Science, Solutions and Questions at Vancouver IAS Conference

“Science has delivered solutions. The question is: When will we put it into practice?”

So says the last line of the Vancouver Consensus Statement, a stirring call for expanding access to antiretrovirals for treatment and prevention as part of a comprehensive response to AIDS. AVAC signed the statement, released at the start of this year’s conference of the International AIDS Society. So did virtually every notable scientist and physician in the field. And we firmly believe in the contents of the statement.

Over Sunday and Monday pre-conference satellite sessions and in the official program, we heard a lot of science. On Monday, there were presentations of data from HPTN 052 and START—two complementary trials of ART in people living with HIV. There were also data from the ADAPT and IPERGAY PrEP trials and a press conference looking ahead to news from later this week.

For all of this, the Vancouver Consensus Statement is the backdrop—as is the news, released by UNAIDS just prior to the launch of the conference, that the global total of people initiated on ART has exceeded 15 million, and that incidence has begun to drop in some places.

Overall, it is a very good time to be on the side of scientific solutions to the HIV pandemic. And that’s where AVAC stands. But listening closely at the conference and in recent months, we’d offer this additional formulation of the consensus statement’s closing line: “Science has delivered the questions. The solution is: Not shying away from the answers.”

One of the primary solutions that science has delivered is the use of antiretroviral therapy for people living with HIV, both for their own health and to reduce the risk of onward transmission. In a special presentation on Monday (The Strategic Timing of Anti-Retroviral Treatment (START) Study: Results and Their Implications (Monday 20 July, 11:00-12:30), Jens Lundgren (University of Copenhagen) presented data from the START trial, which showed significant benefits for people living with HIV who started ART regardless of CD4 cell count, versus those who started treatment as indicated by the guidelines where they lived. As described in May, when data from the study were first reported, immediate initiation more than halved the risk of serious adverse events, serious non-AIDS events, or deaths.

This is the first major meeting since the START data started making waves (between START and PrEP, this may be the most pun-able conference to date), reaffirming global campaigns to expand ART coverage and to make ART the cornerstone of efforts to end AIDS.

If START has a twin, it is HPTN 052, which also saw data presented on Monday. Mike Cohen (UNC and HIV Prevention Trials Network) delivered the complete findings from HPTN 052, which first reported interim results in 2011 (View slides and abstract via the Conference Programme, session MOAC01: TasP: Just Do It. Monday 20 July, 11:00–12:30)

In that preliminary report, immediate initiation of ART (in this trial, at CD4 cell counts above 350) dramatically reduced the chances that an individual would pass HIV to his or her primary partner.

In the data Cohen presented here, the initial finding holds true. Over the course of the trial, there were eight “linked” transmission events (where the virus acquired matched that of the partner enrolled in the study) in couples where the HIV-positive partner had initiatied ART. Where transmission did occur, it usually happened in the context of incomplete virologic suppression—either a person had started ART too recently to be completely suppressed or because of adherence challenges.

The bottom line: virologic suppression makes HIV transmission between individuals where one person is living with HIV and the other is not highly unlikely. The treatment that has a prevention benefit is also good for the individual—so on every count, the science appears to have provided the solution.

And yet. The real world is a decidedly unscientific place.

In HPTN 052, there were 26 unlinked transmission events, where a person with a known HIV-positive partner acquired HIV from outside the primary partnership followed in the study. So having one partner who is virologically suppressed isn’t protective for an HIV-negative person who, for a variety of reasons, may have other partners and/or other sources of risk, such as injection drug use.

This reality is one of the many places where science and social, cultural and personal realities demand multiple solutions. The number of unlinked cases of HIV is a reminder that people exist in complex realities, with multiple partners and various behaviors.

