Gilead Sciences Submits sNDA to FDA for Once-Daily Descovy for HIV Pre-Exposure Prophylaxis — Gilead Sciences announced that the company has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for PrEP to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV. There is an anticipated review time of six months.
To Halt HIV, Advocates Push For PrEP Outreach To Black Women — In 2013, not quite a year after the Food and Drug Administration approved the drug Truvada for HIV prevention, a coalition of 50 experts in HIV and women's health called on US public health agencies to promote the pill and its approach, called pre-exposure prophylaxis, or PrEP, explicitly to women.
Everything You Need to Know About HIV and PrEP — PrEP can be a valuable tool for women of all experiences who either can’t or don’t want to negotiate condom use with their partners. In July of 2012, the Food and Drug Administration approved Truvada, a daily pill, for HIV prevention among adults who are at high risk of getting the infection. Earlier this year, the FDA approved Truvada for PrEP for adolescents. People aged 13 to 24 accounted for 21 percent of new infections in 2016 and the majority of those infections were among black and Hispanic youth.
Informal PrEP: An emerging need for nomenclature — Different expressions are used to describe the process of informal access to antiretroviral drugs for PrEP: “informal use”, “informal PrEP”, “off-label PrEP”, “non-prescribed PrEP”, “DIY PrEP”, and “wild PrEP”. This lack of consistent nomenclature makes it difficult to develop an accurate understanding of the nature of the process and its public health implications. To improve consistency for future research and public health initiatives, this process should be referred to as informal PrEP.
Highlights of HIVR4P 2018 — Laura Fitch (AVAC) presented data from AVAC's global PrEP tracker, showing that in the first quarter of 2018, 309,525 people were initiated on oral PrEP. The tracker captures data from ongoing and planned oral PrEP demonstration projects, implementation initiatives and national programmes, and probably underestimates the number of people beginning oral PrEP, particularly in Asia.
PrEPcost.org Launches - This site matches individuals who are interested in PrEP to eligible health plans and provides comparative pricing. PrEPcost.org is designed for both PrEP users and health care providers to make it easy to navigate the insurance options and find the best plans available.
PrEP Spreads Across Africa – Slowly - Pilot PrEP projects have been underway in some African countries for several years. But it has only been since late 2017 that some countries have started serious PrEP availability programmes for wider populations.
OPTIONS Consortium Launches PrEP Communications Accelerator - The PrEP Communications Accelerator aims to fast-track development of strategic communications planning for health professionals by aggregating market research, strategic recommendations and tactical considerations for a range of PrEP-ready settings.
Rising Cost Of PrEP To Prevent HIV Infection Pushes It Out Of Reach For Many - Public health officials are expanding efforts to get the HIV prevention pill into the hands of those at risk, in a nationwide effort to curb infections. But the officials are hitting roadblocks — the drug's price tag, which has surged in recent years, and changes in insurance coverage that put a heftier financial burden on patients.
FDA Approves Truvada as PrEP for Adolescents at Risk for HIV - The US Food and Drug Administration has expanded the approval of Truvada as pre-exposure prophylaxis (PrEP) against HIV to include adolescents. Truvada was approved as an HIV prevention method in 2012 but only for individuals age 18 and older. The new approval expands this indication to include adults and adolescents at risk for HIV.
Early PrEP Uptake in Africa Study Gives Support for Possibility of Wider Acceptance - New findings show that nearly a fifth of adults whose risk for HIV infection made them eligible for free PrEP started taking the drug within 30 days — according to a study examining the impacts of health interventions across communities in two East African countries. The study’s authors conclude that this provides further evidence that widespread roll out of PrEP to individuals at high risks for infection across resource-limited communities is feasible.
A Daily Pill Can Prevent HIV Infections. Why Don’t More People Use It? - There’s no question that a simple regimen of a single daily pill can slash HIV infections in people at risk. But although millions of people around the world could benefit, only 200,000 are prescribed PrEP, and 75 percent of them are in the United States. The disparity was the focus of anguished discussions this week at the largest annual US HIV/AIDS conference.
Mapping PrEP: First ever data on PrEP users across the US - The Center for AIDS Research at Emory University's Rollins School of Public Health produces interactive online maps with visualized data on different aspects of the US HIV epidemic, and its prevention and treatment response, at AIDSVu.org. This set of maps and statistics focuses on PrEP use nationally and by state from 2012-2016.
