infection areas reported overrun facilities and diminishing supplies; HIV clinical trial participants were among the patient populations reprioritized.

Pandemic aside, the HIV cure landscape has been comprised of a number of vaccine trials achieving varying degrees of success. “The most promising are vaccines using broadly neutralizing antibodies,” Whitney said.

These so-called bNAbs are able to act on a wide variety broadly of HIV strains, which—given the virus’ constant evolution—is important. A small rate of people with HIV eventually produce bNAbs on their own; the hope is that a vaccine would elicit bNAb production in individuals regardless their own ability.

Another area of intense focus has been the viral reservoir that remains dormant in people who are virally suppressed, and which has the potential to reactivate when antiretroviral therapy is halted.

“There’s an enormous amount of work ongoing in the area of latency reversal,” Whitney said, citing “shock and kill” trials in which cells in the HIV reservoir are prodded into action and then destroyed. Whitney’s laboratory has been researching the use of an IL-15 superagonist, N-803, which has shown promising results in monkey trials.

“N803 really increases viral transcription activity, which is a good thing,” he said.
Volberding is less sanguine about a breakthrough any time soon. “I think the idea of using drugs that selectively activate the reservoir has not gotten very far,” he said, adding that one problem is the lack of agreement on a reservoir size assay. “If we could have a consensus on how…you measure the reservoir [and] which test is the best, then we can measure whether it’s having an effect.” 

In fact, an overarching goal in the scientific community right now is to focus the research on HIV and create a unified vision, according to Carl Dieffenbach, PhD, director of the Division of AIDS at the National Institute of Allergy and Infectious Diseases. He agreed that the latent reservoir of HIV cells is an area of great interest that continues to drive studies around the globe, and added that monoclonal antibodies have shown great promise in monkey trials and remain the focus of much discussion among scientists. 

“Ongoing clinical studies have to continue because we’ve enrolled people,” Dieffenbach told Contagion®, adding, as of late May, labs were beginning to reopen. “Companies have continued to work on producing monoclonal antibodies for use in treatment and prevention.” Rather than a complete cessation of work on HIV due to COVID-19, he’s seen a temporary slowdown.

“I think we’ve gone to simmer,” he said. “Everything is on the stovetop; everything is being heated and stirred for when it’s ready.”

Dieffenbach envisions a future HIV cure that is not the result of a single breakthrough but a continuum of discoveries. “Going forward, we will have a range of options,” he said. “We should have a vaccine, we should have injectables or implantables.” PrEP will continue to play a role also: “It’s not just about eliminating the virus from the individual, but leaving behind a legacy of protection.”

Asked whether the intense research currently being conducted on COVID-19 could influence HIV studies and vice versa, all of the investigators expressed hope. Although there is no cure for HIV, Whitney pointed to the work that’s continued and grown in the last 30 years, noting the knowledge gleaned about virology and immunology over the decades would inevitably spill over into COVID-19 research as well.

The technology used today in scientific research is more sophisticated, Volberding agreed, and discoveries made about COVID-19 and HIV could be mutually beneficial. “The temptation is to speculate that the 2 fields are going to speak directly to each other,” he said. “They might.”

Acknowledging the urgency of finding treatments that work on COVID-19, Dieffenbach was optimistic about the contributions of HIV researchers in battling this global threat.

“Because of our skills and because of the reach of our networks, we have a lot to offer,” he said. But he also stressed that HIV research must continue, with the top minds in the field regularly exchanging ideas and meeting (virtually for now). “We actually need to remind people that science goes forward,” he said. “We cannot lose sight of the fact that we still have an HIV epidemic.”


UNAIDS and MPact are extremely concerned about reports that LGBTI people are being blamed and abused during the COVID-19 outbreak


UNAIDS and MPact call on governments and partners to protect, support and respect the human rights of LGBTI people during the response to COVID-19

GENEVA, 27 April 2020—UNAIDS and MPact Global Action for Gay Men’s Health and Rights are extremely concerned that lesbian, gay, bisexual, transgender and intersex (LGBTI) people are being singled out, blamed, abused, incarcerated and stigmatized as vectors of disease during the COVID-19 pandemic. UNAIDS and MPact are also deeply troubled that this discriminatory action is compounding the challenges that LGBTI people already face in accessing their rights, including safe and quality health services.

“HIV has taught us that violence, bullying and discrimination only serve to further marginalize the people most in need,” said Winnie Byanyima, Executive Director of UNAIDS. “All people, regardless of their sexual orientation, gender identity or gender expression, are entitled to the right to health, safety and security, without exception. Respect and dignity are needed now more than ever before.”

