Px Wire October-December 2015, Vol. 8, No. 4

In this issue of Px Wire, our quarterly newsletter, we decipher the strengths and limitations of the multiple recent developments impacting HIV prevention: new PEPFAR targets, new UNAIDS targets, new guidelines on ART and PrEP from the WHO and new Sustainable Development Goals. What does each development mean, and how do advocates tailor their advocacy accordingly?

The New Context for HIV Prevention: Is the world on target?

In this issue of Px Wire, our centerspread graphic looks at the sum total of the new targets and guidelines and gives our “take” on whether the current context is on target.

Truvada as PrEP: A new HIV prevention option on the table for Zimbabwe?

Zimbabwean advocate Paul Sixpence’s opinion piece, Truvada as PrEP: A new HIV prevention option on the table for Zimbabwe? was published in The Zimbabwe Chronicle. Given scientific evidence that PrEP works, he calls for PrEP rollout for young women, sex workers and serodiscordant couples in Zimbabwe. Paul’s work centers on the use of media as an advocacy tool to push for policy support around new HIV prevention science.

Recent policy pronouncements by the World Health Organisation (WHO) recommending national public health systems to incorporate Truvada as Pre-Exposure Prophylaxis (PrEP) into their prevention interventions present a new revolution in the fight against new HIV infections. The WHO guidelines came on the background of overwhelming science that proves that Truvada as PrEP works when taken correctly as presented at two major global HIV and AIDS conferences namely the 2015 Conference on Retroviruses and Opportunistic Infections (CROI) and the International AIDS Society (IAS) 2015.

In light of scientific evidence that proves that PrEP works and considering the burden of HIV and AIDS to Zimbabwe’s socio-economic development, this instalment advocates for PrEP roll-out for young women, sex workers and sero-discordant couples in Zimbabwe.

What is PrEP?

Pre-exposure prophylaxis is the use of antiretroviral medications (ARVs) to reduce the risk of HIV infection in people who are HIV negative. Truvada is an ARV that has been approved in Zimbabwe for treatment purposes. In a nutshell, PrEP is the taking of preventive drugs to prevent primary infection prior to engaging in a potential risky sexual encounter that can possible expose one to HIV infection. In other words, it is akin to taking anti-malaria tablets prior to getting into a malaria zone.

Evidence that proves that PrEP works

This article is based on the TDF2 and Partners PrEP clinical trials. TDF2 was conducted in Botswana among young heterosexual couples and Partners PrEP was conducted among sero-discordant couples in Kenya and Uganda. Both clinical trials exhibited efficacy rates of over 80 percent.

PrEP efficacy and feasibility case studies presented in this piece have been deliberately chosen because they were conducted in Africa and in resource constrained settings relatively similar to those obtaining in Zimbabwe. There are other clinical trials that have been conducted in France, Britain, Brazil and the United States of America, among diverse sets of population and they all indicate that PrEP works.

Taking note of all these positive and inspiring findings in the field of HIV biomedical interventions, the president of the International AIDS Society and Chair of IAS 2015, Chris Beyrer had this to say:

“The science on PrEP is overwhelming and its conclusions are clear: PrEP works when taken. Access to PrEP is now a public health and human rights imperative. The studies presented here [at IAS 2015] provide the most detailed data to date on PrEP implementation successes and challenges, underscoring that the intervention is feasible and effective in the real world. We hope these studies launch the beginning of a new PrEP era.”

Current global trends in adopting PrEP

PrEP was licensed for treatment purposes in the United States of America in July 2012. Applications for regulatory approval have been filed in Australia, Brazil, Canada, South Africa and Thailand.

Is PrEP for Zimbabwe?

PrEP is not for everyone but for specific populations at high risk of infection. Among those who are in need of PrEP in Zimbabwe are key populations, namely, young women, sero-discordant couples and sex workers.

Presenting oral evidence to the Parliament of Zimbabwe Thematic Committee on HIV and AIDS in July 2015, National AIDS Council (Nac) Chief Operations Officer, told the Committee that his organisation was worried about the increasing rates of new infections among girls and young women between the ages of 15 and 24 years.

He noted that about 80,000 young girls and women were living with HIV as compared to 36,000 of their male counterparts. These statistics speak of an urgent need to offer young women with a wide range of HIV prevention options.

According to the Centre for Sexual Health and HIV/ AIDS Research (Ceshhar) out of 52,214 sex workers almost 11,000 (20 percent) are living with HIV. These figures speak of an urgent need to provide sex workers with new and effective solutions in preventing primary HIV infection in addition to messages on correct and consistent use of condoms and behaviour change.

The way forward

There is an urgent need for collaborative engagement between policy makers in relevant State institutions, HIV and AIDS researchers and civil society actors to analyse the science that proves that PrEP works with the local context in mind, work on regulatory approval, develop guidelines and roll-out PrEP to those at high risk of HIV infection and who need it.

