Descovy Approved As Second HIV Prevention Drug Despite Ongoing Controversies

Federal drug regulators have approved the drug Descovy as a treatment to prevent the spread of HIV, providing an alternative to Truvada, which has been the only HIV PrEP drug available on the market, and has been linked to concerns about potential side effects associated with long-term use.

In a press release issued this week, the FDA announced that Descovy has been approved as an HIV-1 pre-exposure prophylaxis (PrEP), which can be used by individuals at risk of contracting HIV infections from most forms of sex.

However, the FDA cautions that Descovy has not been approved to help prevent HIV in those who receive receptive vaginal sex, indicating the drug’s effectiveness has not been tested in that situation.

“PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection,” Dr. Jeffrey Murray, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.”

Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) was developed by Gilead, which also manufactures Truvada and other widely used HIV drugs that are part of an older class of antivirals known as tenofovir disoproxil fumarate (TDF).

Side effects of TDF HIV drugs have been linked to an increased risk of bone fractures, kidney injury and other side effects. However, in recent years, the drug maker has introduced Descovy and other medications that are part of a newer class of antivirals known as tenofovir alafenamide (TAF), which are generally safer and less toxic.

This expanded approval of Descovy, which allows Gilead to promote the newer drug for HIV PrEP, comes as the drug maker was facing an approaching end of patent protection for Truvada, which will allow generic competitors to market the older treatment.

Over the past few years, Gilead has faced a number of Truvada lawsuits, alleging that the manufacturer intentionally withheld the safer TAF drugs for years, extending the period of patent protection that will allow the drug maker to market their HIV drugs without generic competition.

Plaintiffs allege that they suffered bone fractures, serious kidney problems and other injuries from Truvada, Atripla, Stribild and other TDF drugs, indicating that they may have avoided these injuries if Gilead had not intentionally delayed the development and approval of safer TAF-based drugs.

According to allegations raised in the lawsuits, Gilead knew that TAF was a safer alternative design, which allows delivery of the active ingredient at much lower doses. Although TAF development first started around 2004, the drug maker did not take steps to bring the safer design to market until 2015, as Truvada and other TDF drugs were nearing the end of patent protection.