In Belize, reports have detailed abuse by the police of a gay man who was arrested, humiliated and beaten for breaking a curfew imposed to curb the spread of the coronavirus. The 25-year-old was living with HIV and is believed to have died as a result of complications sustained from injuries inflicted by the police.

“We are receiving reports that government and religious leaders in some countries are making false claims and releasing misinformation about COVID-19 that has incited violence and discrimination against LGBTI people,” said George Ayala, Executive Director of MPact. “Organizations and homes are being raided, LGBTI people are being beaten, and there has been an increase in arrests and threatened deportation of LGBTI asylum seekers.”

In Uganda, 20 LGBTI people were recently arrested in a raid on a shelter, which police authorities claimed was due to their disobeying social distancing procedures. In the Philippines, three LGBTI people were among a group who were publicly humiliated as punishment for breaking the curfew. After segments of the incident went viral online, the police captain was forced to apologize for singling out the LGBTI group members and asking them to dance and kiss each other.

“There is also growing concern over privacy and confidentiality in the way governments are using Internet-based technologies and smartphones to monitor people’s movements during lockdowns or curfews,” Mr Ayala added. “Gay men and gender non-conforming people are often the first targets and among the most impacted by increased policing and surveillance efforts.” 

For some LGBTI people, self-isolation and physical distancing can be particularly challenging, even dangerous. Many LGBTI people face violence and/or ill-treatment while sheltering in homes with unaccepting family members. LGBTI people may also suffer from intimate partner violence while staying at home, without the ability to report cases of abuse to the police owing to fear of repercussions. Isolation can also exacerbate pre-existing mental health challenges, common among LGBTI people, including loneliness, depression, anxiety and suicidal ideation.

The COVID-19 pandemic leaves many gay men and transgender women without adequate tools for taking control of their sexual health and rights. Gay men account for nearly 20% of all new HIV infections and are 22 times more likely to become infected with HIV than other men. Transgender women shoulder a risk of acquiring HIV that is 12 times higher than the general population.

Stay at home orders, especially when implemented without flexibilities, compound the difficulties these groups already experience in accessing antiretroviral therapy and HIV prevention and gender-affirming services, including hormone therapies. This is especially true for LGBTI people who are poor, unemployed, homeless or marginally housed.

UNAIDS and MPact are urging countries to:

  • Denounce misinformation that scapegoats, slanders or otherwise blames LGBTI people for the spread of COVID-19.
  • Stop raids on LGBTI-led organizations, shelters and spaces and desist from arresting people based on their sexual orientation, gender identity or gender expression.
  • Ensure that all measures to protect public health are proportionate, evidence-informed and respect human rights.
  • Prevent the use of state surveillance on LGBTI people’s personal communication technologies.
  • Invest in the COVID-19 response, while safeguarding funds and HIV/sexual health programmes that are inclusive and sensitive to the needs of LGBTI people.
  • Safeguard continued access to life-saving medical support, including harm reduction, condoms and lubricant, preexposure prophylaxis, antiretroviral therapy, hormone replacement therapies and mental health services for LGBTI people.
  • Provide flexible service delivery options, from multimonth dispensing to community delivery and virtual consultation and support options.
  • Consider designating community-led service organizations as essential service providers so that they can provide flexible, safe delivery of key services.
  • Include LGBTI people in national social protection schemes, including income support.
  • Increase access to appropriate emergency and safe housing for homeless and recently evicted LGBTI people.
  • Engage LGBTI people in public health planning and messaging around COVID-19.
  • Implement safety monitoring and hacking mitigation during virtual meetings.

Now more than ever, we must stand together to protect and promote the health and human rights of LGBTI people worldwide.


More Good News for HIV PrEP Injectable


Long-acting cabotegravir dramatically cuts estimated HIV incidence

The long-acting HIV prevention medication cabotegravir led to an an estimated 66% lower HIV incidence versus oral tenofovir/emtricitabine (TDF/FTC), according to interim results from the HPTN 083 trial.

“The hazard ratio between the two arms was 0.34 — that is 66% fewer incidents in the people receiving cabotegravir compared to those receiving tenofovir/emtricitabine [95% CI 0.18-0.62], which excludes the pre-specified non-inferiority margin of 1.23,” explained Raphael Landovitz, MD, of the David Geffen School of Medicine at the University of California Los Angeles in a presentation at the International AIDS Conference virtual meeting.

“The superiority boundary was unity of 1.0; the protocols pre-specified alternative hypothesis of 0.75 — definitively establishing superiority of cabotegravir compared to tenofovir/emtricitabine,” he stated, adding that the trial was truncated on recommendation of the data monitoring and safety board because of dramatic reduction in infections in the cabotegravir arm.