Another powerful reminder of this context came at a pre-conference satellite on the global status of women’s access to ART. That session presented preliminary findings from an ongoing investigation commissioned by UN Women and carried out in collaboration with the ATHENA Network, Salamander Trust and AVAC. Combining a participatory methodology in which women living with HIV defined, delivered and assessed questions about health care experiences and an in-depth literature review, the work to date shows that women are being reached by ART but that the rights-based framework that allows them to remain on ART after initiation is, in many instances, lacking.

What to do with these data?

One answer does lies in science. Earlier this year, at the Conference on Retroviruses and Opportunistic Infections, the investigators of the Partners Demonstration Project presented the results of their combination PrEP and treatment study in which the HIV-negative member of a serodiscordant couples was offered PrEP as a “bridge to ART” for the person living with HIV. Right now, the data say that PrEP reduces risk of HIV acquisition regardless of who your partner is or how many partners you have (for more on PrEP, see below). And it turned out that, over the course of the study, very few new cases of HIV occurred. For 48 percent of the time, couples were using PrEP alone. PrEP and ART overlapped during 27% of the time, ART was used alone 16% of the time, and neither was used 9% of the time.

WHO did not formally publish their new ARV guidelines at this meeting. However, Gottfried Hirnschall, who directs WHO’s HIV department, did say that additional formal guidance on both PrEP and ART would be released by the end of the year. It is even possible that “rapid advice” could be available sooner—perhaps even in a matter of weeks. Hirnschall anticipated that these new ARV guidelines would recommend the offer of treatment for all adults and adolescents regardless of CD4 count as well as PrEP being offered as an additional prevention choice for people at substantial risk of HIV infection.

As Ambassador Debbi Birx, head of the US PEPFAR program stated in her Monday morning plenary, “Don’t wait for the paper” from WHO or other agencies. “Act on the science and evidence now.”

Acting on science is, as Ambassador Birx and other speakers have noted, just part of the solution. Success depends on non-scientific solutions that are, in some cases, getting lip-service but struggling for real traction today. Women in the global survey described above consistently reported the benefit of peer-delivered treatment literacy, non-stigmatizing sexual and reproductive health care, and rights-based care for all women, including those who aren’t pregnant when they enter the health system.

The science, if we really listen, says something slightly different. It says that ART for people living with HIV and PrEP for people who are at risk, and peer-delivered treatment literacy, and rights-based health care environments for women, men, young people and all key populations can begin to end the epidemic—if and only if other strategies are scaled up at the same time.

PrEP Talk: Promising, Perplexing
Monday was also a big day for PrEP data (slides can be downloaded from the session MOAC03 from the online conference programme), with data from the ADAPT trial that evaluated various dosing strategies, including once-daily, fixed intermittent dosing and event-driven dosing. The study enrolled South African women and gay men and transwomen in Thailand and the US. Overall, people were able to take PrEP, reported principal investigator Bob Grant. Individuals who were counseled to take the drug on a daily basis had a higher coverage of sex acts than those who were advised to use a non-daily strategy. For this group, the missed dose was usually post-sex—a finding that echoes reports from women who participated in the FACTS 001 trial of 1% tenofovir gel, which also tested a coitally-related dosing schedule. In both ADAPT and FACTS 001 cases, the dose after sex proved difficult—participants weren’t at home and/or weren’t in the emotional or physical space where they felt they could swallow a pill or insert a gel.

The good news from ADAPT is that PrEP continues to be feasible and acceptable in a variety of settings and demographics—bolstering the call for this strategy to be rolled out as an additional prevention option for all individuals at high risk.

Of concern and for careful tracking by advocates, is messages coming from the podium that PrEP may not work as well for women as it does for men whose primary risk is via anal sex. It is clear that women need to take daily oral PrEP for longer periods of time before they have protective levels in their vaginal tissue. It is also clear that adhering to a daily oral regimen may be difficult for some women, just as it is for some men. But what’s happened over the past few days with casual references from NIAID Director Tony Fauci and other leading scientists is a sowing of confusion that appears to contradict the US FDA recommendation and data from the Partners PrEP and TDF2 trials that found comparable protection for men and women.