From November 29 to December 4, 2015, Zimbabwe will host the International Conference on AIDS and STIs in Africa (ICASA).

In light of the encouraging PrEP efficacy and feasibility results, ICASA 2015, should serve as a marketplace of ideas and exchange of knowledge on how to mobilise resources for PrEP roll-out, enhancing the capacity of public health systems to integrate PrEP into their existing comprehensive HIV treatment and prevention packages and ways of raising awareness among people of the existence of this new HIV prevention option.

Paul Sixpence is an HIV prevention and treatment advocate and 2015 AVAC fellow. He can be contacted at: psixpence@gmail.com.

Pre-exposure Prophylaxis in Kenya, Can it be Real?

Kenyan advocate Carolyn Njoroge published an opinion piece, Pre-exposure Prophylaxis in Kenya, Can it be Real?, calling for immediate action on PrEP as an HIV prevention option for individuals at high risk of HIV infection. An openly HIV positive activist and sex worker herself, Carolyn lauds the Kenyan government for including PrEP in its roadmap to an HIV-free Kenya by 2030 but challenges them, and other governments, to talk less and act more.

This is a timely piece given that just last week, on September 30, WHO issued an “Early Release Guideline” on when to start antiretroviral therapy and on pre-exposure prophylaxis (PrEP) for HIV. Carolyn is a 2015 AVAC Fellow advocating for the roll out of PrEP that would empower and protect sex workers, and other key populations. She is hosted by the Kenya Sex Worker Alliance (KESWA). Read more about her advocacy activities here.

Groundbreaking New WHO Guidelines on ART and PrEP

UPDATE: Slides and audio from the webinar mentioned below are now available. Click here.

WHO today issued an “Early Release Guideline” on when to start antiretroviral therapy and on pre-exposure prophylaxis (PrEP) for HIV. This document recommends 1) initiation of ART in adults living with HIV, regardless of CD4 cell count, and 2) offer of PrEP as a prevention option to all people at substantial risk of acquiring HIV. (The release is “early” relative to a comprehensive update of its consolidated ARV guidelines, slated to come out at the end of the year.)

If implemented, these sweeping recommendations have the potential to change the world by simplifying ART for people living with HIV and revolutionizing prevention for people at risk. So it is, first, a moment for some celebration. At AVAC, we can’t think of another time in the history of the epidemic when there has been a simultaneous game-changing shift on two fronts—prevention and treatment. Of course, the boundaries are blurred—effective ART in people living with HIV also reduces the chances that they will pass on the virus, so it is a prevention innovation, too. Now the real work begins: figuring out how to bring the blurred boundaries into sharp clarity in comprehensive national plans and global strategies.

As we celebrate, we also note the great work that lies ahead to ensure that these guidelines are turned into practice. There are funding and logistics hurdles, and there are also major information gaps. PrEP-awareness is growing, but there are still plenty of questions—see below for links to some key resources. And ART “on demand” is a wholly new concept in many parts of the world where people were told to wait until they were sick or approaching low CD4 cell counts to begin.

The work of answering these questions with smart implementation, rapid data collection and analysis, and expanded funding for civil society-led service delivery and advocacy is great work indeed. And we can’t wait to get started!

To get the conversation going, here are a few key points from an initial read of the document, as well as some additional background resources related to daily oral PrEP and the new guideline.

In addition, join advocates on a global webinar with representatives from WHO to hear more and ask questions on Monday, October 5:

Guidelines overall:

  • The document lays out four principles that should underpin implementation efforts. One that civil society will need to ensure is enacted is: “Implementation of the guideline needs to be accompanied by efforts to promote and protect the human rights of people in need of HIV services, including by ensuring informed consent, preventing stigma and discrimination in the provision of services and promoting gender equity.” (Click here for more on the barriers and facilitators to women’s access to ART.)

Immediate initiation of ART:

  • The guideline calculates that, if implemented, immediate initiation of ART would increase the number of people living with HIV eligible for treatment by up to 35 percent.
  • Throughout the discussion of on-demand ART—which is broken down by age groups, but not disaggregated by gender or other identity—there is recognition of knowledge gaps in how to deliver ART on demand. The guideline refers to qualitative research with people living with HIV and a literature review highlighting messages about how early ART can reduce mortality risk, compared to waiting until CD4 thresholds from former guidance.
  • The guideline contains a bit of a mixed message regarding CD4 cell count versus viral load. Noting that “it may be reasonable to reduce or stop CD4,” the document also says that CD4 has an important role to play in many contexts.