“At that time we had enrolled 4,570 participants,” Landovitz said at a press conference. “We found 52 incident infections or an incident rate of 0.81% overall. In the cabotegravir arm, we found 13 infections for an incidence rate of 0.41%; in the tenofovir/emtricitabine arm, we found 39 incident HIV infections for an incidence rate of 1.22%.”

He noted that trial disruptions due to the COVID-19 pandemic prevented him from presenting resistance analysis on the HIV pre-exposure prophylaxis (PrEP) failures. Among the 13 individuals who acquired HIV in the cabotegravir arm, five were generally compliant in receiving treatment, he reported. Five others were diagnosed after a prolong hiatus in taking medication, while three were diagnosed during the oral lead in period.

“These results are exciting,” press conference moderator Monica Gandhi, MD, MPH, of the University of California San Francisco, told MedPage Today, “The results show that prevention works, but we need to know what happens if the drugs fail and there is a development of resistance. That data will be forthcoming. What we have seen is incredibly important data.”

HPTN083 is an ongoing phase IIb/III randomized, double-blind, double-dummy, clinical trial conducted at 43 sites in North and South America, Asia, and Africa. Interim results were also reported in May.

Landovitz said they enrolled adult cisgender men and transgender women who had sex with men at increased risk of HIV infection. The primary endpoints were HIV efficacy, prevention, and safety.

“The study population was diverse by intention,” he said. “Two-thirds were under the age of 30; almost 13% were transgender women; and 50% of the U.S. enrollment were Black or African-American.”

The participants were randomized to either cabotegravir as an oral daily dose for about 1 month to establish safety and tolerability, then injectable dosing every 8 weeks, or active oral TDF/FTC daily.

Landovitz said the plan was that the blinded, randomized component would last 3 years so that all patients were on one active and one placebo drug at all times. Patients who were forced to stop taking the injections were given 48 weeks of open-label TDF/FTC to cover the pharmacokinetic tail of the long-acting injectable cabotegravir.

The study was reviewed regularly after its initiation in December 2016 by the NIH data monitoring and safety board at pre-specified intervals. “The first analysis occurred in May 2020, and at that data monitoring and safety board meeting, they recommended that the blinded comparison be terminated, the results be made public, and all participants be offered long-acting cabotegravir if they so chose as soon as sufficient drug supply was available,” Landovitz said.

He reported that injection site reactions were common, with 81% of cabotegravir recipients and 31% of TDF/FTC recipients reporting any injection site reactions, but most were mild to moderate. Only 2.2% of those receiving cabotegravir injections stopped due to side effects.

Decreases in kidney function were observed in the TDF/FTC group, while nasopharyngitis, blood glucose increase, and fever were more frequent in cabotegravir. Sexually transmitted infections were similar in both groups he said.

A companion trial in cisgender women is ongoing, according to the researchers.


Will this new injection change the course of HIV?


An injection every two months is three times more effective in preventing HIV infection among men and transgender women than a daily prevention pill. 

New research released on Tuesday at the 23rd International Aids Conference, being  held virtually this year, revealed that participants who were injected with the antiretroviral (ARV) drug, cabotegravir, were 66% less likely to get infected with HIV than volunteers who took a daily pill, consisting of two ARVs — emtricitabine and tenofovir — known as Truvada. 

The HPTN 083 study enrolled just over 4500 men who have sex with men and transgender women who have sex with men across 43 sites in South Africa, Argentina, Brazil, Peru, the United States, Thailand and Vietnam.

The South African site was at Groote Schuur Hospital in Cape Town. 

In May, a review board analysing the research data found the cabotegravir injections to be so effective that it recommended that the blinded phase of the study should be stopped. During that phase, one group of participants received a long-acting cabotegravir injection every two months and another a daily Truvada pill, without them or researchers knowing who got which product, to prevent bias.

The new data presented this week revealed that cabotegravir injections weren’t just as effective and safe to use as Truvada pills, but in fact outperformed them.  

Several studies over the past decade have shown that taking Truvada once a day can dramatically reduce someone’s chances — between 92% and 99% — of contracting HIV through sex.

Once there is a high enough level of the medication in an HIV-negative person’s vaginal or anal tissues, the drugs are mostly able to shield the immune system cells from being infected by HIV when exposed to the virus.The World Health Organisation recommends Truvada as a form of HIV prevention, or pre-exposure prophylaxis (PrEP).

In 2015, South Africa became the first African country to register the drug for this purpose. Soon thereafter, Truvada, as well as generic versions of the pill, became available in the private sector and at selected government clinics to high risk groups. 

But daily adherence to the pill has often proven a problem in studies, particularly among young women. How often you use it impacts on how effective the pill is – the less often Truvada is taken, the less protection against HIV it provides.