Sometimes science raises questions, and we’re all for these questions coming to light. But it’s essential that the language be clear and that the way to certainty be mapped out. Right now, the discussion feels more risky than scientific—at a time when science is supposed to reign.

New Report on HIV Prevention R&D Investment Highlights 2014 Global Funding Trends

The recent UN Report on the Millennium Development Goals (MDGs) calls out the 40 percent reduction in new HIV infections since the MDGs were established in 2000 as a singular MDG achievement1. That progress reflects 15 years of HIV research in many forms—from female condoms and voluntary medical male circumcision, to new strategies for preventing vertical transmission to the scale-up of ART. Over the years, this progress has been supported by investments from many government, philanthropic and private sector funders of HIV prevention research.

The 11th annual report on the state of HIV prevention research investment, HIV Prevention Research & Development Funding Trends 2000–2014: Investment Priorities To Fund Innovation In An Evolving Global Health and Development Landscape, suggests that this work is still on the agenda for funders, albeit with a small cohort supplying the bulk of the resources.

The new report, released in Vancouver at the IAS 2015 conference, was prepared by the HIV Vaccines & Microbicides Resource Tracking Working Group (RTWG), led by AVAC, in partnership with the International AIDS Vaccine Initiative and UNAIDS. HIV Prevention Research & Development Funding Trends 2000–2014: Investment Priorities To Fund Innovation In An Evolving Global Health and Development Landscape documents that absolute funding levels have been stable over the past few years. This reflects an overall decline in real spending given biomedical research inflation.

In 2014 funders invested a total of US$1.25 billion in research and development (R&D) for HIV prevention—representing a decrease from the 2013 funding level which totaled US$1.26 billion.

In 2014, the US public-sector and the Bill & Melinda Gates Foundation account for 83 percent of all HIV prevention R&D funding and the number of philanthropic funders engaged in HIV prevention research has continued a steadily decline since 2010. Thus, the report points to the need for a broader funding base.

Despite the slight decline in funding, HIV prevention R&D is still delivering important advances. The 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver July 20-22, will showcase results for a range of groundbreaking research that has been supported over the past several years, including the Strategic Timing of Antiretroviral Treatment (START) trial, the HPTN 052 treatment as prevention trial and several groundbreaking oral PrEP trials.

Results from studies of a vaginal ring containing the antiretroviral dapivirine are expected in the next 12 months. Several different HIV vaccine candidates, neutralizing antibodies and long-acting injectable ARVs are currently in trials that could lead to multiple efficacy trials starting over the next two years.

While the report focuses on financial resources, in also highlights the essential role of individual trial participants. In 2014, there were over a million participants in HIV prevention research trials globally. With continued human and financial investment, the 40 percent reduction in new HIV infections attributed to the MDGs is hopefully only the beginning.

For more information on the HIV Vaccines & Microbicides Resource Tracking Working Group, the full report, executive summary, graphics and slides visit www.hivresourcetracking.org.

1 The MDGs consist of eight global goals, with goal six to combat HIV/AIDS, malaria and other diseases. For more information on the MDGs see: www.un.org/millenniumgoals/aids.shtml.

Px Wire July-September 2015, Vol. 8, No. 3

Px Wire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy.

In this issue, we describe the calls to expand ART access to all who need it, which have been amplified over the two months since the results of the START trial. We also document a growing demand for PrEP and the need for updated guidance from the WHO and targets from UNAIDS. And we look at the increasing role civil society is playing at developing PEPFAR Country Operating Plans (COPs) which guide targets, geography, interventions and budget levels on an annual basis.

In our centerspread, we look backwards and forward, at the conferences that took place in Vancouver and Durban in 1996 and 2000 and will again this year and the next.

Download

Demands for PrEP, treatment scale-up, targets and more, all in the new issue of Px Wire

The latest issue of Px Wire, AVAC’s quarterly newsletter on HIV prevention research and implementation, is now available.

