CROI for the Community

Rob Newells is the newly appointed Executive Director of AIDS Project of the East Bay. He is minister and founder of the the HIV program at Imani Community Church in Oakland and has been an AVAC PxROAR member since 2012. This blog is one in a series written by community scholars who attended CROI 2016.

I have a love-hate relationship with the annual Conference on Retroviruses and Opportunistic Infections (CROI). The 12-hour days of high science can be overwhelming, and even after being deliberate about building down time into my schedule, I still crashed and burned before the end of Day 3. (It took the entire week to adjust to the time difference between East and West coasts, and after the daily 7 am Community Educator Breakfast Updates, I struggled to stay awake and alert for the morning plenary sessions.) But I survived!

There are always major headlines coming out of meetings like CROI. As a biomedical research advocate, my inner nerd gets super-excited about things like Phase 2 study results from MTN 017 (a rectal microbicide study), but at CROI I’m a community educator. I try my best to take off my research nerd hat for a few days and tune my ears to hear what members of my community will find useful right now. (I’ll have plenty of time and dozens of webinars to help me grasp all of the high-level science presented at CROI so that my inner nerd will be ready for additional updates during the International AIDS Conference in July.)

The week after returning to Oakland from Boston, I shared information with the staff working at AIDS Project of the East Bay (APEB) and with community members participating in a series of breakfast discussions coordinated through my ministry at the Imani Community Church in partnership with the East Bay HIV Faith Collaborative. This is what I told them:

  • Vaginal microbicide rings look like they’ll work. Don’t be frightened when you hear that the HIV infection rate was only reduced by about 30 percent. Remember that old 44 percent reduction in the HIV infection rate for pre-exposure prophylaxis (PrEP) when the first iPrEx study results were released just over five years ago? It gets better! With PrEP we saw that when people know the product actually works, they use it more and risk goes down. It works when you use it! Will the same thing hold true for the vaginal ring? There’s a need for open-label studies to see if women will use it more when they know it works.
  • There’s reason to think injectable PrEP might work, but there are questions about how to deal with the “tail” — the period of time after injectable PrEP is terminated but there still may be low (non-protective) levels of drug in the system.
  • People who use oral PrEP are generally people who are already at-risk for STIs, and they should be tested more often than every six months as is currently recommended by the CDC. (Our Medical Director at AIDS Project of the East Bay already screens PrEP clients for STIs quarterly as suggested by the research presented at CROI.)
  • We talked a little about the PrEP failure case from Canada, which occurred when the PrEP user was infected with tenofovir- and emtricitibine-resistant virus. But staff and community members alike were more interested in the HPTN-073 study results showing that, with a little client-centered care coordination (C4), it’s really not so difficult to spark black men’s interest in PrEP. This was the silver lining in the cloud hovering over the community after CDC presented lifetime risk estimates indicating that half of all gay black men in the US will test positive for HIV if we don’t do something about it now. (If my community needed a wake-up call… a new reason for a sense of urgency around this HIV epidemic… a fire lit under its collective ass… This has to be it.)

Then we spent a little time talking about things I heard at CROI that probably won’t make headlines:

  • Do you really understand how much smoking while living with HIV increases risk for opportunistic infections, cardiovascular disease, lung disease and some cancers while decreasing life expectancy? What are we saying to our clients living with HIV about smoking that’s different from what we say to clients not living with HIV? (After checking in with our Medical Director, APEB will be implementing a smoking cessation program through our primary care clinic.)
  • When researchers looked at people’s “Perception of Infectiousness,” the takeaway for me was that black people still don’t believe having an undetectable viral load prevents the transmission of HIV. (There are lots of conversations about medical distrust among African Americans begging to be had over and over and over again until someone figures out how to effectively address the issue.)

Another CROI is in the books (and on webcast). It will likely take months for my inner research advocacy nerd to wrap my head around all of the science, but now that my sleep pattern and weather conditions are closer to California-normal, the community educator in me is very happy.

Context Matters: Key Thoughts from CROI 2016

Josephine Ayankoya works for the San Francisco Department of Health’s Bridge HIV program and is a member of AVAC’s PxROAR program. This blog is one in a series written by community scholars who attended CROI 2016.

Attending the Conference on Retroviruses and Opportunistic Infections (CROI) for the first time was an excellent learning opportunity. In the midst of many of the world’s leading researchers in basic, clinical and translational science, I was excited to be among the first to hear about breaking news in biomedical research. While sitting through sessions, and talking with colleagues, I constantly reflected on what this research meant for my communities. My excitement about the progress in research was matched with a desire to build on the data. With every study that I learned about, I was further inspired to support multidisciplinary approaches to ending the HIV/AIDS epidemic.

This is why I found Dr. Gerald Friedland’s N’Galy-Mann Lecture on confronting HIV and tuberculosis in New York and South Africa to be incredibly encouraging. As Dr. Friedland spoke on his experience working with under-resourced, low-income communities of color, he highlighted the importance of understanding the context in which HIV disparities occur. Two quotes stood out to me as he spoke about overlapping epidemics that people at risk for HIV have always juggled. The first was that, “We have to meet marginalized and stigmatized populations where they are and increase resources where they live.” The second was a reminder that, “Declines in HIV have followed eras of activism that led to an increase of political will.”

Meeting underserved communities where they are, increasing resources where they are needed, and increasing political will are easier said than done. It takes sustained commitment, and strategic planning but these actions are possible. More than anything at CROI, I was reminded that data are powerful and should be used as a foundation for civic engagement efforts.

In the United States, Black men who are gay, bisexual, or same-gender-loving (GBSGL) carry a disproportionate burden of the HIV epidemic. For years, the Centers for Disease Control and Prevention (CDC) have reported that while new infection rates in most populations are stable, they are increasing among Black GBSGL men, especially young ones. At CROI, the CDC released data which estimated that throughout the span of their entire lifetimes, half of Black GBSGL men could be infected with the virus. It is a heartbreaking, yet sadly unsurprising, call to action.

As performer, activist Tim’m T. West stated, “It’s easier to blame victims when you can’t talk about systemic racism… when you can’t talk about institutionalized homophobia… Then Black men become responsible for their own dying. In that sense, ‘It’s something they brought upon themselves.’” We cannot talk comprehensively about the disparities among Black GBSGL men without talking about the effects that oppression and under-representation play on their health. It is impossible to fully understand this disparity without acknowledging how the blockage of Medicaid expansion in the Deep South hinders millions of Black people from accessing basic health care. There is a myriad of social, political, economic and cultural barriers that exacerbate HIV disparities.

The socio-cultural context in which Black men, and all African heritage people around the world, live is complicated. Mitigating the multiple challenges that lead to these disparities will take a lot of work. In the words of Dr. Darryl Wheeler, “It’s difficult, but it’s still worth doing.”

Our work as HIV/AIDS researchers, educators and advocates naturally aligns with the work of colleagues in the legal, health, urban planning and educational sectors of society. The people most at risk for HIV are dealing with a series of challenges outside of maintaining their sexual health.

I was thrilled to hear researchers Darryl Wheeler and Sheldon Fields talk about the results of the study HPTN 073 looking at PrEP uptake in Black GBSGL men, because it demonstrated how research can be used to meet marginalized people where they are. The study enrolled over 200 Black gay and bisexual men in three cities across the United States—Atlanta, Chapel Hill and Los Angeles. These men were engaged in a culturally-competent method of counseling called client-centered care coordination (C4). They were also offered access to PrEP. The study found that with C4, the majority of Black GBSGL men decided to initiate and sustain the use of PrEP. Men who attended more of the C4 sessions tended to use PrEP more often than those who attended less of the C4 sessions.

Not only did this research meet people where they were by responding to psychosocial needs that had not been fulfilled, it increased resources for those who need them most. I have known about this study for years, so I was proud of its outcome. It reiterated what many already know: the context in which HIV disparities occur matters.