The new evidence from the HPTN 083 study now provides an option that may, for some people, be easier to adhere to. “We know some people find it difficult to take pills and the long-acting cabotegravir infections provide them with a choice of product that doesn’t require daily adherence,” explains the study’s chief author, Raphael Landovitz.

“Although Truvada is also an excellent choice of PrEP, it might not be the best choice for everyone. Or the right choice for the same person at different stages of their life.” Sexually transmitted infections — an indication of low condom use and relatively risky sexual behaviour – was common among participants at the start of the study: 5.3% of participants had syphilis, 6.5% rectal gonorrhea and 11% had chlamydia.  “This was a very elevated risk population by design and by demographic.

Yet both arms [the Truvada and long-acting cabotegravir injection arm] had dramatically low incidence rates of HIV infection,” Landovitz says. “So both Truvada and cabotegravir would be expected to work extremely well to reduce HIV incidence.” 

The incidence rate of the cabotegravir group was 0.41% (13 HIV infections over the course of the trial) per 100 person years and 1.22% (39 HIV infections over the course of the trial) in the Truvada group. In easy speak: three times more individuals in the Truvada group got infected compared to the cabotegravir group. 

These results meet the statistical criteria for superiority of two-monthly cabotegravir infections to Truvada. Injectable cabotegravir is also being tested among women in Southern Africa – with sites in Cape Town, Johannesburg and Durban – and preliminary results of the HPTN 084 trial are expected around November.

Needs approval

The long-acting injection needs to be approved by the United States Food and Drug Administration before it can become widely available. 

“We have no idea what the price for an injection would be, but we need to make sure that it doesn’t cost more than oral PrEP,” says Mitchell Warren from the New York-based HIV advocacy organisation, Avac. “A year’s supply of oral PrEP in South Africa costs about $54 [R923] in the public sector, which is actually pretty inexpensive.”

In the private sector, a month’s supply of HIV prevention pills can be bought for between R200 and R300 – that excludes the costs of regular HIV tests and lab tests to make sure the drugs don’t have adverse effects. South Africa’s national HIV plan aims to provide just over 104 000 new users from high-risk groups – such as sex workers, injecting drug users, men who have sex with men and young women — with PrEP by 2022.But the country’s uptake of PrEP has been slow. 

According to Avac’s international PrEP tracker, PrEP Watch, between 44 000 and 45 000 people in South Africa  currently use oral PrEP.   Some of the reasons people have stated in studies for not using PrEP is that they don’t see themselves as being at risk of HIV infection, that it’s stigmatised and that the pills are not easily available.

Warren says: “If we can’t deliver PrEP to people, it doesn’t matter how fabulous it is, it’s useless. And that’s been our problem in PrEP programmes. We’ve gotten too focused on the product that we haven’t invested in how to get it to people.”Warren argues countries, including South Africa, need to take PrEP delivery outside of medical settings.

“Ideally, we’d like to be in a place where community health workers could go from home to home with prevention options, of which one is oral or injectable PrEP, and that the worker can give an injection to clients. We need to task shift and task share. In South Africa, he says, we can learn from the social marketing of condoms in the 90s.

“It wasn’t about making condoms available in pharmacies. It was about spaza shops, the shebeens and other community settings. We need to deliver health products to where and when people want them.”


AIDS 2020: Researchers describe a possible case of HIV remission and a new method to prevent infection


(CNN)There were two notable announcements in the fight against HIV this week at AIDS 2020, the 23rd International AIDS Conference — a possible case of long-term remission from the virus, and research that found an injection can prevent HIV.

Scientists presenting at the conference said a Brazilian man might be the first person to experience long-term HIV remission after being treated with only an antiviral drug regimen — not stem cell transplantation. He had been diagnosed with HIV, the human immunodeficiency virus that causes AIDS, eight years ago and now shows no sign of the virus, scientists said. However, the finding involved only one patient and the research has not yet been published.

Since the AIDS epidemic began in the 1980s, just two people have been cleared of the HIV virus long-term with stem cell transplants. The stem cell treatment for HIV is complicated, risky, and can leave people vulnerable to infection, studies have found. And it may not work because the body can reject the transplant.

In the case discussed by researchers from the Federal University of Sao Paulo, the man — who was 34 years old at the start of the study — was among 30 participants from a clinical trial investigating treatment approaches with the hope of possibly finding a cure for HIV.

he man, who enrolled in the trial in 2016, was 1 of 5 given a “highly intensified” antiretroviral therapy with the drugs dolutegravir and maraviroc and 500mg twice daily of nicotinamide, a form of vitamin B3, for 48 weeks.

