HIV Drug Scores Home Run in Phase III Study for Women

While any new research on the human immunodeficiency virus (HIV) is welcome, the majority has been focused on men. Researchers have found that the sexes feel pain differently, so the fact that gender-specific studies have been lacking for women only inhibits progress. However, the first trial of its kind used all women to assess the efficacy of an HIV medication.

While any new research on the human immunodeficiency virus (HIV) is welcome, the majority has been focused on men. Researchers have found that the sexes feel pain differently, so the fact that gender-specific studies have been lacking for women only inhibits progress. However, the first trial of its kind used all women to assess the efficacy of an HIV medication.

The Women’s Antiretroviral Efficacy and Safety Study (WAVES) analyzed the drug Stribild (consisting of cobicistat, elvitegravir, emtricitabine, and tenofovir). It’s the first randomized, double-blind antiretroviral study to exclusively enroll women and successfully showed improved safety and efficacy when compared to multi-drug strategies in phase III. The findings were presented at the American Society for Microbiology’s 55th Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC/ICC) in San Diego, CA.

“The optimal selection of HIV treatment should be evidence-based and WAVES provides clinical safety and efficacy data to assist women and their clinicians in the informed selection of antiretroviral treatment regimens,” author Sally Hodder, MD, director of the West Virginia Clinical and Translational Science Institute, said in a news release.

The trial included 575 women with HIV-1 with an average age of 35. Further demographics detailed that participants were from North America, Latin America, Europe, Asia, and Africa and 48% were African American. They were randomly assigned to either receive Stribild or ritonavir-boosted atazanavir plus Truvada. The data revealed that the women in the Stribild group had a statistically higher rate of HIV suppression.

Notably, those in the multi-drug group were more likely to develop rash, jaundice, and liver-related adverse effects that caused participants to stop the regimen. Also, three women in that group developed a resistant mutation to HIV-1 — an adverse reaction that wasn’t observed in the Stribild group.

So if half of HIV diagnoses worldwide are accounted for women, and the infection rate continues to rise, why are more studies conducted solely using men? Perhaps more importantly, why is that data generalized to both men and women? That may be a bigger hurdle to tackle in the future, but Hodder took a step in the right direction with this trial.