Click here to download the new issue.

In this issue we look back at the historic International AIDS Conference that took place in Durban, South Africa, in 2000, how far we’ve come in the response today—and how much further we still need to go.

When the AIDS community gathered in July 2000, the world was still four years away from anything resembling global antiretroviral therapy (ART), but through the activism seen at that conference, the agreement that ART was a human right started then and there. There has since been remarkable scale-up and innovation in the use of ARVs as both treatment and prevention.

This issue of Px Wire describes the calls to expand ART access to all who need it, which have been amplified over the two months since the results of the START trial, which found that initiation of ART in people living with HIV significantly reduced serious clinical events and deaths as compared to people who initiated ART based on the guidelines in their countries.

We also document a growing demand for PrEP, including a robust and spontaneous show of support for expanded daily oral PrEP access for all those at risk by participants at the recent South African AIDS Conference, and the need for updated guidance from the WHO and targets from UNAIDS.

In our centerspread, we again look backwards and forward, at the conferences that took place in Vancouver and Durban in 1996 and 2000 and will again this year and the next.

And we look at the increasing role civil society is playing at developing PEPFAR Country Operating Plans (COPs) which guide targets, geography, interventions and budget levels on an annual basis.

New START Data Fill in When to Start ART, Now the Question is How

New data from a trial looking at the individual health benefits of starting those living with HIV on antiretroviral therapy (ART) at CD4 cell counts above 350 were released today. The data, from a trial known as START, are further evidence in support of the expansion of ART access worldwide. The data from START should also start the clock on even more substantial engagement with the types of ART programs that are most likely to help people make informed choices to begin and remain on life-saving treatment.

It’s now been nearly four years since the release of trial data showing that people living with HIV who started ART at CD4 cell counts between 350 and 500 were significantly less likely to transmit HIV to their sexual partners, compared with people who started according to national guidelines. That trial—known as HPTN 052—may be the single most important factor behind today’s push to use ART to end the epidemic.

In case you’ve been pre-occupied with other parts of the AIDS response like, for example, the war on drug users in Russia or the imperiled VMMC programs in Africa, see UNAIDS’ 90-90-90 campaign for the frontline example of the ART-to-end-AIDS message. AVAC and other allies have been working with UNAIDS, PEPFAR and governments to try to ensure that this message is accurately conveyed and understood as encompassing prevention beyond ART—including saturation-level coverage of VMMC, targeted PrEP, harm reduction and male and female condoms. For more on this work—and why prevention is “on the line” see our most recent Report.

In the wake of early data from HPTN 052, people living with HIV and their allies were quick to point out that the strongest evidence this trial provided was about the prevention benefit of starting ART “early” (i.e., before national guidelines). HPTN 052 did find that earlier initiation had clinical benefits for the individual, including delaying the time to AIDS events, death and tuberculosis. But for many advocates and activists, these data were not definitive and that a real answer would have to come from the START trial, which was a randomized investigation of exactly this question: does immediate initiation of ART improve individual health for people living with HIV?

Today the answer came in, early, and with resounding clarity: Yes.

The START trial, which enrolled 4,685 people at 215 sites in 35 countries (twenty-seven percent of the participants are women, and approximately half are gay men) looked at rates of AIDS, and serious AIDS-defining illness or death in people with CD4 cell counts above 500 who started ART on enrollment in START, versus those participants who also had CD4 cell counts above 500 and delayed treatment until the initiation criteria dictated by the clinical guidelines in their countries.

At a scheduled interim review of the data, the trial’s Data and Safety Monitoring Board (DSMB) found compelling evidence that the benefits of starting antiretroviral treatment immediately at CD4 cell counts above 500 cells/mm3 outweigh the risks. This conclusion was based on the fact that, over an average follow-up period of three years, the risk of AIDS, other serious illnesses or death was reduced by 53 percent among those in the “early” treatment group versus those who started treatment according to national guidelines.