In the trial, the researchers monitored and measured viral DNA that could be detected in each participant. The researchers noted that the man interrupted his treatment in March 2019 and he was tested for viral DNA every three weeks after for up to 57 weeks. By 57 weeks, the researchers found his total HIV DNA “was undetectable” and his HIV antibody test remained negative, according to the study.

Although still an isolated case, this might represent the first long-term HIV remission without myeloablation/stem cell transplantation,” the researchers wrote in the abstract. “Further analyses such as viral cultivation and sequential HIV antibody profile/detection are ongoing.”

The study has several limitations, including that this is just one person — more research is needed to determine whether there would be similar findings in others undergoing the same treatment and more research will be needed to see how long remission could continue. Also, even though the man was diagnosed with HIV in 2012, it’s unclear how long he had been infected with the virus and when exactly infection occurred.


Community-based approaches to HIV prevention that address antigay stigma


School-based interventions, social marketing on family acceptance and community connectedness

Despite 3 decades of advances in HIV testing technologies and medications, HIV continues to burden gay and bisexual men disproportionately, especially within communities of color in the United States. One key structural driver of vulnerability to HIV infection is antigay stigma. To counter the detrimental effects of pervasive antigay stigma, widespread implementation of innovative and replicable HIV prevention interventions that affirm and cultivate the healthy formation of gay identities is strongly needed. This article outlines current community-based HIV prevention approaches addressing antigay stigma being used in the field, often with little or no funding.

LGBT-affirming school-based interventions

Antigay bias is rampant in schools and in urgent need of redress. Several studies show that lesbian, gay, bisexual and transgender (LGBT) youth experience higher rates of harassment and violence from their peers because of their actual or assumed sexual orientation (Bontempo & D’Augelli, 2002; Espelage, Aragon, Birkett, & Koenig, 2008; Swearer, Turner, Givens, & Pollack, 2008; Rivers, 2004). Many LGBT students feel unsafe at school and report higher rates of social isolation, depression, suicidal ideation and unprotected sex (Russell, Ryan, Toomey, Diaz, & Sanchez, 2011).

A number of school-based, LGBT-affirming and antibullying interventions are emerging across the country. One such program is the Gay Straight Alliance (GSA). GSAs are support groups where LGBT students, those questioning their sexual orientation or gender identity, and their straight friends can gather to discuss issues associated with their sexual orientation or gender identity and foster communication with others (Ginsberg, 1999). Currently, 4,000 GSAs are registered throughout the United States. The spate of suicides that occurred in late 2010 among gay men who were victims of anti-gay harassment and bullying underscores the importance of GSAs. Research shows that these interventions are a key resiliency factor for gay youth; young gay and bisexual men in schools with pro-gay interventions report fewer risky behaviors associated with HIV transmission, including unprotected sex (Goodenow, 2007).

One study in Salt Lake City found that students’ academic performance improved, their sense of belonging to the school community was enhanced, and their school attendance increased if they were involved with the GSA (Lee, 2002). Replicating programs such as these is critical to preventing the development of risk behaviors that increase vulnerability to HIV among young gay and bisexual men and transgender women.

Social marketing campaigns promoting family acceptance of gay sons and challenging antigay stigma

Family acceptance of LGBT persons is also central to addressing HIV. Research shows that the greater the extent to which one experiences family rejection because of one’s sexuality during adolescence, the poorer the health outcomes for LGBT young adults (Ryan, Huebner, & Sanchez, 2009). In addition to exhibiting higher rates of substance use, depression, and attempted suicide, participants in the study who were rejected by their families were 3.4 times more likely to report having engaged in unprotected sexual intercourse, compared with peers who reported little to no experiences of family rejection (Ryan et al., 2009).

Gay Men’s Health Crisis (GMHC) has implemented a series of social marketing campaigns that draw on a strength-based intervention model. Strength-based campaigns are effective in changing an individual’s behavior (Detweiler, Bedell, Salovey, Pronin, & Rothman, 1999; Devos-Comby & Salovey, 2002; Rothman, Salovey, Antone, Keough, & Martin, 1993). One 2008 campaign, titled “My Son Is My Life,” models behavior in which a Black father supports his gay son. Informational palm cards and ads in print media and in bus shelters highlight reactions parents can have when they learn their son is gay and illustrate steps they can take to provide support and love. “I know he is gay, and I don’t always understand, but that doesn’t change my love for him,” the image reads.

Another campaign, titled “I Love My Boo,” depicts young Black and Latino men in loving, affectionate embraces in public settings — a portrayal of gay men of color rarely seen in mainstream media. “We’re about trust, respect and commitment,” the image reads. “We’re PROUD of who we are and how we LOVE.” The campaign ran in 1,000 subway trains and 150 subway stations in New York City in 2010 to promote positive, strength-based images of Black and Latino gay men, encourage gay men to aspire to committed, long-term relationships, and counter antigay stigma.

