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Injectable PrEP? It May Be Available Sooner Than You Think

People who use Truvada as Pre-exposure Prophylaxis (PrEP) and those already infected with HIV may someday be able to say goodbye to their daily pill regimen.

Research presented late last month at the 16th Annual Workshop on Clinical Pharmacology of HIV & Hepatitis C Therapy in Washington, D.C., shows promise for a monthly, or even quarterly, injectable dose of Cabotegravir.

“The moment I saw the first poster on GSK744 at the IAS Washington, D.C. conference in July 2012, I immediately recognized this was a key presentation, this was the sleeper presentation at the conference,” said Jules Levin, executive director of NATAP, who presented the update. “This would be a very major development in HIV treatment and PrEP. Imagine – HIV treatment delivered once every one to three months by injectable, and PrEP, every one to three months by injectable. What a major development, a breakthrough in science.”

Cabotegravir, is a long-lasting integrase inhibitor. It’s a new generation of drug, unlike Gilead’s Truvada, currently used as PrEP, which has been around for several years.

Cabotegravir, also known as GSK 444, has not yet been approved by the U.S. Food and Drug Administration. It is being developed jointly by Glaxo Smith Kline and ViiV Healthcare.

Used as PrEP, the drug is in phase II clinical trials among men who have sex with men and transgender women in the Americas and Thailand. It already has been proven safe and effective against vaginal transmission of HIV in monkeys.

Results from the human trials are expected late this year and early next year.

Used as a long-lasting injectable treatment for HIV-infected people, Cabotegravir, along with another drug, Rilpivarine, is expected to enter phase III trials early next year.

The news is important because detractors of PrEP, largely Michael Weinstein of AIDS Healthcare Foundation, claim those who take it likely would not be adherent. An injectable version would guarantee long-lasting delivery in a healthcare setting.

Preliminary trials already have demonstrated safety and efficacy. The drug would be injected into the buttocks.

Used as PrEP, Cabotegravir may initially be rolled out in oral form to speed up approval.

Levin concluded his presentation last month declaring “substantial progress” in the development and proven efficacy of Cabotegravir as PrEP.