The major change being effected is that men who have sex with men will be deferred from donating blood for twelve months since last sexual contact with another man, instead of being indefinitely deferred. This guidance can be found at www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf.
FDA announces final guidance re HIV transmission by blood and blood products
South Africa and Kenya Approval of Oral PrEP Should Spur Rollout
Less than a month after South Africa’s national regulatory authority, the Medicines Control Council, approved tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, or trade name Truvada) for PrEP, Kenya took the same step. The country’s Pharmacy and Poisons Board (PPB)—the regulatory body that considers new drugs—also approved TDF/FTC for PrEP for adults at high risk of sexually acquiring HIV-1 infection.
Notably, the PPB made this decision within 30 days of receiving a submission from Gilead, the drug’s manufacturer. This swift approval sets a strong precedent for other countries and should spur other countries and global health organizations to quickly follow suit.
Both countries’ approvals of TDF/FTC as PrEP is the capstone on a transformational year for PrEP. The French Ministry of Health granted provisional approval of TDF/FTC as PrEP in November; the World Health Organization recommended PrEP as an additional prevention option for all people at substantial risk of HIV infection worldwide in September; and the PEPFAR Scientific Advisory Board recommended swift integration of PrEP into comprehensive HIV prevention programs in PEPFAR countries. This October recommendation came with a particular focus on young women at high risk as well as gay men and other men who have sex with men, and recommended steps to overcome regulatory barriers in countries where PrEP is not yet approved.
Daily oral PrEP is finally beginning to take its place as a core element of global HIV prevention.
But PrEP rollout is still happening far too slowly for millions of women and men at risk for HIV. Other countries need to follow the leadership of Kenya and South Africa and find ways to deliver this life-saving option today.
Young women, especially, are in desperate need of new prevention options they can control. While regulatory approval in these two countries should help accelerate access to oral PrEP, additional work is needed to ensure that millions of women, and men, from across the globe are able to benefit from a breakthrough that was developed expressly for them.
To elevate this from rhetoric to on-the-ground access and impact, a coordinated, global push to secure additional regulatory approvals, mobilize funding, raise awareness, generate demand and establish systems to get PrEP into the hands of all people most likely to benefit is needed. South Africa and Kenya’s experiences may offer a model for other nations, but there is no reason to wait. PEPFAR, the Global Fund and other key stakeholders (including Gilead Sciences and the generic manufacturers of TDF/FTC) should be working with countries to break down barriers to PrEP access within the next year.
For more information:
- Map: Regulatory Status of TDF/FTC for PrEP
- Release from South African Medicines Control Council
- South African PrEP Advocates Applaud the Approval of Truvada for PrEP and Call for Accelerated Action from South African Government to follow the WHO PrEP Guidelines
- The Desmond Tutu HIV Foundation Hails Approval of PrEP to Combat HIV Infections in South Africa
- Give Us ARVs So We Don’t Get HIV, commentary in the South African Mail & Guardian
- www.prepwatch.org
NIH unveils FY2016-2020 Strategic Plan
Developed after hearing from hundreds of stakeholders and scientific advisers, and in collaboration with leadership and staff of NIH’s Institutes, Centers, and Offices (ICOs), the plan is designed to complement the ICOs’ individual strategic plans that are aligned with their congressionally mandated missions [and] will ensure the agency remains well positioned to capitalize on new opportunities for scientific exploration and address new challenges for human health. You can find the NIH strategic wide plan here.
Human Rights = The End of AIDS
Written by AVAC staffer Micheal Ighodaro, this was first published by the International AIDS Society (IAS).
I was infected with HIV as an adolescent in the streets of Nigeria. As an openly gay man coming from a country like mine, I can tell you first-hand that without addressing human rights we cannot address HIV.
I knew I was gay when I was seven years old. My mum always knew but she always tried to hide it. I remember when I first asked her what the meaning of gay was she told me, “It means evil”. She locked me up in my room for a whole day for asking her what the meaning of gay was. She took me from church to church and to witch doctors who tried to cure me of what she believed I was.
She did this for three years and realized that all she had been doing was not working and that I really was gay. She and my dad hated me so much that my dad asked me to leave the house. I left home when I was seventeen and dropped out of my final year of high school because my dad was not going to pay my fees anymore. I traveled from city to city in Nigeria doing things that I am not really proud of, just so I could get the next meal.
