A Call for Gender Equity in HIV Prevention Drug Approvals

The U.S. Food and Drug Administration's decision to approve Descovy for PrEP with an exclusion for cisgender women was cause for concern among IDSA and HIVMA members. We shared our concerns regarding the impact of that decision on patient care in a letter to Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research.The societies urged the FDA to apply the following principles in evaluating future HIV prevention drug approvals: 

• require clinical trial data for both genders;
• enforce the 1993 FDA guidance on the evaluation of gender differences; and
• set a high standard and strong clinical justification for approving a drug for one gender and not the other.

The CDC estimated in 2017 that adult and adolescent women represented 19% of new HIV diagnoses, and 85% of new diagnoses in women were in women of color. Descovy is the second drug approved for PrEP, and study data showed it to be noninferior to Truvada for PrEP in men and transgender women who have sex with men. Gilead Sciences, the manufacturer of Descovy, has committed to conducting a post-marketing study to evaluate Descovy for PrEP in cisgender women and adolescents girls.