We will never end the epidemic without strategically working to change public policy. It is critical to use data from studies like HPTN 073 to increase the political will of our elected officials to implement interventions proven to work. To truly address HIV, we’ll have to build and maintain coordinated advocacy movements with coalitions across different sectors of society.

As Dr. Friedland stated the first day of CROI, activism leads to political will and, in turn, the decline in HIV. Our individual and collective actions will determine what this era of HIV research, prevention and treatment will entail. In a time when we have more tools than ever to prevent HIV, no one should be getting infected and every person with HIV should be able to access treatment. I hope now, more than ever, we use evidence-based approaches to advocate for and with communities most at risk for HIV.

Let’s make this era one to remember. Let’s make this the era where data were used to change the many structures that influence HIV/AIDS disparities.

CROI Round-Up; Post-Conference Webinar Series

News last week from the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston was dominated by new efficacy data from two vaginal ring trials that have implications for HIV prevention for women. Our take on it is here, along with a special page with more background than we could squeeze into a blog post. But, the CROI buzz wasn’t all about vaginal rings, and this update provides some ways to hear more about what happened last week and what it all means.

Post-CROI Webinar Series

We will be convening a series of post-CROI webinars covering a range of topics over the next couple of months. The first webinar in our series explored the ring results with advocates and researchers. Slides, audio and the Flash animation of the webinar are available here. And stay tuned for details about the additional webinars in the series!

In-Depth Analysis

In addition to lots of media reports and publications, our colleagues at NAM/aidsmap, The Body and NATAP all provided in-depth coverage of the myriad studies presented in oral abstract sessions, posters and more. Check out the hyperlinks above for comprehensive coverage.

CROI Program and Webcast

CROI provides a number of ways to review what happened in Boston: check out the full program; taped playbacks of press conferences; webcasts of all sessions; and electronic posters will be available a week after the conference. There was a wealth of information on a wide range of topics, but here is a selection of sessions and presentations you might want to explore:

  • Lifetime HIV risk in the US: New data from the US Centers for Disease Control and Prevention (CDC) projected that 1 in 2 black gay men could be diagnosed with HIV in their lifetime. That number is 1 in 4 for Latino gay men and 1 in 49 for African American women. The figures for white men and women are far lower. These data highlight the ways that race impacts access to healthcare at every point in the treatment cascade. They suggest an urgent need to provide prevention including PrEP at a wider scale and with messages and programs that are community-designed and owned. They also provide another opportunity to examine the ways that alarming statistics do and do not advance a structural analysis of the problems and solutions to public health issues. As one article highlighted—individual risk calculations can lay the burden on individuals to change behavior when the drivers of risk are systemic, embedded and often out of individual control.
  • PrEP in the Real-er World: There was a lot of data on oral PrEP that, as expected, added layers to understanding of what the strategy is, and what it can and cannot do. It started with a presentation by Keith Green (University of Chicago) on Engaging Young Men of Color in Community HIV Prevention Studies and later Darrell Wheeler (SUNY Albany) presented an important PrEP study in Black MSM (HPTN 073), which showed that a culturally anchored “client-centered care coordination” model (C4) was important to getting men into and supported in a PrEP program. Other data gave some insight into additional components of PrEP programming and messaging. Presentations included findings that PrEP use can have a limited impact on renal function—as it can in people living with HIV who use TDF/FTC as part of treatment; an update from a New York City PrEP project where rates of sexually transmitted infections among PrEP users suggest that routine screening—at every clinic visit—should be the norm; and finally, a presentation of HIV infection in an adherent PrEP user who acquired TDF/FTC-resistant HIV. Each of these presentations raises concerns—and thebody.com has developed an excellent resource on the HIV-resistance data—but none are insurmountable or even surprising. Piloting PrEP in the real world is the only way to find out how best do deliver, message and monitor this new strategy to all populations at risk.
  • Long-Acting Injectables for Treatment—and Prevention: Antiretrotival treatment options took a step forward with the first injectable treatment option. 91 percent of patients in a study of the 8-week long-acting injectable cabotegravir and rilpivirine combination regimen maintained virological suppression and also expressed satisfaction with this new option in a new study. Both cabotegravir and rilpivirine are also being explored separately as PrEP agents. Marty Markowitz (Aaron Diamond AIDS Research Center) presented results from the Phase IIa ÉCLAIR study that examined the safety and pharmokinetics of cabotegravir in HIV-uninfected men, setting the stage for a future Phase III efficacy trial.
  • Turning Targets into Treatment: A full abstract-driven session was devoted to Getting to 90/90/90 and included Tendani Gaolathe (Botswana Harvard AIDS Institute Partnership) presenting on how Botswana is approaching the 90-90-90 goal, getting to 83 percent (testing), 87 percent (on treatment) and 96 percent (virally suppressed) representing an overall level of viral suppression of 70 percent as compared to the 73 percent goal of the 90-90-90 goals. Factors predictive of not being virally suppressed included youth, male gender, single status and, interestingly, higher education level. At the same time, there was a presentation on how Malawi is using its Option B+ rollout to prepare for universal treatment. The challenges of Option B+ could be seen in the 25 percent drop off in post-partum adherence by women after six months. And in a separate session, Helen Ayles (London School of Hygiene & Tropical Medicine) presented Missing But in Action: Where Are the Men? raising an emerging discussion of how to reach HIV-positive men with treatment programs. Strategies suggested include taking testing outside antenatal clinics and engagement through men’s clubs and even bars. While reaching these men is important, it remains critical that treatment for all who need it remain a focus.
  • Rectal Microbicides Well Received: Ross Cranston (MTN) presented data from MTN 017, the first Phase II rectal microbicide gel study—it showed no safety risk and both adherence and acceptability were high. The open-label trial looked at a rectal formulation of tenofovir gel inserted via vaginal applicator, comparing its daily use with event-driven (used before and after sex) use. A third study regimen included the use of daily oral Truvada as PrEP. All 195 MSM and transgender women cycled through each of the three regimens for eight weeks. Adherence feedback was provided to participants through daily texts, returned applicators and real-time drug levels reporting. This contributed to high adherence across all study regimens. Overall preference favors Truvada as PrEP slightly over event-driven tenofovir gel, but the difference is not statistically significant. Daily gel application came in a close third. Cranston concluded that due to these results, rectal tenofovir gel is worthy of further study. Research is already underway to expand the pipeline of rectal microbicide products in order to find the right product to move forward into an effectiveness study, said Ian McGowan (MTN), co-author of the study.
  • New Cure Work Discussed at CROI: On the day before CROI officially opened, the AIDS Treatment Activists Coalition, AVAC, European AIDS Treatment Group, Project Inform and TAG co-sponsored a community workshop on scientific, regulatory and community engagement issues in HIV cure research, which included an update on an exciting and emerging area using bNAbs for treatment and acute infection in the FRESH (Females Rising through Education, Support, and Health) cohort in South Africa. Presentations are posted online.

Medical Distrust: The Real Reason for PrEP Misgivings in the Black Community

At this year’s National African American MSM Leadership Summit on HIV/AIDS and Other Health Disparities (#NAESM2016), a white doctor stood before a room filled with hundreds of black men at the opening plenary luncheon and talked about how many people “need” to get on PrEP.

I get it. PrEP is the one of the best biomedical prevention tools available to people at risk for HIV infection today. PrEP is safe and effective. PrEP works if you take it correctly. I get it. What I don’t get is why a white doctor would be invited to stand before a room full of black men and tell them that they need to use this medication. The message may be appropriate, but the messenger (and how the message is delivered) matters.

There are lots of barriers to PrEP uptake among black MSM, but beyond the issues of risk perception, healthcare access, provider and consumer PrEP knowledge, PrEP stigma, and homophobia, the elephant in the room is still the history of medical distrust in the African-American community. Distrust of the medical system has been a barrier to care for African Americans since long before the AIDS epidemic started. Black people in the US have the highest mortality rates due to heart disease, diabetes, and some cancers, partially because of our distrust of medical providers. There is also the lingering legacy of mistreatment by researchers—particularly during the Tuskegee Syphilis Experiment—which left black people in the US wary of medical programs and clinical trials.