Apart from Bisi Alimi—who was living in the UK and openly gay and HIV positive—no one was openly out as gay and living with HIV in Nigeria because of the stigma and discrimination. I had no idea that I had HIV or that I could contract HIV as a gay man due to lack of information. I lost some of my friends who would still be alive today if it weren’t for the stigma they experienced. It felt like no one was interested in us, gay men living with HIV. It seemed like we were almost left to die. Today, I am really happy for the treatment and prevention that is available now and that many gay men like myself, can live longer and healthier lives.
However, we still have over 79 countries where it is illegal to be gay, bisexual, transgender or intersex. These laws make it almost impossible for us to access HIV prevention and treatment services, which is a direct attack on our basic human rights.
LGBTI populations still face the highest risk of getting HIV in Syria and Afghanistan LGBTI populations face heightened discrimination from ISIS and other religious groups and in most cases are sentenced to death. Many of us are now refugees and asylum seekers in different countries.
As a person who has experienced the discrimination that comes from being gay in my own country, I must ask the question: How far have we gone in protecting the rights of vulnerable populations? This question remains to be answered and goes even beyond the legal rights of LGBTI—it’s about the rights of sex workers, trans diverse persons, people who use drugs, and people living with HIV.
All the recent scientific success we have had in the fight against HIV will come to nothing if we continue to have laws that take away the right of individuals to access life-saving care they need. On this International Human Rights Day, I ask that you stand with me in solidarity for all those who have experienced an attack on their human rights. We should and must do better.
Funding Opportunity: Risk of Adolescence and Injury in HIV Susceptibility (RFA-AI-15-058)
Purpose: To understand how reproductive maturation or injury alters adolescent mucosal environments at HIV susceptible sites in order to provide the safest and most efficacious biomedical prevention strategies (e.g., topical microbicides and Pre-Exposure Prophylaxis (PrEP), etc.). For more information click here.
A December Reading List
It’s the holiday season and in many parts of the world that means lists: of gifts, things to be thankful for, things that are needed and, sometimes, things to read. This week, which began with World AIDS Day, brought more reading material than we can possibly plow through between now and New Year’s Eve. So, in the holiday spirit, here’s a guide to some of the highlights from the new releases and who in your life might enjoy them most.
For the Walk-the-Talk Activist: As described in this post from AVAC’s P-values blog, this week’s International Conference on AIDS and STIs in Africa (ICASA) in Zimbabwe has brought bold advocacy and activism from women’s groups, sex workers, gay men and other men who have sex with men, trans-diverse people, women living with HIV and many other groups. Unfortunately, there have also been rights violations and harassment of people, including many individuals from “key populations”. Our blog provides first-hand accounts and info on how UNAIDS responded.
For Anyone with a “Wonder Woman” in their Lives: An AVAC blog on the new Innovation Challenge for the DREAMS Initiative, a program aimed at adolescent girls and young women. The Innovation Fund is designed to infuse additional money into bold programs—and bring in new private-sector partners.
For the Implementation Advocate (who can live without photo captions): The new World Health Organization policy brief on what’s new in the second edition of the Consolidated Guidelines on the Use of Antiretrovirals (ARVs). If you feel like you’ve missed the second edition (the first, issued in 2013, can be found here), fear not. The full guideline still isn’t out—WHO has said to watch for it in 2016. But this policy brief gives important highlights and expands on the early release guideline on PrEP and when to start ART, which came out in September.
The newest document highlights what’s truly new. In the ART section, WHO, for the first time, advances a “differentiated care” approach that sees people living with HIV in categories other than CD4 cell count, and pregnant or not. The document begins to map what it would take to deliver services in a world where people who are unstable on ART receive one type of intervention, those who are healthy and newly diagnosed, and so on. It won’t be easy—but it wouldn’t be possible without this type of detail.
If you’re looking for captioned photos, this is a document to avoid: pictures of people apparently from low- and middle-income countries abound, but with no identifiers, and it’s hard to tell when, where or why the pictures were taken. In a document that recommends looking closely at each individual and his or her reality, the illustrations would be a great place to start.