PrEP:

  • The recommendation of PrEP for all people at substantial risk expands prior WHO guidance focusing on men who have sex with men and serodiscordant couples. Importantly, it vastly expands the likelihood that oral PrEP will be offered to adolescents and young women. As it is the first intervention that women can use discretely—not at the time of sex—this is a potentially profound development, and one that can lay the groundwork for other tools in the pipeline, such as the vaginal dapivirine ring, which is in trials, with data expected in early 2016.
  • But what does substantial risk mean? Well, WHO will tell you—it means living in a context or community where the background incidence (number of new cases of HIV per year) is 3 percent. This doesn’t mean the overall incidence in your country has to be 3 percent—but that this is the estimated or documented rate in a context like serodiscordant couple-hood, being a man who has sex with men, a person in prison, a sex worker, an adolescent girl. The reason it’s phrased this way, WHO says, is to allow offer of PrEP “based on individual assessment, versus risk group.” WHO also notes that there are times when PrEP should be offered at a lower incidence, too.

Some more resources:

Press Release

New WHO guidelines on ART and PrEP can put the world on track to end AIDS – If they are implemented quickly and comprehensively says AVAC

Contacts

Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375

New York, NY — Today’s World Health Organization (WHO) “Early Release Guideline” on antiretroviral therapy (ART) for HIV treatment and pre-exposure prophylaxis (PrEP) for HIV prevention has the potential to change the world and help begin to end the AIDS epidemic – if the guidance is swiftly and comprehensively funded and implemented. The new guideline recommends providing ART to all adults living with HIV, regardless of CD4 cell count, and offering oral PrEP as an additional prevention option to all people at substantial risk of acquiring HIV.

“This is a cause for celebration,” said Mitchell Warren, AVAC Executive Director. “WHO is paving the way for a fundamental shift in the world’s response to HIV – abandoning the partial or piecemeal use of antiretroviral medicines in favor of full access for men and women in need. Both science and conscience demand that we put these recommendations into effect as quickly as possible.

“If fully funded and implemented, the recommendations will greatly simplify ART for people living with HIV and revolutionize prevention for people at risk. But there is much work ahead to translate them into practice, from securing resources to revamping HIV guidelines in country after country to implementing comprehensive treatment and prevention programs. These new recommendations will contribute to achieving the #GlobalGoals agreed by the UN last week; now global leaders like PEPFAR and the Global Fund and national governments must begin rallying resources and laying out a vision for action.”

ART “on demand” is a wholly new concept in many parts of the world, where people have long been told to wait until they were sick or approaching low CD4 cell counts to begin treatment. Much work will need to be done to ensure that this guidance is understood and implemented.

The recommendation of PrEP for all people at substantial risk replaces prior WHO guidance focusing on men who have sex with men and on heterosexual couples in which one partner is HIV positive and the other negative. Importantly, it vastly expands the likelihood that oral PrEP will be offered to young women, offering them a long-needed prevention option that they can use discretely, not at the time of sex—a profoundly important development.

AVAC works in coalition with advocates, activists and scientists on advancing an effective AIDS response, and many partners welcome the news and call for immediate action.

“We are hoping that the WHO guidelines push governments in the right direction and finally policy makers will move to making both treatment and PrEP available to those who desperately need it,” said Yvette Raphael, a human rights activist who recently completed a year-long project focused on addressing the HIV prevention, treatment, and sexual and reproductive health needs of young South African women. “In South Africa, many young women have expressed the need for PrEP to be available as an option that will work for them. PrEP can help young women and girls take more control of their sexual and reproductive health rights and be more empowered to control their own sex lives. As a woman who has been living with HIV for 15 years, I know the importance of taking control of all aspects of your life and health.”

“Women living with HIV have been on the frontlines of demanding access,” said Lillian Mworeko, Director of ICW EA. “Now we are on the frontlines of demanding programs that include and prioritize peer support, civil society partners, and a rights-based, treatment-literacy oriented approach to the offer of ART to all.”

“A revolution in HIV prevention is now underway,” said Tom Craig, who participated in the IPERGAY trial, and advocates for improved HIV treatment and prevention. “The concept of combination prevention is now widely accepted, and now PrEP is a part of that revolution. The problem is that few people know about it, especially those in key populations, where the rate of new infections are at an all time high. When will we have access to it? Why is it taking so long? How many more people need to be infected before our governments take action?”

“As a sex worker and prevention advocate from Kenya, I have traveled my country speaking about PrEP,” said Carol Njoroge, a rights activist with the Kenya Sex Worker Alliance and a 2015 AVAC Fellow focused on expanding PrEP access. “I see that most of the people at high risk of HIV who know about PrEP and how effective it is, want it. There is demand from male, female and transgender sex workers and others at high risk for HIV, and we have PrEP demonstration studies looking at how best to provide PrEP in the real world. And in Kenya we have a “Prevention Revolution Roadmap.” But there’s still a lot more needed: clear clinical guidelines, regulatory approval, civil society partnership and funding commitments to make PrEP a reality in Kenya. These recommendations from WHO at this time – can help Kenya move towards PrEP rollout.”