START effectively validates the direction that the WHO’s Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection had begun to take—initiation regardless of CD4 cell count in many populations, including pregnant women, children under the age of five, and people in serodiscordant couples. And it may settle some concerns about whether earlier initiation was good for the person living with HIV—or just for his or her sexual partners and/or potential children.

But it’s critical to recognize that figuring out when to start is only part of the puzzle. The question of how to start is equally critical and isn’t going to be settled by any randomized trial. The how concerns the environment in which individuals are offered treatment, the services that are part of that offer—peer support, community-based refills, non-biased provider care, among others—and the ways that the decision to start is framed. Even with clinical and public health benefits, ART may not be for everyone as soon as they are diagnosed. Issues with disclosure exist everywhere and are compounded in places where laws criminalizing HIV are on the books.

At a time when funding for civil society organizations is dropping everywhere—and when some PEPFAR country programs are placing funding for community engagement as “near- or non-core” (pieces of USG jargon that set priority for PEPFAR funding) —and when UNAIDS has yet to step forward with staunch, straightforward condemnation of rights-violating legislation and hate speech by politicians, this “How?” question is far from resolved.

That’s why START has to be welcomed for what it is—a clear answer to a critical question. And also understood for what it is not—an answer to the urgent challenge of how best to truly seek to end the epidemic with comprehensive prevention programs that include, but are not restricted to, delivering ART so that everyone who wants it can start it, stay on it, achieve virologic suppression and, more importantly, a life lived with health, dignity and joy.

Selected Guide to Pipeline of Antibodies, Long-Acting ARVs and Vaccines

This graphic provides a quick primer on passive immunization with HIV-specific antibodies, long-acting antiretroviral injectables, and preventive vaccines, including a new, informative table reviewing the pipelines in research and development for all three research avenues.

Burning the Candle at Both Ends: An Advocacy Forum Discussion on “Injectable Prevention”

Ntando Yola has worked for eight years in HIV prevention research at the Desmond Tutu HIV Foundation (DTHF) in Cape Town. In his role as a Community Engagement Coordinator he has worked closely with various national and international HIV prevention Networks. His work has involved working with various community stakeholders, developing and implementing community education programmes, forming partnerships with health service providers and other community based organizations as key stakeholders HIV prevention research. He was also a 2013 AVAC Fellow.

At the 2015 AVAC Partners’ Forum, there was a lot of interest in advocates and activists about the important role scientific research has to play in addressing HIV. How important was it? So important that at a roundtable discussion that started after the day was scheduled to end, a small but dedicated group of participants spent over an hour talking about the current pipeline of “injectable prevention” which includes long acting injectable PrEP (I am currently working at DTHF in Cape Town, where an LAI PrEP trial is getting underway), vaccine trials and, someday, passive immunization (right now these antibodies can only be administered via a three-hour transfusion, as we learned at an incredibly accessible presentation by self-described “lab rat’ Penny Moore).

It was clear from this “after hours” discussion that, whilst the focus of community involvement primarily by researchers is within trial communities, there is a need for basic concepts of research and processes to be understood by these broader groups. Addressing this as a gap can go a long way into creating an even more supportive environment for trials and research. Since when civil society understands core concepts and questions related to biomedical research, they are more likely to engage, inform and participate. This would further ensure a natural progression of successful science to real life public health policy and implementation. Whilst globally, initiatives by organizations like AVAC seek to address this, strong and sustained partnerships between science and civil society with countries remain a lingering question as to how this should happen and whose responsibility it is.

I developed a slide set that summarized the pipeline we grappled with and some of the key findings and suggestions that came out of this meeting. There were more questions than answers, as you’ll see. If you want to learn more, raise new questions—or get involved in providing some answers—please be in touch!

Prevention on the Line Webinar Series

AVAC is putting together a year-long series of web-based dialogues focused on HIV prevention research and implementation. This series, HIV Prevention on the Line, will delve into issues raised in our recent AVAC Report and engage with issues and priorities that emerge over the course of the year.

