The U.S. Food and Drug Administration's advisory panel in Washington is scheduled to discuss Thursday the efficacy supplement for Truvada (emtricitabine/tenofovir disoproxil fumarate), submitted by Gilead Sciences Inc.
The supplemental application proposes an indication for Pre-Exposure Prophylaxis to reduce the risk of sexually acquired HIV-1 infection to high-risk individuals, such as the partners of those who have HIV/AIDS, along with safe sex precautions.
Experts warn Truvada only works if taken every day, but Truvada might spare patients "infection with a serious and life-threatening illness that requires lifelong treatment," the FDA reviewers concluded, Medicaldaily.com reported.
Truvada is already approved for those infected with HIV. However, there are some concerns for kidneys.
The FDA review said the results might not be helpful for women, because they only were represented in a small portion of the study.