AVAC is committed to working with these and other partners around the world to ensure that the new treatment and PrEP recommendations are put into practice as part of comprehensive programs that address and protect human rights, minimize gender inequities and include tailored packages of proven strategies including harm reduction, male and female condoms and voluntary medical male circumcision—a critical intervention to bring to scale in any epidemic driven by heterosexual transmission.

“We can’t let these groundbreaking guidelines sit on a shelf,” said Warren. “If taken seriously, they can help ensure that millions of people with HIV live long and healthy lives, and that millions more women and men at high risk can remain uninfected.”

At the same time, continued research into additional prevention options is critical. Two efficacy trials of a monthly vaginal ring with a different ARV called dapivirine; phase II trials of two different injectable ARVs, used every two or three months; a phase II daily rectal microbicide gel; ongoing HIV vaccine trials and new passive antibody studies may eventually provide additional options for young people and others at high risk of HIV.

“These guidelines are also an important reminder of the essential work of crafting, funding and implementing a truly comprehensive, integrated and sustained response that links rights-based prevention, treatment and research to end the epidemic,” said Warren.

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

USCA: What Kind of Advocate Are You?

Minister Rob Newells is a member of the staff at Imani Community Church and serves as Board Chair for AIDS Project of the East Bay in Oakland, California. He is also a member of AVAC’s PxROAR program.

During the Black PrEP Summit pre-conference and throughout #USCA2015, advocates and researchers discussed and debated how to get more African Americans on PrEP. When exactly did we shift from advocating for our communities to advocating for the pharmaceutical industry? As advocates, what is our goal? Are we biomedical prevention and treatment advocates with the goal of getting as many people as possible on effective prevention and treatment drugs? Are we community advocates with the goal of being the voice for those people who are living with or at-risk for HIV infection to make sure communities get what they want and need? Can we be both at the same time?

At the International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver a couple of months ago, researchers presented findings of the ATN 110 study of gay and bisexual men ages 18 to 22. At the outset of the study—up until about week 12—black participants had adherence that was close to, though just under, the threshold of four doses per week believed to be needed for protection in men who have sex with men. But adherence dropped off dramatically after week 12, which was also the time where clinic visits went from monthly to quarterly. By week 48 median drug levels were barely above zero indicating very little use of PrEP. Why?

Advocates and researchers are asking otherwise healthy young black men with an understandable mistrust of science and medicine shaped by historical and contemporary issues of prejudice and miscommunication to commit to seeing a doctor and getting blood drawn four times a year and taking a pill every day. When they don’t, we call them ignorant or uneducated. We target them and shame them for not jumping on the PrEP bandwagon. What kind of advocate does that?

It has been said that with effective treatment and PrEP we have all the tools we need to end the HIV epidemic in the United States, but during NMAC’s Master Series on Race at USCA Dr. Victoria Cargill expressed an opinion that “we will never treat our way out of HIV.”

Yes. Treatment works, but treatment can’t work by itself. Everyone knows that structural inequities must be addressed in order to end the HIV epidemic. Everyone knows that stigma must be addressed in order to end the HIV epidemic. Everyone knows that HIV criminalization must be addressed in order to end the HIV epidemic. Everyone knows that what Dr. Cargill said is true. So, what kind of advocate are you?

I am a PrEP educator in my community. I am an advocate for increasing access to PrEP in my community. I am not a PrEP advocate. I am a community advocate through and through. Before I was an advocate (or a Board Chair), I was a same gender loving black man from Deep East Oakland living with HIV. I made a commitment to my community to give them the truth and represent them honestly with no strings attached. In the words of the Dr. Seuss’ Horton, “I meant what I said, and I said what I meant. An [advocate’s] faithful one-hundred percent.”

EATG 2015 Webinar 1: An update on PrEP in Europe

This series of three webinars, hosted jointly by EATG and AVAC, was designed to prepare and update EATG members for a special meeting on new developments in prevention January 2016 in Brussels. The first webinar addressed the latest updates on PrEP in Europe. Speakers: Dr Valentina Cambiano of University College London, Daniela Rojas Castro of AIDES and Dr Anastasia Pharris of the European Centre for Disease Prevention and Control (ECDC).

Transgender Women and PrEP: What’s the latest?

The US Women and PrEP Working Group and partners had a first-hand look at PrEP and transgender women — through the eyes of women prescribing it, using it, choosing not to use it, advocates calling for more research on it and policy-makers charged with integrating it into the national HIV response.

You can click here to view the video.

Slides are also available here.

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.