A 2008 campaign titled “I know my rights… Do you?” focuses on combatting the stigma transgender women experience in public accommodations by explaining a New York City nondiscrimination ordinance passed in 2002 covering gender identity. Palm cards addressed access to health care, homeless shelters and employment. Research to date on public health issues affecting men who have sex with men (MSM) has largely neglected transgender persons. There are no national data on transgender women and HIV. However, independent studies report that transgender women are among the most vulnerable to HIV infection (Clements-Nolle, Marx, Guzman, & Katz, 2001). Addressing HIV among transgender women requires better surveillance and culturally competent and effective HIV prevention campaigns.

Community connectedness

Community connectedness has also been proven to protect against HIV infection. Greater community involvement counters the negative effects of antigay bias on safer sex practices among gay men by providing social support, enhancing feelings of self-efficacy and positive self-identity, and reinforcing peer norms supporting safer sex practices (Ramirez-Valles, 2002). Greater emphasis on prevention among older adults is also necessary. The Centers for Disease Control and Prevention (CDC) reports that most new infections among white gay and bisexual men occur among those who are 30-49 years of age (CDC, 2008). In 2007, 16 percent of new HIV infections were among people 50 and older (CDC, 2007). Evidence suggests that in addition to experiencing anti-gay bias, older gay men also experience issues related to aging and self-esteem. Some older gay men experience aging differently than their heterosexual counterparts, a concept referred to as “accelerated aging” (Rosario, Schrimshaw, Hunter, & Braun, 2006). This experience of feeling older at an earlier age than one’s chronological age presents issues of social isolation for gay men over 40 who are single and equate physical attractiveness with youth. These men may put themselves at risk for HIV by meeting anonymous partners on the Internet and coupling these experiences with substance use.

Identifying the need for HIV prevention among older gay men in 2008, the Fenway Institute in Boston piloted a group intervention to reduce HIV sexual risk, depression-related withdrawal, and anxiety-related social avoidance in gay and bisexual men 40 and older. The intervention, titled “40 and Forward,” was a series of 2-hour weekly sessions that brought together groups of gay men, ranging from 49 to 71 years of age and of multiple races, to socialize and discuss topics like safer sex. Men who participated in the intervention reported a significant decrease in depressive symptoms, as well as a significant increase in condom use self-efficacy (Reisner et al., 2010). It is notable that the intervention also helped socially isolated older gay men develop social support networks, a critical resiliency factor against HIV.

International efforts

Globally, public health specialists are also recognizing the importance of combatting antigay bias to stem the spread of HIV, especially among MSM. The full scope of the global HIV pandemic among MSM is unclear, as most countries fail to gather surveillance data for MSM. However, evidence suggests that the 86 countries which criminalize homosexuality render MSM highly vulnerable to HIV infection because they are forced underground and face multiple barriers to HIV prevention and treatment (amfAR, 2008). In many African countries, the exclusively heterosexual content of HIV prevention campaigns causes gay and bisexual men to think they are not at risk for HIV. A number of studies show a disproportionate impact of HIV on MSM in sub-Saharan Africa (Beyrer, 2008; Saavedra, zazola- Licea, & Beyrer, 2008). One study reported that in middle-and lower-income countries, MSM are 19 times more likely to contract HIV than the general population (Baral, Sifakis, Cleghorn, & Beyrer, 2007).

In 2008, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) was reauthorized and included language calling for prevention with MSM and research to understand the impact of HIV on MSM. Also in 2008, the former presidents of Zambia and Mozambique, chairing the United Nations’ Economic Commission for Africa, issued a report calling for HIV prevention with MSM and opposing legal discrimination against them. The Global Fund for HIV, Tuberculosis and Malaria is also promoting MSM concerns. In May 2011, the U.S. Office of the Global AIDS Coordinator issued field guidance on MSM (see U.S. President’s Emergency Plan for AIDS Relief, 2011). The guidance gives suggestions for providing HIV prevention to MSM in Africa, the Caribbean, and elsewhere.

Doctors say experimental treatment may have rid man of HIV

A Brazilian man infected with the AIDS virus has shown no sign of it for more than a year since he stopped HIV medicines after an intense experimental drug therapy aimed at purging hidden, dormant virus from his body, doctors reported Tuesday.

The case needs independent verification and it’s way too soon to speculate about a possible cure, scientists cautioned.

