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Letter to FDA Regarding Application for Descovy as Pre-Exposure Prophylaxis for HIV

TAG and PrEP4All sent this letter to Dr. Debra Birnkrant of the FDA, outlining and expressing our serious concerns about Gilead’s supplemental New Drug Application for Descovy (FTC/TAF) as HIV-1 preexposure prophylaxis (PrEP). There are several specific recommendations in the letter for this approval process, including recomending that the FDA convene a public meeting of the Antiviral Drug Advisory Committee.

Published
17 April 2019
From
Treatment Action Group
Sticker Shock: PrEP Is Not Cost-Effective at Current Price, Health Economists Find

For years, the U.S. HIV prevention community has known that pre-exposure prophylaxis (PrEP) is prohibitively expensive for many patients who need it. Now, new research presented at the 2019 National HIV Prevention Conference (NHPC) in Atlanta finds that not only is PrEP expensive for individual patients, it's also not cost-effective for the health system as a whole.

Published
09 April 2019
From
The Body
Gilead Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Once-Daily Descovy® for HIV Pre-Exposure Prophylaxis

Filing Supported by Data Demonstrating Non-inferiority Compared to Truvada® Coupled with Bone and Renal Safety Advantages in People at Risk of Sexually Acquired HIV Infection

Published
08 April 2019
From
Gilead press release
Op Ed: On-Demand PrEP Strategies Work Despite Recent Contraction

Damon L. Jacobs: An Australian man may have contracted HIV while practicing on-demand PrEP — but that changes nothing. PrEP is exceedingly effective, and an essential part of plans to end the epidemic.

Published
30 March 2019
From
HIV Plus
An Australian Doctor Has Some Answers About PrEP User With HIV

A 27-year-old Australian man, Steven Spencer acquired HIV while practicing PrEP as an on-demand strategy. We reached out to Dr. Darren Russell, clinical adviser for Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine. Dr. Russell consulted and advised on Spencer's specific case, and agreed to share previously unmentioned facts that have not been reported elsewhere.

Published
26 March 2019
From
HIV Plus
PrEP Pricing Is the Elephant in the Room at the CDC National HIV Prevention Conference

Pre-exposure prophylaxis (PrEP) was supposed to usher in an end to the HIV epidemic. Now, seven years after its approval, it's clear that the once-daily pill has failed to reach the very patients who need it most. For veteran HIV researcher Michael Saag, M.D., with the University of Alabama at Birmingham, the reason is simple: PrEP is too expensive.

Published
24 March 2019
From
The Body
'In complete shock': Sydney man contracts HIV despite taking PrEP drug

Steven Spencer, 27, tested positive for HIV in December, despite diligently using PrEP "on demand" before and after sexual encounters in line with the advice of doctors. "What happened to me doesn’t change the fact that PrEP is still the most powerful HIV preventative we have ever had," said Mr Spencer, one of the first men in Australia to start taking the medication more than five years ago.

Published
22 March 2019
From
Sydney Morning Herald
On-Demand PrEP With TDF/FTC Not Associated With Clinically Relevant Decline in Kidney Function

On-demand pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) is not associated with a significant relevant in kidney function, especially among young people with low pill use and high baseline estimated glomerular filtration rate, investigators in France found.

Published
20 March 2019
From
Contagion Live
Jean-Michel Molina, MD, on Biomedical Failures of PrEP: Rare, But Serious

"There are multiple reasons for PrEP failures and they could be at any point in the PrEP continuum of care. From people who may not use their pills as recommended, to a health care system that is not able to provide access to PrEP for people in need, it could be also the physicians who are not ready to prescribe PrEP or not aware that they could use PrEP for preventing HIV in high-risk patients. It could be also the test that we use sometimes that are not able to detect acute HIV infection. And, if you start PrEP in someone with acute HIV infection you will see more resistance."

Published
14 March 2019
From
Contagion Live
Gilead's Descovy snared its PrEP data, but can it stand up to Truvada generics?

Gilead Sciences has the data it’ll need to start transitioning patients taking Truvada for PrEP over to Descovy, a drug with a longer patient life. But once Truvada generics hit, it might be a different story.

Published
14 March 2019
From
FiercePharma
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Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.