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.

This issue is also available as a webpage.

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.

Pre-Exposure Prophylaxis for Prevention of HIV Infection

This column first appeared in the Zambia Post.

Three years ago, the HIV and AIDS world received news that the authoritative US Federal Drug Authority (FDA) had approved the use of the antiretroviral combination pill Truvada by HIV negative people to reduce the risk of acquiring HIV infection (Truvada combines the two ARVs Tenofovir and Emtricitabine and is often shortened to TDF/FTC).

Within days of this announcement, the WHO issued its GUIDANCE ON PRE-EXPOSURE ORAL PROPHYLAXIS (PrEP) FOR SERODISCORDANT COUPLES, MEN and TRANSGENDER WOMEN WHO HAVE SEX WITH MEN AT HIGH RISK OF HIV: Recommendations for use in the context of demonstration projects.

The FDA approval, and the WHO guidance, followed results from clinical trials that showed that the daily taking of ARVs (specifically Truvada) by HIV negative people (men and women) exposed to HIV infection, significantly protected them from the acquisition of the virus.

One such study, the PARTNERS PrEP Trial, was done in Uganda and Kenya and involved 4,758 HIV-discordant couples (in which one partner was HIV infected and the other negative). The trial showed that if the HIV negative partner took daily Truvada, they were 75 percent less likely to become infected (than those who took a daily pill that did not contain Truvada or any other ARV). Adherence to taking the Truvada daily was important in improving the protection it offered. Amongst those HIV negative partners who showed that they were complying with taking the drug daily (as demonstrated by the presence of detectable medicines in their blood, PrEP reduced their risk of HIV infection by 90 percent).

Another study, known as the iPrEx Study, was also done among men and transgender women who have sex with men. It was done in Peru, Brazil, Thailand, South Africa and the United States. In that study, those HIV negative people who were given PrEP were 44 percent less likely to get HIV infection, than those who were not. In those men who took their pills consistently (as evidenced by blood tests) PrEP reduced their risk of HIV infection by as much as 92 percent.

The clinical trials demonstrated that taking the PrEP consistently daily is key to achieving high levels of protection from infection.

In its guidance on PrEP, the WHO was characteristically cautious in its advice to governments, stating: “Although the evidence of effectiveness is strong, it remains unclear how PrEP may be implemented and scaled up in settings where its use might be most beneficial.”

The guidance also stated that WHO was encouraging countries to undertake demonstration projects, and would “offer advice on key questions and areas that could be addressed to facilitate understanding of the safety, effectiveness and sustainability of oral PrEP, and its use as an addition to existing HIV prevention efforts”.

“The outcome of these demonstration projects and country experience will also be used by WHO in 3 to 5 years time to develop guidance for the implementation and scale up of PrEP,” the 2012 WHO guidelines promised.

The guidelines’ specific recommendation on PrEP for serodiscordant couples says: “In countries where HIV transmission occurs among serodiscordant couple, where discordant couples can be identified and where additional HIV prevention choices are needed, daily oral PrEP (specifically tenofovir or the combination tenofovir and Emtricitabine) maybe considered as an additional intervention for the uninfected partner”.

In May last year, the United States’ Public Health Service released its comprehensive clinical practice guidelines for PrEP called ‘Pre-exposure Prophylaxis for the prevention of HIV infection in the United States-2014″.

These guidelines stated at the end of a review of the PrEP trials in men and women; “Daily oral PrEP with TDF/FTC is recommended as one HIV prevention option for heterosexually active men and women at substantial risk of acquisition because these trials present evidence of its safety and to present evidence of efficacy in these populations, especially when medication adherence is high”.

Similar recommendations are made for sexually active MSM and injecting drug users.

Notably, both the WHO guidance and the CDC-led US Public Health Service clinical practice guidelines emphasize that PrEP cannot and should not be taken in isolation, or as replacement of existing prevention efforts and methods. Both stress that PrEP should be used as “one prevention option” that should be “an addition to existing HIV prevention efforts”. This is highly significant because even while on PrEP, HIV negative people should continue using condoms; reduce on multiple concurrent sexual partnerships etc.

So what are the implications of PrEP, prevention of new HIV infections in Zambia, and the general Zambian HIV and AIDS response?

Issues of the paucity or lack of domestic funding of our response aside, there is a deafening lack of noise on PrEP in our national HIV and AIDS conversation. Since the FDA approval and the subsequent issuance of WHO guidelines, we have heard more spoken around Option B+, Test and Treat, VMMC, sex work and sex workers, defining key populations, getting Zambia to zero new infections and so on. Even this column has referred to PrEP mostly in passing and in context of other HIV prevention subjects.

One wonders if perhaps the silence on PrEP has been fueled by the international publicity and discussion around the iPrEx study and its results implications for preventing HIV infections among men who have sex with men. Has Zambian officialdom’s fear of recognizing the existence of Zambian MSM and transgender people clouded or completely blacked out a potentially beneficial addition to our armamentarium of evidence-based and proven HIV prevention interventions?

Some of the seminal work on serodiscordance in married and cohabitating couples has been done here in Zambia. In our fear of addressing MSM issues and related HIV, are we denying serodiscordant couples in Zambia an intervention that is available now to similar couples in the US, using a drug combination that is available and approved for treatment in Zambia?