Medical distrust existed decades prior to the shocking revelations over the 40-year-long Tuskegee study, wherein black men with syphilis were left untreated in order to observe the natural progression of the disease. Dangerous, involuntary and unethical experiments have been carried out on African American subjects at least since the eighteenth century. Accounts of medical and personal violation were passed down orally, from generation to generation. Medical distrust could contribute to the slow uptake of PrEP among black men.

Beyond the importance of both the message and the messenger, we have to recognize that HIV prevention has been medicalized. After 30 years of abstinence, partner reduction, and condoms, we can’t talk about ending HIV today without talking about research and pills and big pharmaceutical companies that make (and charge) ridiculous amounts of money. That looks suspicious as hell to a whole lot of black folks.

Perceptions of greed and racism in routine medical care all contribute to the distrust of physicians. What other people may see as routine medical care is often perceived by African Americans as experimentation, especially when the message is that a certain number of black men “need” to be on PrEP. (Again, how the message is delivered matters.)

And – in the spirit of Black History Month in the era of #BlackLivesMatter – we don’t trust the police (or any part of the criminal justice system). They will pull you over for driving-while-black, beat you off-camera, and say you did it to yourself. We don’t trust politicians (or any part of government). They will have you drinking water from the Flint River as if it were red Kool-Aid. People who have experienced racism or discrimination from individuals or institutions are less willing to be vulnerable and place trust in a system of unknowns such as medical care.

We’ve been beating around the bush. We’ve been picking the low-hanging fruit because issues of medical distrust are too difficult to deal with head-on.

Solutions such as the recruitment of minority healthcare administrators and executives and the presence of Community Advisory Boards that represents the the people help to change the perceptions of African American patients, but we have to do better. Short of a revolution at the polls or in the streets we need to expand support for efforts like AVAC’s PxROAR and the Black AIDS Institute’s African American HIV University, which aim to develop leadership and expertise in the communities most impacted by the epidemic.

There are all kinds of ways to frame it. The GIPA principle recognizes that personal experiences of people living with HIV and AIDS are important in shaping the response; Abraham Lincoln said that government systems should be “of the people, by the people, for the people”; and the name of 90’s American hip hop clothing company FUBU is an acronym for “For Us By Us”. If gay, black men are the group most at-risk for HIV infection in the United States, then they must be allowed to take lead roles in educating our communities about HIV prevention options.

The messenger matters. Gaining the trust of black men in the health care system is imperative if we are to reduce health disparities including incomparable rates of new HIV infections in young, gay black men.

New Px Wire: What to Watch in 2016

There are few, if any, quiet years in HIV prevention research and implementation. 2016 promises to be another year of big deal data, whether it’s findings from clinical trials, funding levels or readouts from PEPFAR’s first year of a geographically focused program plan. We write about this and a lot more to watch for in our new issue of Px Wire.

Click here to download the new issue.

We take a look at the bigger picture in our centerspread. Check it out for the most current version of AVAC’s classic timeline of biomedical HIV prevention research. But don’t get too attached—some of the trials mentioned in the timeline will have updates presented next week at the annual Conference on Retroviruses and Opportunistic Infections. We’ll always have an updated version in our Infographics Gallery—and save the date for a March 1 webinar to discuss the latest data and what’s next?

The full issue of Px Wire, as well as our archive of old issues and information on ordering print copies, can be found at www.avac.org/pxwire.

As always, we welcome your questions and comments at [email protected].

Effectiveness and Adherence in Trials of Oral and Topical Tenofovir-Based Prevention

Trials of oral and topical tenofovir-based PrEP show that these strategies reduce risk of HIV inection if they are used correctly and consistently. Higher adherence is directly linked to greater levels of protection.

UNAIDS Profiles Six PrEP Pioneers, Uncovering Strategies, Concerns, Motivations and More

Succinct yet informative interviews with six leading PrEP advocates highlight the many steps of the process from research to rollout where they are gaining ground. The international group featured in this UNAIDS Community Advocacy Update discusses the history of PrEP advocacy and next steps in translating WHO’s 2015 recommendation of daily oral tenofovir-based PrEP as an option for those at substantial risk of HIV acquisition.

The advocates profiled in the update include Brian Kanyemba of the Desmond Tutu HIV Foundation in South Africa and a 2011 AVAC Fellow; Sally-Jean Shackleton of the Sex Workers Education and Advocacy Taskforce (SWEAT) in South Africa; Midnight Poonkasetwattana of the Asia-Pacific Coalition for Male Sexual Health (APCOM) in Thailand; Bathabile Nyathi from the Centre for Sexual Health & HIV/AIDS Research (CeSHHAR) in Zimbabwe; Pedro Goicochea from Peru and now at the Forum for Collaborative HIV Research; and AVAC Executive Director Mitchell Warren in the United States.

Anatomy of a Target – PrEP

In Px Wire, our quarterly newsletter, we looked at the strengths and limitations of new PEPFAR targets, new UNAIDS targets, new guidelines on ART and PrEP from the WHO and new Sustainable Development Goals.

In this excerpt from our centerspread graphic, we take a closer look at PrEP.

When PrEP Educators Don’t Like PrEP: Minister Rob Newells’ message to naysayers

What do you do when the people responsible for implementing PrEP education programs don’t trust the science? What if the outreach workers and HIV test counselors believe they’re required to “push” PrEP at the expense of behavioral interventions that have been the focus of prevention programs for years? These are people in prime positions to provide PrEP education to key populations, but suggesting that otherwise healthy clients start a daily medication for prevention is a tough pill for some front-line staff to swallow.

I am a black MSM. I serve at a community-based organization where a large percentage of both the clients and employees are black MSM. One of the known barriers to PrEP implementation among black MSM is medical mistrust. Those barriers don’t just exist among clients; they also exist among members of the HIV workforce tasked with increasing PrEP awareness in their communities. If members of the HIV workforce don’t trust the medical establishment or clinical research or pharmaceutical companies or government agencies, how do we expect them to provide unbiased information about PrEP to the people who need it most?

With all of the good work HIV prevention research advocates have done educating the public about PrEP, there has been more than enough misinformation disseminated about PrEP to create and encourage lingering doubt in the minds of those who are already mistrustful of the medicalization of HIV and the perceived influence of pharmaceutical companies on the HIV prevention agenda. After the 2015 National HIV Prevention Conference in Atlanta, I listened to staff members who had attended as they reported back to staff that stayed behind:

  • “There are lots of things we still don’t know.” (Never mind that we know HIV incidence in our Black MSM community is an overall 32 percent, surpassing rates in many populations in sub-Saharan Africa.)
  • “We need more information.” (Never mind clinical trials and real-world evidence showing that PrEP is safe and effective and therefore FDA-approved and WHO-recommended.)
  • “There are still questions about the long-term effects of the drug.” (Never mind that we have more than a decade of experience of Truvada in people who are HIV positive.)
  • “People who take PrEP stop using condoms, and STI rates are increasing.” (Never mind the fact that STI rates started increasing before most people had even heard of PrEP. Furthermore, CDC PrEP protocol recommends STI screening, and treatment if necessary, every three months.)

So what do we do when the people responsible for implementing PrEP education programs don’t trust the science?

If I could talk to all of the PrEP-hater educators, I’d tell them that I wish Truvada had been available for HIV prevention when I was treated for syphilis in 2003. It took several months to get to a syphilis diagnosis because I was treated for a skin rash and gout and had a sigmoidoscopy (an invasive large-intestine probe) before the doctor even ordered an HIV test. (This was before rapid testing was widely available, so I had to think about all of my risky behaviors for a couple of weeks before I got the call that the test was negative.) It was the only time I had ever been worried about HIV infection. It took a while longer before the doctor ordered an STI screening, discovered the syphilis, and ordered the appropriate treatment.

