AHF Launches Anti-PrEP Ad Campaign

The combative and controversial AIDS Healthcare Foundation is launching a print ad campaign against the use of Truvada as a daily HIV preventive. Via press release:

AHF’s ‘PrEP Facts’ ad campaign educating the public about adherence issues and PrEP initially started running this week in a few newspapers, magazines and online outlets in California and will continue and expand to six outlets in California and five news outlets in South Florida over the next week. AHF’s campaign also comes on the heels of recent—and what AHF believes are misguided—recommendations by both the Centers for Disease Control (CDC) and World Health Organization (WHO) for the widespread scale up and implementation of the problematic HIV prevention strategy.

“The eight major studies show the scientific data do not support the large-scale use of Truvada as a community-wide public health intervention to prevent transmission of HIV,” said Michael Weinstein, President of AIDS Healthcare Foundation. “Medication adherence is the primary problem: Even in carefully monitored clinical trials, in which people were counseled monthly, had blood samples drawn and were even paid to participate, many study participants simply did NOT take Truvada every day as prescribed. As such, we want the public to know that the government-sanctioned widespread scale up of PrEP appears to be a public health disaster in the making.”

The ads will run in numerous LGBT, mainstream, and alternative papers including Frontiers, South Florida Gay News, Los Angeles Daily News, Miami New Times, Hotspots, Oakland Post, and Florida Agenda.

NEW YORK: State Endorses Truvada For Daily Use As HIV Preventive

The New York state Department of Health has officially endorsed daily use of the Gilead medication Truvada for the prevention of HIV infection.

After months of anticipation, the Health Department's AIDS Institute released thorough clinical guidelines for pre-exposure prophylaxis, commonly known as PrEP, which is a daily dose of HIV medication that people who are HIV-negative but at-risk of contracting the virus can take to drastically reduce their chance of infection. The drug, known by its prescription name Truvada, can reduce the chance of infection by as much as 73 percent, according to studies funded by the Bill and Melinda Gates Foundation. However, the AIDS Institute stressed that PrEP alone was not enough to prevent new infections. "PrEP should not be offered as a sole intervention for HIV prevention. PrEP should only be prescribed as part of a comprehensive prevention plan," the report says.

Preventive use of Truvada, while supported by most HIV/AIDS groups including ACT UP and the San Francisco AIDS Foundation, remains controversial. In particular, the Los Angeles based AIDS Healthcare Foundation has long battled against the preventive use of Truvada. In July 2012, when the drug was first approved for daily preventive use, the AHF accused both Gilead and the FDA of "negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people." Last August the AHF declared victory in their Freedom of Information Act request which sought proof that Gilead colluded with the FDA on "what to say to get their unfavorable drug trial results spun in such a way that the FDA deemed them sufficient to approve the drug."

Truvada retails at an annual cost of up to $14,000 and its use as a preventive is not yet covered by all insurance plans. Today's guideline from the state recommends that AIDS groups focus on identifying the most high-risk persons who would benefit from its daily use.

FDA Approves 4-In-1 HIV Med

The FDA has approved Gilead's latest combination once-a-day HIV pill which has been known as "the Quad." Via FDA press release:

Stribild contains two previously approved HIV drugs plus two new drugs, elvitegravir and cobicistat. Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs and is used to prolong the effect of elvitegravir. The combination of emtricitabine and tenofovir disoproxil fumarate, approved in 2004 and marketed as Truvada, blocks the action of another enzyme that HIV needs to replicate in a person’s body. Together, these drugs provide a complete treatment regimen for HIV infection. “Through continued research and drug development, treatment for those infected with HIV has evolved from multi-pill regimens to single-pill regimens,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “New combination HIV drugs like Stribild help simplify treatment regimens.”

RELATED: The FDA recently approved Gilead's Truvada as a daily HIV preventive for high risk groups. As noted above, Truvada is part of the newly-approved medication. Last month the FDA also approved an in-home HIV testing kit. That item reportedly comes on the market in October.

Four-In-One HIV Med News

Gilead has announced the results of Stage 3 clinical trials of "the Quad," which would be the world's first four-in-one daily HIV pill. The Quad contains two new (and not yet FDA approved) drugs: the integrase inhibitor, Elvitegravir, and Cobicistat, which is meant to mitigate the side-effects of Elvitegravir.

Via press release:

“These data show that the Quad is as effective [as Atripla] as a current standard of care in HIV therapy. The safety profile of Quad was also comparable to that of Atripla, and was better tolerated in terms of key neurological side effects,” said Paul Sax, MD, Clinical Director of the HIV Program and Division of Infectious Diseases at Brigham and Women’s Hospital, Boston, and principal investigator of Study 102. “Based on these results, I believe the Quad could represent a potentially important new treatment regimen for a wide range of HIV patients initiating therapy.”

Gilead also produces Atripla. Both Atripla and the Quad contain Truvada, which is under consideration as a daily pre-exposure prophylactic (PReP) for the uninfected.

Reuters has more:

The safety data, presented here on Wednesday at the Conference on Retroviruses and Opportunistic Infections, showed that patients on Atripla had significantly higher rates of dizziness, abnormal dreams, insomnia and rash, compared with the Quad. The experimental pill did result in higher rates of nausea, 21 percent vs 14 percent. The study found that at 48 weeks of treatment, 88 percent of Quad patients, compared with 84 percent of Atripla patients, achieved target levels of HIV virus.

As millions of patients are well into their second decade of daily HIV therapy, we'll see more of this focus on refining the treatments to reduce their immediate and long-term side-effects.

FDA Approves New HIV Med

Yesterday the FDA approved the second all-in-one daily combination pill for the treatment of HIV infection. The first such medication, Atripla, has been on the market for several years.

Complera, a complete single-tablet regimen containing Janssen Therapeutics’ Edurant (rilpivirine) and Gilead Sciences’ Viread (tenofovir) and Emtriva (emtricitabine), was approved August 10 by the U.S. Food and Drug Administration (FDA), according to an announcement by Gilead. Complera, the second all-in-one fixed-dose combination tablet for people living with HIV, is approved for those starting antiretroviral (ARV) therapy for the first time.

The new combination pill is not yet available in Europe.

Good News/Bad News For Gilead

It's a complicated turn of events for Gilead, the maker of HIV drug Viread. The 9th Circuit Court has reinstated a securities class action suit against the drug maker which claims that Gilead had misled investors about the demand for Viread.

The suit charges that Gilead fostered demand for Viread by using improper marketing such as "aggressively promoting off-label uses." Among the off-label uses were "marketing to patients co-infected with Hepatitis B." The suit (PDF) claims that 75% - 95% of Viread sales came from such off-label sales.

Little Viread is sold as a stand-alone drug today as it is most commonly prescribed as part of the combination pills Atripla and Truvada. However, the drug has been studied in recent years as a possible daily HIV preventive, with one AIDS activist even calling for it to be "coformulated with Viagra."

However, on the same day that the above lawsuit was green-lighted, comes word that the FDA actually HAS just approved Viread as a treatment for chronic Hepatitis B in the United States. The drug is already approved for such use in Europe. So Gilead wins by having one of the few drugs approved to treat Hep B, but loses for how they got to that approval. I think. Insiders?