“These are exciting findings but they’re very preliminary,” said Dr. Monica Gandhi, an AIDS specialist at the University of California, San Francisco. “This has happened to one person, and one person only,” and it didn’t succeed in four others given the same treatment, she said.

Another UCSF specialist, Dr. Steven Deeks, said: “This is not a cure,” just an interesting case that merits more study.

The case was described at an AIDS conference where researchers also disclosed an important prevention advance: A shot of an experimental medicine every two months worked better than daily Truvada pills to help keep uninfected gay men from catching HIV from an infected sex partner. Hundreds of thousands of people take these “pre-exposure prevention” pills now and the shot could give a new option, almost like a temporary vaccine.

If the Brazil man’s case is confirmed, it would be the first time HIV has been eliminated in an adult without a bone marrow or stem cell transplant. Independent experts want to see whether his remission lasts and for the intense drug combination that he received to undergo more testing.

“I’m very moved because it’s something that millions of people want,” said the 35-year-old man, whose spoke to The Associated Press on condition that his name not be published. “It’s a gift of life, a second chance to live.”

Transplants are how two other men, nicknamed the Berlin and London patients for where they were treated, were cured previously.

“I’m the living proof it’s possible to be cured,” Adam Castillejo, the London patient, said in a news conference at the AIDS meeting, which is being held online because of the coronavirus pandemic.

He and the Berlin patient, Timothy Ray Brown, had donors with a gene that confers natural immunity to HIV infection. Such transplants are too medically risky and impractical to attempt on a large scale, so doctors have been trying other approaches.


Covid-19 may lead to spike in Aids deaths, warns UNAIDS


Six months more of disruptions related to the Covid-19 pandemic could potentially result in a spike of an additional 500 000 Aids-related deaths in sub-Saharan Africa by the end of next year. 

Speaking at the launch of the 2020 UNAIDS Global Aids Update yesterday (Monday), executive director Winnie Byanyima said the agency’s modelling shows that a continuation of severe disruptions from Covid-19 response measures has the potential to push up the Aids death rate by devastating numbers. It’s a scenario that would amount to a 72% increase on the estimated 690 000 HIV-related deaths globally in 2019.

The “alarming figures” from the UN’s monitoring and modelling, Byanyima said, are as a result of access to treatment and prevention programmes for HIV/Aids falling through the cracks as the world’s attention has this year been almost singularly focused on fighting the coronavirus pandemic. 

“If disruptions remain so severe for another six months, we could also see a reversal in mother-to-child transmission that will take us back to 10 years ago,” she said. 

“Our report shows that Covid is a disease that is threatening to throw us more off-course; it is claiming resources like labs, scientists, healthcare workers away from HIV work. We are saying that we need to find creative ways to fight both of these diseases at the same time,” she said, speaking on a webinar in Geneva.

Key UNAIDS targets will be missed

The executive director confirmed that the world will fall short of the 2020 target to have 90% of all people living with HIV know their status; 90% of people with diagnosed HIV infection to be on antiretroviral (ARV) therapy; and for 90% of all people receiving ARV therapy to have achieved viral suppression.

The missed 2020 target comes against the backdrop of more intersecting crises brought on by the Coronavirus. “We know that girls were not safe at home with the lockdown. Violence increased and we know that violence is linked to higher infections among women and girls,” Byanyima said. 

Covid-19 has also impacted drug manufacturing and distribution. The world has witnessed what Byanyima slammed as a “profit over lives” agenda as some companies have looked to cash in on the global crisis by diverting manufacturing capabilities and resources to the Covid emergency only to maximise returns.

“Any epidemic thrives on inequalities, and unless you target these inequalities, you only will make the situation worse for the most vulnerable groups,” she said.  Byanyima pointed to some solutions and strategies to bring the world back on track for the target of eradicating HIV by 2030. 

Debt relief essential

A starting point, she said, is for the HIV/Aids epidemic to be seen not as a health issue, but a human rights issue. 

“Rights matter; we need to stop stigmatising and criminalising. Some of the world’s vulnerable groups of gay men, sex workers, people who use drugs, transgender people, those in prisons and migrants cannot be left behind without access to services and then end up continuing to transmit the disease,” she said.

Communities also need to be at the centre of the fight, she said, as grassroots campaigns can drive behavioural change. She said longer-term debt relief for developing countries is essential too, and so is better tax compliance from companies that should pay their dues to ensure there is money for health responses. 

“We need to keep fighting the inequalities between girls and boys and men and women. We know there are millions of girl children who will not return to school after this pandemic and this is one of the structural barriers in society that need resolution,” she said. 

Treatment gap of over 12 million

The UNAIDS report, titled  “Seizing the Moment – tackling entrenched inequalities to end epidemics” contained updated epidemiological estimates for the world, various regions and countries.