For the Two-Briefs-Are-Always-Better-Than-One Advocate and the PrEP-Curious Reader: A two-page policy brief on PrEP from WHO that’s short and to-the-point. This is a great handout to show to people who want just the facts on why WHO now states “#offerprep” as a strong recommendation.
For the Number Cruncher (who likes photo captions): Volume Four of the One Campaign’s “Unfinished Business” report on global financing for HIV manages to be both clear, simple and comprehensive about who is spending what—at the country level and in the private sector. It also features country-specific pages and recommendations, trend analyses and clear advocacy “asks” for the Global Fund, African countries—and more. Fans of captions will be happy to see that every picture has an explanation of who is shown, where they are from and what they do.
For the Unsatisfied Realist: Treatment on Demand for All, a policy analysis paper by Health GAP and partners that maps the gaps between policy and reality when it comes to ART access worldwide. Noting that fewer than 1 out of 10 people living with HIV worldwide live in a country where immediate ART (as recommended by the WHO) is current policy, the report describes the state of, and remedies for, this great global divide.
For the Precision-Minded PrEPster: The full New England Journal of Medicine article presenting the findings from the IPERGAY trial that evaluated “on-demand” PrEP in gay men in France and Canada. Steer clear of the press release and subsequent media which suggests that the study found evidence that coitally-related dosing is effective and head straight for the discussion section which clearly states that the only conclusion IPERGAY can draw is that four pills per week provides high levels of protection in this study population.
Evaluation of the levels of drug needed to provide protection in the context of anal sex back up this conclusion—which, for now, is clear evidence that a daily PrEP regimen can be forgiving of a few missed doses for gay men and transwomen. Now is not the time to shift from the message that a pill a day provides protection. For more on PrEP’s pipeline and interpretation of the IPERGAY results, check out the two articles in POZ magazine.
Pour les Francais et leurs Amis: For the French and those who love them, lift a glass for resilience in the face of terror and another for the announcement from French Minister of Health, Marisol Touraine that will bring government-subsidized PrEP to those who need and want it.
For the Speed Readers: Ending the HIV-AIDS Pandemic—Follow the Science, an editorial in the New England Journal of Medicine. In it, Anthony Fauci and Hilary Marston of the US NIH need just over 1,000 words to summarize the science that has defined progress in the epidemic.
Happy reading—and let us know what’s on your list!
Outright Activism as ICASA 2015 Starts with Violations and Silence on Key Populations
Many activists arriving at the airport in Harare, Zimbabwe for the International Conference on AIDS and STIs in Africa (ICASA) saw familiar faces, greeted far-flung comrades and headed for the passport desk and baggage claim expecting this meeting to be like others in the past—a chance to share strategy, recharge and set priorities for the coming year in dialogues led by and for Africans and their allies.
Instead, even before exiting the airport, things took an unexpected turn: sex workers, gay men and transgender women and even activists who just “looked different” reported having materials confiscated, being personally detained, having their passports held and being charged duties to reclaim their posters and educational materials.
At the conference venue, trouble continued. UNAIDS head Michel Sidibé opened the conference with remarks that, while stirring, made no mention of “key populations”, including gay men and other MSM, transwomen, sex workers and others. This prompted a sign-on statement asking Dr. Sidibé to “Walk the Talk”, of the messages of support he gives these groups behind closed doors.
Dr. Sidibé and UNAIDS listened, and when he officially opened the Community Village on November 30th, he said, “Key populations are helping us to break the conspiracy of silence.” The full statement UNAIDS made on this issue can be read here.
Unfortunately, discrimination and challenges have continued at the very gathering that should, and indeed must, be a safe space for everyone working on HIV. Here are some additional voices from the frontlines:
Micheal Ighodaro (AVAC): Coming here I was expecting [ICASA] to be the standard it was before. At the ICASA conference in Addis, we were allowed to come and go freely. Here, materials were detained and MSM and transgender people were questioned regarding the content of their materials. My materials were detained at the airport for the Key Populations Preconference. While that issue has been resolved, ICASA organizers did not apologize at the opening for what everyone has had to go through simply to get their materials to the conference. I thought most ICASA organizers would have known better.
Regarding key populations at the conference, people weren’t sure it would be safe to attend. People are more scared after all that they are seeing. I met some friends following a day of sessions and the restaurant made an announcement soon after we’d arrived stating, “No more sex workers here.” No one I was with was holding hands or doing anything to attract attention. I’m more concerned and angry, I was expecting to see better both at ICASA and in the country. We tried to have t-shirts printed with #WalktheTalk; however, the printer here in Harare refused to print them since some of the designs include “MSM” and “sex worker” on them.
Carolyn Njoroge (Kenya Alliance of Sex Workers): On arrival to Harare there was a lot of screening and questions, asking what we came to do, if we were coming for ICASA as part of a group. They opened our bags and everything we had that included the words, “sex worker”, including my poster presentation on advocating for rollout of PrEP for male and female sex workers, our t-shirts and all other materials, was confiscated. Additionally, three transgender people were locked in a room and their passports were taken away. We reached out to the African coordinator for ICASA and they were eventually released.
We were told that the laws in Zimbabwe do not allow that sex work can be practiced—according to “regulations and morals”. All our materials were left at the airport and we had to pay to get them released. They were finally released this morning [Monday], after originally being told we could not bring them into the country but could only get them on our way out of the country.
When we got here this morning, the conference organizers had removed everything that said “sex workers” from our booth in the Community Village and told us we had to call ourselves, “Key Population S” and “Key Population M” [for MSM]. After we said no, they decided we did not need to do this, but did move us to the back tent. [The Village is a series of three tents connected through small walkways. The Sex Worker Zone and MSM Zone are in the last tent].
At the hotel, we gave our passports when checking in and I was asked what I had come to do. I told them I was with ICASA, and they asked with whom. I told them I was supported by the African Sex Workers Alliance and am a sex worker from Kenya. They told me the hotel had regulations—no wearing of miniskirts and shorts past 6:00 pm, no looking at people like you want to solicit, no wearing indecent clothes, we can’t go out late and come back late. When we booked at the hotel they saw who we are affiliated with, why did they agree to let us stay there?
Police arrested a male sex worker at the Sex Worker Zone booth. The officer was not wearing a uniform and came in with the purpose of getting a sex worker to agree to sex. We are scared and trying to travel together to and from the conference, or stay in our hotel rooms.
If the government of Zimbabwe agreed to host ICASA, they knew it would bring people from diverse populations. Why did they agree to host?
What can you do?
- Become an ally to LGBT and sex worker groups in your country—contact AVAC for more information.
- Email anyone you know at ICASA asking them to call on speakers to state, in their opening remarks: “I stand in solidarity with African key populations: sex workers, men who have sex with men, trans diverse persons, people who use drugs and all people living with HIV. Protecting their rights is essential to the fight to end AIDS.” (This statement was developed by civil society groups representing key populations.)
New Funding for DREAMS, New Targets for Advocacy
World AIDS Day brought a flood of announcements—and for advocates who’ve been following the DREAMS initiative—a joint venture of PEPFAR, the Bill & Melinda Gates Foundation and Girl Effect (the Nike Foundation)—there was news of note.
Speaking at the International Conference on AIDS and STIs in Africa (ICASA), in Harare, Zimbabwe, Ambassador Deborah Birx, head of the PEPFAR program, announced the details of an “Innovation Challenge” fund that would bring new money and new partners to the initiative, which is focused on bringing down rates of HIV in adolescent girls and young women.
Ambassador Birx announced that the DREAMS Innovation Fund would combine US$80 million in PEPFAR funds (a new allocation from within the existing budget) with US$25 million from new private sector partners Johnson and Johnson and ViiV, as well as support from Gilead, with a specific focus on providing PrEP as part of the DREAMS country plans.
The precise plans for how the Innovation Funds will be disbursed, including timelines for applications to the fund, framing of the requests for proposals, and so on haven’t been revealed yet. A fact sheet on the Innovation Challenge can be found here.
The next step for advocates? Keeping up the pressure on OGAC and PEPFAR country offices to ensure that civil society coalitions are engaged in both Innovation Challenge planning and overall DREAMS implementation. With dialogues happening right now at ICASA on this very topic (follow @hivpxresearch for the latest), this is already in the works. Not in Harare? Be in touch to get involved.