WASHINGTON (Reuters) – Gilead Sciences Inc’s Truvada may prevent HIV infection among high-risk individuals, if used in combination with other health strategies, and is well-tolerated by individuals who have not contracted HIV, U.S. Food and Drug Administration review documents said on Tuesday.
Truvada is a combination of Gilead’s HIV drugs Emtriva, also known as emtricitabine, and Viread, or tenofovir.
An outside panel of experts is scheduled to examine the FDA review documents on Thursday and make recommendations that U.S. health regulators will consider in deciding whether the drug should be used as a preventive treatment.
The drug is already approved to treat people with HIV infection.
Some experts warn that Truvada is only partially effective against HIV and that using it to prevent infection could cause protection from the virus to falter if patients fail to adhere to treatment.
FDA staff said they could not predict the frequency of drug resistance among Truvada users but suggested the danger might be minimized by limiting the duration of drug exposure after infection occurs.
The review documents said the decision to prescribe Truvada as a preventive treatment should be weighed carefully against an individual’s risk for infection, understanding of the importance of adhering to medication and potential for renal toxicity.