There were an estimated 1.7 million new HIV infections around the world in 2019. “Not acceptable” is what Byanyima called this number as it is three times higher than the target of no more than 500 000 new cases per year.  An estimated 38 million people around the world are estimated to have been living with HIV in 2019. Of these, 25.4 million are on antiretroviral therapy and 12.6 million are not. Antiretroviral therapy is recommended for all people living with HIV.

The report acknowledges that the introduction of dolutegravir-based treatment  combinations as first-line treatment in some countries is a significant advance. Dolutegravir is a still relatively new antiretroviral medicine that has very few side effects, and resistance to it is very rare.

Annual HIV-related deaths have dropped from about 770 000 in 2018 to 690 000 in 2019, but 95 000 of these deaths are of children and teens and the total is still 190 000 more deaths than the UNAIDS 2020 target of no more than 500 000 deaths. It is also estimated that only 53% of children in the world living with HIV receive treatment.  

Progress in Africa

In Africa, it is estimated that there are still 4 500 girls or young women who become infected with HIV every week. This even as sub-Saharan Africa, which has the highest HIV burden, reflected the best progress with new infection rates down by 38% over ten years. 

South Africa’s neighbour, Eswatini, has reportedly surpassed the 2020 goal as of the end of 2019 achieving a 95-95-95 milestone.  Also on track on the continent are Namibia, Botswana, Rwanda, Uganda, Zambia and Zimbabwe, according to the report.

While infection rates are coming down in Sub-Saharan Africa, they are going up in Eastern Europe and Central Asia, and to a lesser degree in the Middle East and North Africa. Another key concern has been a drop in funding and investment to the HIV/Aids-response. Byanyima said there is currently a $7.6 billion (R130 billion) gap in funding globally and a 7% drop between 2017 and 2019. 

That South Africa is almost self-sufficient in funding its national Aids response programme is a resource allocation that Byanyima lauded. She warned that the temptation to divert funding from a priority like HIV/Aids to COVID-19 would invite dire future consequences for any country.

Byanyima said despite the setbacks reflected in this year’s report, there is progress to build on. “There is much to do to remove the structural barriers, but we have made huge progress globally. We have treatments that make HIV a manageable disease; we also have prevention programmes. And with innovation and more technology we can bring the science to meet people where they are so we can start to reach everyone and so that those with the weakest rights do not remain our most silent.”


Confronting missed targets, HIV/AIDS experts emphasize drug delivery


The conversation at AIDS 2020 is focusing not just on developing new technologies to fight HIV/AIDS — but also ensuring the tools that already exist realize their potential for impact.

As the world falls short of 2020 targets for progress on HIV/AIDS, global health experts are highlighting the need to make testing, prevention, and treatment affordable and accessible.

Their insights on ways to close the gap between innovation and uptake for HIV/AIDS hold important lessons for a range of global health priorities where work on research and development is not paired with a plan for delivery, said Mitchell Warren, executive director at AVAC, a nonprofit focused on HIV prevention. 

“We really need to talk about R&D&D,” he said, referencing a shorthand he often uses to capture research and development and delivery.

“Because if we only research and develop but don’t deliver, then frankly the greatest technologies are meaningless, and we see that. A safe and effective vaccine that sits on the shelf for polio is not safe or effective. But we put so much emphasis on new technology that we forget that we need as much if not more innovations in the delivery space. And that’s not for HIV only,” Warren said.

The global health community tends to think about access only after the phase 3 trial, the final stage of clinical research, Warren said. When these studies end early, the donors, implementers, and governments tasked with figuring out access to medicines are often caught unawares.

On Tuesday, the AIDS division at the National Institutes of Health announced the superior efficacy of cabotegravir, an investigative injectable drug under development for HIV prevention and treatment, over oral preexposure prophylaxis, or PrEP.

A study on safety and efficacy of cabotegravir in cisgender men who have sex with men and transgender women who have sex with men ended two years earlier than planned, after cabotegravir was found to be highly effective at preventing HIV in this population.

There was not a strong plan in place to roll out oral PrEP after it was approved following clinical trials in 2012. For cabotegravir, a range of partners came together with the support of the Bill & Melinda Gates Foundation to form the Biomedical Prevention Implementation Collaborative, or BioPIC, which has focused since 2018 on translating clinical trial results for HIV prevention into real public health impact.

At AIDS 2020, Helen McDowell, head of governmental affairs and global public health at Viiv Healthcare, presented what she described as “implementation research priorities to support product introduction.”

Some of the research priorities that will help these products reach the most vulnerable populations include evaluating new and existing delivery channels, working on cost-effectiveness, and integrating into test and treat programs.