HIV Drugs: What's in the Pipeline?

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The HCPLive Peer Exchange: Optimizing Outcomes in HIV Treatment features insight and opinion on the latest developments in HIV research, diagnosis, and management from leading physician specialists.

This Peer Exchange is moderated by Paul Doghramji, MD, who is a family physician at Collegeville Family Practice in Collegeville, PA, and Medical Director of health services at Ursinus College, also in Collegeville, PA.

The panelists are:

• Alfred A. DeLuca, MD, Infectious Disease Specialist at CentraState Healthcare System in Manalapan, NJ
• Ian Frank, MD, Director of Anti-Retroviral Clinical Research and Director of Clinical Core at Penn Center for AIDS Research, and Professor of Medicine at the Hospital of the University of Pennsylvania in Philadelphia, PA
• Paul Sax, MD, Associate Professor of Medicine at Harvard Medical School and Clinical Director of the Division of Infectious Diseases and the HIV Program at Brigham and Women's Hospital, in Boston, MA

This segment of the Peer Exchange focuses on novel HIV treatments that are currently in the pipeline, including new formulations of existing products and fixed-dose combination agents.

There is a new investigational adaptation of tenofovir, called tenofoviralafenamide (TAF). Its drug concentrations are very high intracellularly but very low in the blood, which is good for antiviral activity, says Sax. In a blinded phase 2 study of treatment-naïve patients, participants were randomized 2:1 to receive either tenofovir or TAF, and they were also given the other components of Stribild. “I was actually pleasantly surprised by the results,” says Sax, which included similar virologic suppression rates but a renal profile and bone mineral density levels that were statistically significantly better with TAF than with tenofovir. Phase 3 trials have been completed, and initial results have been reported in a press release, confirming the same results.

One of the advantages of the new formulation of tenofovir, according to Frank, is the “ability to package it together with protease inhibitors and cobicistat,” which is less complicated than the boosted protease inhibitors, which require taking three different pills.

There is also a fixed-dose combination product including darunavir, cobicistat, emtricitabine, and TAF, that is currently under investigation in a phase 3 trial, says Frank. According to Sax, “there is some suggestive, although it is associative, evidence that [fixed-dose combination agents] are actually better for patients,” in terms of hospitalization rates, virologic failures, and medication errors, and hopefully they will also be cost-effective.