Put the Power in Your Hands - This TEDx Talk by Dr. Nneka Nwokolo, an HIV consultant working in the United Kingdom, tells a story of PrEP’s potential with references to a large documented decline in new infections at key clinics.
What is PrEP - Planned Parenthood Video - Planned Parenthood has published this video explaining how to take PrEP correctly and consistently, and how it differs from PEP (post-exposure prophylaxis). Planned Parenthood released the video in conjunction with National Black HIV/AIDS Awareness Day, on February 7.
New Zealand to Introduce PrEP for Less than Two Dollars a Month - K-based, LGBT-focused PinkNews.co.uk reports New Zealand's decision to publically fund prescriptions of PrEP for those considered to be at high risk of exposure. According to the story, New Zealand recorded its highest number of new HIV diagnoses in 2016 since the AIDS crisis began in the 1980s. With public funding the cost of prescriptions is expected to be less than USD $2.
Paperwork Begins for Possibly Introducing HIV Prevention Pill (Guyana) - A regional publication from Guyana, Demerara Waves, reports on considerations to bring PrEP to Guyana. The Society Against Sexual Orientation Discrimination (SASOD) is gathering required documentation for the ministry of public health and a demonstration project to administer PrEP to gay men and men who have sex with men is possible as early as 2019.
British Columbia to Fund HIV-Prevention Drug - This article by the Canadian Broadcasting Corporation reports on a decision by the government of British Columbia to cover the cost of oral PrEP for eligible populations. The policy goes into effect January 1, 2018 and sources credit the expanded coverage to an agreement that allows the provincial government to secure generic Truvada.
Experts Concur that Event-related Oral PrEP Probably Won’t Work for Women - Presenting at the International AIDS Society Conference, Bob Grant said that although that there was abundant evidence that PrEP did protect cisgender women from infection, it looked like six to seven doses a week, i.e. daily PrEP and good adherence, would be needed to fully protect them.
Health Dept to Place New HIV Prevention at Uni - iafrica.com reports on a decision by South Africa’s Department of Health to roll out PrEP to its university system. An initiative of the Higher Education and Training HIV/AIDS Programme (HEAIDS) is making PrEP available to students for the first time. PrEP will be available in 11 clinics at seven universities. Up to now, government programs have been aimed at reaching sex workers and men who have sex with men.
Government Rolls out Drug to Reduce HIV Risk - The New Vision reports that the Ugandan government is rolling out oral PrEP to public health facilities across the country. PrEP will be first available at seven public health facilities, to be rolled out across the country when resources allow.
Namibia Approves the Use of PrEP in HIV Prevention - The Namibia Ministry of Health and Social Services 2016 National Guidelines has expanded the provision of PrEP to individuals at extensive risk of HIV acquisition, as per WHO prevention guidelines released in 2015.
Vietnam: Oral HIV pre-exposure service launched - The Vietnam Administration for AIDS Control launched an oral PrEP prescription service this past March. This pilot program will run until September 2018, when it will be re-evaluated by the Ministry of Health.
PrEP is Approved in Scotland - The Scottish Medicines Consortium announced that it had accepted tenofovir disoproxil/emtricitabine (TDF/FTC – Truvada) for use within the Scottish National Health Service as pre-exposure prophylaxis (PrEP) to prevent HIV infection.
PrEP Should be Given to All Breastfed Babies, Researchers Say - An international group of researchers involved in the ANRS 12174 randomised controlled trial of pre-exposure prophylaxis (PrEP) for infants say that it is high time we started giving PrEP to all breastfed babies of HIV-positive mothers in countries where the likelihood of transmission via breastfeeding remains significant.
Tshwane Men to Get the HIV Prevention Pill - Men who have sex with men will soon be able to get the HIV prevention pill in Tshwane. As of April 1, men who have sex with men will be able to get PrEP from a Hatfield clinic in central Pretoria. The clinic is run by health advocacy organization OUT LGBT Well-being, which already provides HIV prevention services, such as a needle exchange program, to people at high risk of HIV.
Oral PrEP Works Well in Women With Abnormal Vaginal Microbiota - POZ reports on findings that oral PrEP works for women even with an abnormal vaginal microbiome. The research address concerns raised by some studies that suggested vaginal gels used as PrEP were not as effective among women with a microbial imbalance in the vagina.
