Give Us the 2-in-1 HIV Prophylaxis

In this Mail and Guardian editorial, South African advocates call on the South African government and health department to do its part to expand the provision of PrEP and integrate it into combination treatment and prevention programs before “people are agitated and take to the streets to demand these tools”.

South Africa has rolled out the largest antiretroviral treatment program in the world—about 3.1 million people are now on treatment, according to health department figures.

This is a remarkable, given the earlier years of poor political response. But South Africa still has unacceptably high rates of infections and HIV remains a public health emergency.

Within the general epidemic in South Africa, some specific population groups—such as sex workers, gay men and other men who have sex with men (MSM), discordant couples (where one partner is HIV-positive and one HIV-negative), truckers and people who inject drugs—have higher rates of HIV and require specialised interventions.

The disease takes a particularly devastating toll on the lives of adolescent girls and young women between the ages of 15 and 24, a rate more than four times that of their male counterparts, according to the Human Sciences Research Council’s 2012 National HIV Prevalence, Incidence and Behaviour Survey.

The HSRC survey, also found that more than 400,000 new HIV infections occurred in 2012, bringing the number of people infected in South Africa to 6.8 million in 2014.

A disturbing picture
These statistics present a disturbing picture of the HIV epidemic and our response. In delaying the implementation of pre-exposure prophylaxis (PrEP), has South Africa failed to embrace the wisdom of science?

This new option for HIV-negative people at substantial risk of HIV infection is a combination antiretroviral drug, TDF/FTC, taken once a day, which can drastically reduce their chances of becoming infected. Research studies show that, when this two-in-one pill is taken correctly and consistently, it is more than 90 percent effective.

There have been unexplained delays by the Medicine Control Council to approve and license TDF/FTC as pre-exposure prophylaxis and the department of health’s response to South Africans voicing their demand for this action has been silence. The council should approve TDF/FTC before the end of this year.

New guidelines
Advocates welcomed the World Health Organisation’s (WHO) new guidelines for HIV treatment, released in September. These recommend that: “Oral PrEP… should be offered as an additional prevention choice for people at substantial risk of HIV infection as part of combination HIV prevention approaches”.

The new guidelines have broken the silence among policymakers on the future of pre-exposure prophylaxis in South Africa. Following their release, Yogan Pillay, the health department’s deputy director-general for HIV, endorsed the WHO guidelines in an article in the Mail & Guardian. This demonstration of commitment is an important step in realising our dreams about providing pre-exposure prophylaxis.

As HIV prevention advocates, we talk to many people, including potential users of TDF/FTC. We hear from a host of people from all walks of life who are demanding pre-exposure prophylaxis. They want to know when the drug will be available in South Africa and how they can get access to it. These questions have been previously been impossible to answer, but now we hope to work with health department. Will the department follow through on its commitment and the ethical imperative to provide medicine that is a crucial step in confronting the HIV epidemic?

We would like to see such a programme rolled out in the shortest possible time, and through existing structures, where possible.

We know that implementation of this new intervention will not be easy. It requires political will, dedicated advocacy, domestic sources of funding and international donor commitment.

More importantly, investment must be based on decisions that are driven by evidence rather than sentiment. The health department will need support from a variety of stakeholders—much of which can and will come from the huge groundswell of civil society support for the implementation of a pre-exposure prophylaxis programme.

Timeline
As we prepare to support the department in planning and executing such a roll-out, we have questions. What are the department’s plans for this? What are the timelines? Has the department started seriously with advocates in the provinces? What are the advocacy issues that civil society can push?

We need effective models to deliver PrEP. Demonstration or pilot projects in South Africa and around the world will provide us with the knowledge to guide a roll-out in real-world settings. The health department can also take advantage of data on existing public health programmes that can be adapted for providing TDF/FTC.

Some organisations that already provide comprehensive HIV prevention services are suggesting that the department use existing structures and services to start and expand the provision of PrEP and integrate it into combination treatment and prevention programs.

Within these organisations, there are champions who have already established positive working relationships in communities. They can help to identify barriers to implementing and recommend strategies to address the barriers.

Recommendations
Young women tell us, “We recommend that youth-friendly clinics be established and that health staff be sensitised about the unique needs and problems that young people face.” Similarly, sex workers have suggested that TDF/FTC should be provided “within user-sensitised facilities” and, where possible, through mobile clinics. Men who have sex with men are calling for the medicine and some are already getting it from private clinicians through “off label” prescriptions.

As advocates, we will continue our work to educate the public about TDF/FTC, how to get it and how it can further strengthen existing HIV prevention efforts. But we know that there is more to be done through working closely with people and with social marketers.

We will also continue preparing for the results of a vaginal microbicide ring study expected early next year. The vaginal ring, another form of PrEP, slowly releases the antiretroviral drug dapivirine over the course of a month. If proven safe and effective, the vaginal ring could expand options for women-initiated HIV prevention methods.

Civil society is working with the International Partnership for Microbicides, the organisation which developed this technology, and other partners who conducted microbicide research among South Africans to plan for the results and introduce the product if it is proven effective. No microbicide has yet been licensed for use.

We acknowledge South Africa’s remarkable success in fighting HIV. There is now opportunity to build on these successes by taking advantage of new innovations such as TDF/FTC to reduce the chance of infections and save on treatment costs. HIV-negative South Africans have a right to use this life-saving intervention now.

We should not have to wait until people are agitated and take to the streets to demand these tools.

Will South Africa show global leadership and take immediate action to get PrEP into people’s hands? Or will our collective conscience be haunted in years to come, knowing we could have averted new infections and saved on costs of lifetime HIV treatment and sickness? The science is clear that TDF/FTC works when taken correctly and consistently; now we must follow this evidence and act on it.

John Mutsambi is an AVAC Fellow. AVAC is a US based organisation that advocates for HIV prevention to end AIDS. Brian Kanyemba, Yvette Raphael and Ntando Yola are the leaders in PrEP advocacy in South Africa.

Six Things to Know About PrEP

Six things to know about PrEP. For more information on PrEP, visit PrEPWatch.

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.

Anatomy of a Target – DREAMS

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 the DREAMS program.

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

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

We’re especially excited about our centerspread graphic (see below) which looks at the sum total of the new targets and guidelines and gives our “take” on whether the current context is on target.

Click here to download.

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].

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: [email protected].

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: