New HIV drug could cure disease with just one pill [editor's title, not mine]

[The title was written by my editor. It is horribly inaccurate.]

Gilead Sciences has yet another blockbuster drug in the regulatory pipeline; this one is for offering lower dose treatment for HIV.

by John Tyburski

Copyright © Daily Digest News, KPR Media, LLC. All rights reserved.

First published at Daily Digest News on November 6, 2014

The Foster City, California, drug maker Gilead Sciences announced Thursday that it is seeking review by the U.S. Food and Drug Administration for its new daily HIV drug that will offer the same therapeutic benefit as existing drugs but at lower doses and with fewer side effects. The new drug, TAF, is a different formulation of the active ingredient in the existing drug Viread.

Gilead has made headlines in recent months for other promising yet expensive drugs. In May, the U.S. Centers for Disease Control and Prevention endorsed Gilead’s Truvada, which costs around $15,000 per patient per year, for use as a HIV pre-exposure prophylaxis in individuals at high risk for contracting HIV. Despite concerns that Truvada would encourage risky behaviors, at least one study suggests it does not.

Gilead Sciences also manufactures and markets the hepatitis C drug Sovaldi, which costs $1,000 per patient per day and is given daily for 12 weeks. While the drug is highly effective, treating one case of hep C with Sovaldi costs $84,000, a price tag a bit too rich for some states to cover in their Medicaid programs.

Gilead generates most of its revenue through a strong collection of HIV drugs. Stribild is given to adults who are beginning treatment for HIV. Stribild is a combination of some of Gilead’s other drugs: Vitekta, Tybost, Emtriva, and Viread. Adding TAF in place of Viread in a Stribild treatment regimen offered the same performance but with a lower risk of kidney injury. The effective dose of TAF is also 10 times lower than that of Viread.

If TAF is approved, it means that HIV patients can take Stribild for longer periods because the onset of side effects will be delayed. This translates to more revenue for Gilead as it sells more of its drug.

“Gilead remains focused on advancing next-generation therapies that have the potential to improve HIV treatment over the long term, and TAF will be the cornerstone of future Gilead single-tablet regimens,” said Norbert Bischofberger, Gilead’s executive vice president of research and development and chief scientific officer in a statement.

Gilead Sciences is also planning to apply for TAF approval with the European Union by the end of the year.