New York Clinic Outlines How to Improve Uptake of PrEP by Transgender People - Rolling out PrEP right. aidsmap reporter Roger Pebody recently published a careful look at how one New York City clinic brought PrEP to a transgender community. Pebody’s story documents the steps taken by the Callen-Lourde Community Health Center to navigate the fault lines of a marginalized people and deliver a potent tool for HIV prevention.
PrEP Introduction for Adolescent Girls and Young Women - In a commentary in Lancet HIV, authors Mathur, Pilgrim and Pulerwitz from the Population Council propose a framework that outlines the range of factors and actors to consider when designing PrEP introduction strategies for adolescent girls and young women.
HIV Prevention Drug Truvada Won't Be Subsidised in Australia - A major Australian newspaper reports that the nation's drug funding panel has ruled PrEP will not be funded by taxpayers in Australia this year, The department of health announced that the price set by the drug's sponsor, Gilead Sciences, was too high.
PrEP Use Is Rising Fast in US, But Large Racial Disparities Remain - More than 49,000 people in the US have filled prescriptions for Truvada for PrEP at retail pharmacies, according to the results of a survey by Gilead Sciences. Among PrEP users with available data, most were white gay men. Black people used PrEP much less often, despite having the highest rates of HIV infection.
Oral HIV Help for Sex Workers - The South African government launched the first phase of its PrEP access program with clinics that will provide access to all interested individuals—with a focus on sex workers.
HIV Prevention Pill Approved in Australia - Truvada, which is used as a form of pre-exposure prophylaxis (PrEP) to prevent HIV, has been approved in Australia by the Therapeutic Goods Administration, the national regulatory authority.
PrEP Pricing Problems - James Krellenstein and Jeremiah Johnson write in the April issue of TAGline about the high cost of PrEP as a deterrent to increased uptake. They discuss problems with Gilead’s medical and co-pay assistance program (MAP/CAP), the company’s reluctance to prioritize PrEP and how Gilead is “profiting from its PrEP monopoly”. The article ends with recommendations for Gilead which include increasing CAP contribution and aggressively promoting CAP and MAP.
England's PrEP Policy in Disarray After NHS U-turn - Activists, individuals at risk of HIV and clinicians in the UK have reacted with anger to an official U-turn on provision of HIV pre-exposure prophylaxis (PrEP). Activists are calling upon UK government ministers to intervene and reverse the decision; a letter-writing campaign and petition are both open.
UK NHS Punts on PrEP: Advocates call for decision reversal and wide access to PrEP - As reported in AVAC's blog, P-Values, long-time activist editor Gus Cairns wrote a piece highlighting the UK National Health Service’s silence around PrEP. Just hours later, NHS England released a statement announcing that a PrEP policy would not be included in the NHS’ June decision-making process as originally expected. HIV groups in the UK condemned the announcement.
HIV Pre-Exposure Pill a Lifeline for Sex Workers - IOL News reports that The South African Department of Health and the South African National AIDS Council (SANAC) are expected to announce that at least 3,000 sex workers will be eligible to begin taking PrEP. In addition, all HIV-positive sex workers will be eligible to start HIV treatment as soon as they test positive for the virus, regardless of CD4 count.
Vaginal Ring with Drug Lowers HIV Rates in African Women - A flexible and inexpensive ring that is inserted into the vagina, where it slowly releases an antiviral drug, helped protect African women against contracting HIV from their sexual partners, researchers said in reports on two major studies that included more than 4,500 women.
New HIV prEP Studies Will be a Challenge, Statisticians Warn - Two statisticians involved in the PROUD and iPrEx trials of PrEP warn that future trials to test new PrEP drugs and formulations may be extremely difficult to design. David Dunn of the UK Medical Research Council and David Glidden of the University of California at San Francisco say that statisticians will need to choose and analyze their trial populations very carefully if they wish to be able to demonstrate meaningful results.
When Condoms Aren't Enough: to PrEP or not to PrEP? - Siya Mnyanda, a young South African, wrestles with the benefits and potential risk of taking PrEP. In an op-ed for Health44, he writes about why condoms are not enough in preventing HIV and concludes that PrEP is important to reduce HIV transmission.
When Condom's Aren't Enough: to PrEP or not to PrEP? - Siya Mnyanda, a young South African, wrestles with the benefits and potential risk of taking PrEP. In an op-ed for Health44, he writes about why condoms are not enough in preventing HIV and concludes that PrEP is important to reduce HIV transmission.