The least we can do and bring up to the public arena the fact that PrEP works is that we should be debating the pros and cons of its implementation as a nation!”

Demanding PrEP at SA AIDS 2015: Scenes from an Activist “Smackdown”

Fifteen years after activists marched for HIV/AIDS treatment access at the International AIDS Conference in Durban in 2000, a group of South African activists are demanding access to PrEP for HIV prevention as an option for all South Africans who need and want it.

In a statement issued today, activists called for swift action to get daily oral Truvada as PrEP approved for South Africa and to expand access to PrEP for all who need it. They also warned against anti-PrEP propaganda noting that, “As South Africans, we know too well the human cost of misinformation about HIV and of waiting too long to implement life-saving, evidence-based HIV interventions. We call on the MCC of South Africa and the Department of Health to prioritize enabling access to this HIV prevention medication.” (Full statement available here.)

Shortly after the statement was finalized, International AIDS Society president Chris Beyrer delivered a plenary address at the South African AIDS Conference (SA AIDS), during which he—as one advocate in the audience described—offered a “a full-throated endorsement of PrEP, made a specific call for PrEP in Africa, South Africa, and called to task PrEP denialism”. He even presented a summary slide of the local activists’ statement:

The activism continued into the evening as activists crowded the room during a satellite session and voiced their support for PrEP in South Africa (and beyond) and brought clarity and facts to a discussion on PrEP data, feasibility in the South African context and the true need and wants of communities on the ground.

Long-time AIDS treatment and prevention activist Peter Staley described the activists’ comments in a POZ blog and pictures and quotes from the action from Twitter are summarized here.

Check back on the P-Values blog for more from the conference and voices from local activists and partners moving the HIV prevention research and implementation agendas.

South African AIDS Activists Demand PrEP Now

Durban, KwaZulu-Natal, South Africa — South African advocates call for Truvada as Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection to be made available to all those who need it now. Truvada as PrEP is an effective and safe medication that has been proven to reduce the risk of HIV infection for all populations. Clinical trials from a multitude of respected institutions and physicians have shown that PrEP works when taken as directed.

As the 7th SA AIDS conference gets underway in Durban, a diverse collection of advocates have assembled to call on the South African Medicines Control Council (MCC) to immediately approve the use of Truvada PrEP. PrEP must be made available and accessible to South Africans who are at heightened risk of infection, and would benefit from an additional tool to prevent HIV. South Africa is the most impacted country by HIV in scope and scale. To turn around our epidemic, South African young women and girls, gay men, sex workers, and people who use drugs need PrEP as an additional HIV prevention option.

We, South African advocates, are alarmed to see the AIDS Healthcare Foundation (AHF), an American-based chain clinic and pharmacy that has led the charge in PrEP Denialism, participate at the Durban Aids Conference. The AHF has consistently opposed PrEP using faulty science and fear mongering and has failed to accept extensive research that has clearly and repeatedly shown PrEP to be safe and efficacious. South Africa can only allow evidence-based health policy and implementation. Denialism thrown in the face of facts and research can never be allowed again. As South Africans, we know too well the human cost of misinformation about HIV and of waiting too long to implement life-saving, evidence-based HIV interventions.

We call on the MCC of South Africa and the Department of Health to prioritize enabling access to this HIV prevention medication. Over 1,200 infections occur in South Africa each and every month. It is imperative that we use every option available to reduce new HIV infections, thereby reducing the number of people who will spend their lives on ARVs.

For more information please contact:

PrEP Funding Opportunity Announcement

Through the Corporate Grants program, Gilead is looking to support efforts of community-based organizations, public health entities and similar umbrella organizations focused on high-risk populations to educate their constituents and healthcare providers about the role of PrEP as part of comprehensive HIV prevention. Gilead will consider a wide range of ideas that reach diverse geographic locations within the United States.

 

Find out more by visiting:  http://hivdatf.org/2015/06/02/pre-exposure-prophylaxis-prep-for-hiv-prevention-funding-opportunity-announcement/

After FACTS: What’s next for HIV prevention in women?

FACTS 001, which released data at CROI, found no evidence of protection overall associated with the vaginal gel. Partners Demonstration Project, which reported data at the same meeting, found that serodiscordant couples using oral PrEP and/or ART had very low levels of HIV transmission. In this webinar, we discussed what these and other data meant for women, including young and adolescent girls.

Government Should Give Guidance on Drugs that Prevent HIV

This piece by a 2014 AVAC Fellow marks the latest efforts by Ugandan civil society to secure pre-exposure prophylaxis (PrEP) access. Author Charles Brown is an advocate, based at the Infectious Diseases Institute (IDI), who spent the last year and a half advocating for PrEP rollout for groups at high-risk of HIV infection including young women, sex workers, men who have sex with men and serodiscordant couples in Uganda. Read his article here.

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.

Px Wire April-June 2015, Vol. 8, No. 2

Px Wire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. In this issue, you’ll find updates and how WHO is approaching broader guidance on oral PrEP and a closer look at passive immunization.

Our centerspread 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.