Slides, audio and animations from the first set of webinars are available below. Stay tuned to this page, or subscribe to our Advocates Network newsletter, for details on future webinars.

Vaccines in Vivo: Advances in AIDS Vaccine Research
This year brought the launch of long-awaited initiation of clinical trials building on positive results from the RV144 “Thai” trial. This effort is led by the Pox-Protein Public-Private Partnership (P5), including the the HIV Vaccine Trials Network, who joined the webinar to provide a status update of their current vaccine research and development program. We also featured Janssen, part of Johnson & Johnson, to provide an overview of the research program they are moving forward that focuses on a cross-clade vaccine product.

May 18, 2015 — Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

New Frontiers in HIV Prevention, Treatment and Cure: An advocate’s webinar on passive immunization
This webinar focused on “passive immunization”—a scientific term for an expanding area of research that’s highly relevant to treatment, prevention and cure work. There are trials in humans happening in many regions of the world—and data are beginning to come in that advocates need to understand, analyze and consider.

This hour-long webinar featured Dr. Sarah Schlesinger (Rockefeller University) who provided an overview of recent developments across the field including new data from Rockefeller.

April 21, 2015 — Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

Demanding Clarity on PrEP: Understanding recent data on oral PrEP

This webinar featured Jean-Michel Molina of the French research agency ANRS and Sheena McCormack of the UK Medical Research Council discussing the data from the IPERGAY and PROUD studies, respectively. Both trials evaluated oral TDF/FTC (brand name Truvada) as PrEP in gay men and other men who have sex with men, and both reported high levels of protection against HIV acquisition. PROUD prescribed a daily pill regimen; IPERGAY asked trial participants to follow an “event driven” regimen that involved a sequence of doses before and after sex. IPERGAY participants took an average of four doses per week—comparable to the estimated protective dose required in trials of daily oral PrEP.

March 12, 2015 — Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

Follow the Money: Knowns and unknowns when it comes to cash transfers and financial incentives to improve health in people living with and/or at risk of HIV
This webinar featured Wafaa El-Sadr, principal investigator of HPTN 065, which evaluated the use of cash incentives in improving outcomes for people living with HIV in the United States.

March 11, 2015 — Downloads: Slides (PDF) / Audio (MP3) / Animation (Flash)

After FACTS: What’s next for HIV prevention in women?
Helen Rees, principal investigator of the FACTS 001 microbicide trial of vaginal 1% tenofovir gel, spoke of their findings of no evidence of protection overall associated with the vaginal gel. Jared Baeten, co-chair of Partners PrEP, discussed the Partners Demonstration Project finding that serodiscordant couples using oral PrEP and/or ART had ver low levels of HIV transmission. We discussed what these and other data meant for women, including young and adolescent girls.

March 9, 2015 — Downloads: Slides (PDF) / Audio (MP3)

Does Sex Have Impact on HIV Prevention Research?

This post was written by Morenike Folayan, Coordinator of the New HIV Vaccine and Microbicide Advocacy Society and member of the CROI Community Liaison Subcommittee.

At the CROI meeting, I seem to be getting signals that sex significantly impacts HIV research design, data interpretation and data use.

First, I learned that availability of tenofovir, the drug used for pre-exposure prophylaxis (PrEP), is 10 to 100 times lower in the vagina tissues than the rectal tissues when taken orally. This therefore implies that the results of PrEP studies conducted to assess HIV transmission through anal sex cannot be automatically translated to imply the results would be pan out the same way when considering vaginal sex. Hmmmm.

Second, I also learned, through informal conversation with those who work in the field for ARV studies, that the reasons many HIV positive men decide to commence ARV use for HIV prevention (treatment as prevention, or TasP) differ from the reasons why women do commence TasP. More men commence TasP out of a sense of protection of their sexual partner—they have a higher sense of responsibility to protect their sexual partner from getting infected. Women on the other hand, commence the use of TasP simply because they are eligible to use the product. I found that very interesting. I think there may be cultural differences in this observation. I doubt if this is the case in Africa. However, like the lessons we learn from CROI, we need evidence. I would like to see a formal study evaluate this social context of TasP use by men and women in different cultural setting.

Third, the iPrEx OLE study showed increase uptake of, and adherence to, PrEP by MSM who were at high risk for HIV infection. In the VOICE study, we see less uptake and adherence by women who were at high risk of HIV infection. Hmmm. Are we starting to see differences in cultural perception of risk or is this truly a sex difference in risk perception?

(Editor’s note: In iPrEx OLE, participants knew that they were being offered an effective prevention tool—it was an open label study; in VOICE, women were counseled that they might be receiving a placebo and that none of the strategies were proven. Understanding how context—research site, clinic, public health program or community center—affects uptake and risk perception is also key.)

Reason for more studies on sex differences in PrEP and TasP use. Maybe conducting studies with transgenders may help address this question. Maybe.

CROI Through a Pharmacist’s Perspective

William Larson is an HIV medication adherence pharmacist working in Minneapolis, MN as part of the Ryan White program. He strives to increase HIV treatment literacy in disproportionately impacted communities. He is a graduate of the Black AIDS Institute’s Community Mobilization College in 2013.

Last week I attended CROI 2015 as a community educator scholarship recipient from CROI, in association with the Black AIDS institute and AVAC. It has been a rare opportunity to hear first-hand live presentations of new research by leading HIV researchers.

I got to meet several of the researchers at breakfast updates for scholarship recipients. What an opportunity! I was impressed by the researchers’ approachability and willingness to answer questions.

I was also impressed by the committed and knowledgeable scholarship recipients, all of whom are eager to better understand the new research so that they could bring the information back to their home communities.

As a pharmacist working in HIV medication adherence, I am interested in new therapeutic agents for the treatment of HIV. Information was presented on a new compound, tenofovir alafenamide or TAF as part of single tablet regimen also containing elvitegravir, cobicistat and emtricitabine. This was compared to the currently available single tablet medication, Stribild, which contains elvitegravir, cobicistat, emtricitabine and tenofovir disaproxil fumarate (TDF).

TDF (Viread) is a frequently used medication and part of most HIV treatment regimens. It is found in the combination product Truvada and the single tablet regimens Atripla, Complera and Stribild. Although considered safe for most patients, there are concerns about bone and kidney changes which can occur in some patients with long-term use.

In research presented by Dr. David Wohl, TAF was found “non-inferior” to TDF in achieving viral suppression irrespective of age, sex, race, viral load or CD4 count. In simpler terms, TAF is at least as effective as TDF. Both drugs had low rates of viral resistance and both were well tolerated.

Dr. Paul Sax presented data on renal and bone safety of TAF compared to TDF. This research demonstrated that TAF has less effect on the kidney (serum creatinine and urinary protein) and bone (bone mineral density) compared to TDF, with slightly higher lipid levels from TAF.

In the clinic where I work, we are discontinuing or replacing TDF weekly in select patients with elevated creatinine levels. Although we are discontinuing TDF less often for bone changes, it is possible that is a problem which might be detected or develop later in patients on life-long therapy.

Why does TAF appear to be safer than TDF, with fewer kidney and bone changes? Compared to TDF 300 mg, TAF 25 mg produces 90 percent lower level of tenofovir in the plasma. Tenofovir is responsible for the bone and kidney changes. TAF, like tenofovir, is converted to tenofovir diphosphate intracellularly and this is the compound with antiviral properties.

Tenofovir alafenaide or TAF is a safer and equally effective alternative to TDF, and will likely become the preferred alternative for individuals now receiving a TDF-containing product.

My sincere thanks to CROI, AVAC and the Black AIDS Institute for allowing me and others to attend CROI and their commitment to disseminating the latest research to our most heavily-impacted communities in the United States and around the globe.