Dramatic Increase in Preexposure Prophylaxis Use Among MSM in Washington State - Using data from an annual survey conducted at the Seattle Pride Parade (2009-2015), authors of an article published in AIDS found that PrEP awareness and use among MSM in Seattle, Washington was high in 2015. In 2012 to 2015, among high-risk MSM, PrEP awareness increased from 13 percent to 86 percent and PrEP use increased from 5 percent to 31 percent.
Approval of Truvada a Game Changer in Anti-HIV/AIDS Effort - Wanjiru Mukoma of LVCT Health applauds the recent approval of Truvada by Kenya and stresses that developing guidelines, fighting stigma and collaborating with stakeholders is key to an efficient integration of PrEP in health services.
When Can We Expect PrEP 2.0? - Benjamin Ryan of POZ discusses what's in the PrEP pipeline, looking forward to long-acting injectables and drugs less toxic than Truvada.
Why Don't Women Know About This Lifesaving Drug? - 1 in 4 people living with HIV in the United States are women. Naveen Kumar of Refinery29 discusses why more women aren’t talking about PrEP—despite the fact that it's been FDA-approved since 2012—and the potential PrEP has to improve women’s health.
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".
1 In 4 Gay Men Should Take The Pill That Prevents HIV, CDC Says - A report released by the US CDC finds that roughly 1.2 million people would benefit from PrEP based on their reported rates of otherwise unprotected risk behavior. That’s about 60 times higher than current estimates, which suggest about 21,000 people take the drug.
There's A Drug That Prevents HIV. Let's Use It. - TIME Magazine staff writer Alice Park discusses new data published in JAMA, PrEP’s “image problem”, and why now is the time for cities and states to follow San Francisco’s lead and make PrEP widely available.
European AIDS Clinical Society - The European AIDS Clinical Society (EACS) has released EACS Treatment Guidelines Version 8.0 that for the first time includes a recommendation on PrEP. EACS Guidelines favor use of PrEP in MSM, and include an “on demand” IPERGAY dosing schedule for MSM at high risk.
When Will Europe Get PrEP? - Demand for access to PrEP in Europe is growing, but it is still not licensed or funded by any national or regional governments in Europe. All this and more was discussed at a session at the 15th European AIDS Conference.
A Wonder Drug to Prevent HIV (and Why More People Aren't Taking It) - An article in the BloombergView argues that slow uptake of PrEP in America is related to a lack of focus on HIV prevention in the health care system. Truvada is currently not mentioned in the American Academy of Family Physicans’ clinical recommendations to prevent HIV. The article argues that getting more people on PrEP will take a coordinated effort by both physicians and local governments to shift habits and decisions in the health-care system.
Accessibility to Sexual Health Resources Among Diverse Populations - Steph Auteri, writing for aasect, links a New York Times article on a highly successful IUD promotion campaign in the US to what it will really take to address women’s sexual and reproductive health needs, including commentary on PrEP from IRMA’s Jim Pickett and AVAC’s Mitchell Warren.
Millions More Need HIV Treatment, WHO Says - The World Health Organization issued sweeping new guidelines on Wednesday that could put millions more people on HIV drugs than are now getting them. The recommendations could go a long way toward halting the epidemic, health officials say, but would cost untold billions of dollars not yet committed.
ITM Launches Study on a Preventative Drug for HIV - The Institute for Tropical Medicine (ITM) in Antwerp has launched the Be-PrEP-ared study, the first Flemish research project on the applicability of preventative HIV medication. The researchers hope that the study, which focuses on gay men, can help to reduce the high number of new HIV infections among the target group.
Movie stars and athletes say #BlackLivesMatter means stopping HIV - The team behind the film Blackbird — along with several notable others like former football player Wade Davis, actress Mo'Nique, filmmaker Patrik Ian Polk — have joined forces with Alabama’s largest HIV organization to talk about PrEP and its potential benefit for young black gay and bi men.
TDF2 OLE: High PrEP adherence results in zero infections - Heterosexual men and women in Botswana were highly adherent to pre-exposure prophylaxis, resulting in no new HIV infections during the course of 12 months, according to results from the the CDC’s TDF2 open-label extension trial.
PrEP is not linked to greater risk for depression - A new paper out of the iPrEx study—a randomized, placebo-controlled trial of daily oral HIV pre-exposure prophylaxis (PrEP) in men and transgender women who have sex with men—reported no link between taking Truvada for oral PrEP and experiencing depression.
South African AIDS Activists Demand PrEP NOW - 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.