After dodging that bullet, I would have jumped at the chance to protect myself from HIV infection by taking a pill every day. I was in my early thirties; I was a personal fitness trainer in Washington, DC with a good day job; and I had a fairly active sex life. Sometimes I used condoms. Sometimes I didn’t. I had never had any concerns before, but that syphilis scared the hell out of me. It didn’t scare me after I found out what it was because syphilis is totally treatable. It scared me when I thought that I might have been infected with HIV. (It didn’t, however, scare me enough to make me increase my condom use to 100 percent consistently and correctly.) If a pill a day could take the worry of HIV infection from me, I would have been all for it. I wouldn’t have been concerned about long-term side effects or toxicities. I was concerned about living.

If Truvada had been available as PrEP when I tested positive for syphilis in 2003, I probably wouldn’t have tested positive for HIV in 2005. The silver lining is that PrEP is available now. There are black MSM now – who like me then – would jump at the chance to protect themselves from HIV infection by taking one pill every day during their season of risk if they could have accurate, unbiased information about PrEP.

To all of the people responsible for implementing and educating communities about PrEP who don’t like PrEP, I say, “It’s not about you.” Your questions have been asked and answered. PrEP works (and is safe and effective) when it is taken according to the prescribing guidelines. Don’t let your personal or professional biases and misinformation become a barrier to key populations like black MSM accessing an HIV prevention option that might be right for them. PrEP is not appropriate for everybody, but everybody needs to know about PrEP. Get out of the way.

Rob Newells is the newly appointed Executive Director of AIDS Project of the East Bay; he is minister and founder of the the HIV program at Imani Community Church in Oakland and is a PxROAR member since 2012.

South Africa and Kenya Approval of Oral PrEP Should Spur Rollout

Less than a month after South Africa’s national regulatory authority, the Medicines Control Council, approved tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, or trade name Truvada) for PrEP, Kenya took the same step. The country’s Pharmacy and Poisons Board (PPB)—the regulatory body that considers new drugs—also approved TDF/FTC for PrEP for adults at high risk of sexually acquiring HIV-1 infection.

Notably, the PPB made this decision within 30 days of receiving a submission from Gilead, the drug’s manufacturer. This swift approval sets a strong precedent for other countries and should spur other countries and global health organizations to quickly follow suit.

Both countries’ approvals of TDF/FTC as PrEP is the capstone on a transformational year for PrEP. The French Ministry of Health granted provisional approval of TDF/FTC as PrEP in November; the World Health Organization recommended PrEP as an additional prevention option for all people at substantial risk of HIV infection worldwide in September; and the PEPFAR Scientific Advisory Board recommended swift integration of PrEP into comprehensive HIV prevention programs in PEPFAR countries. This October recommendation came with a particular focus on young women at high risk as well as gay men and other men who have sex with men, and recommended steps to overcome regulatory barriers in countries where PrEP is not yet approved.

Daily oral PrEP is finally beginning to take its place as a core element of global HIV prevention.

But PrEP rollout is still happening far too slowly for millions of women and men at risk for HIV. Other countries need to follow the leadership of Kenya and South Africa and find ways to deliver this life-saving option today.

Young women, especially, are in desperate need of new prevention options they can control. While regulatory approval in these two countries should help accelerate access to oral PrEP, additional work is needed to ensure that millions of women, and men, from across the globe are able to benefit from a breakthrough that was developed expressly for them.

To elevate this from rhetoric to on-the-ground access and impact, a coordinated, global push to secure additional regulatory approvals, mobilize funding, raise awareness, generate demand and establish systems to get PrEP into the hands of all people most likely to benefit is needed. South Africa and Kenya’s experiences may offer a model for other nations, but there is no reason to wait. PEPFAR, the Global Fund and other key stakeholders (including Gilead Sciences and the generic manufacturers of TDF/FTC) should be working with countries to break down barriers to PrEP access within the next year.

For more information: