First All-Women HIV Study Yields Positive Results for Stribild

Current HIV treatment guidelines are based on data obtained primarily from men.

Results from the first phase 3 all-women HIV study (WAVES) showed improvements in both safety and efficacy for the drug Stribild over multi-pill antiretroviral therapies.

The study showed that women treated with Stribild experienced higher rates of HIV suppression compared with the group that received ritonavir-boosted atazanavir plus Truvada. No one receiving Stribild developed resistant mutation to HIV-1, compared with 3 women in the comparator group.

“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,” said study author Sally Hodder, MD, director of the West Virginia Clinical and Translational Science Institute.

The trial enrolled 575 HIV-1 infected women from around the world, including Africa, Asia, Europe, Latin America, and North America. The median age of participants was 35 years of age, and 48% of participants were black. The majority of those involved in the study reported unprotected heterosexual sex as the source of their HIV-1 infection.

Findings from the study showed higher virological responses to both regimens in Uganda, while lower rates of response were reported in the United States due to lower drug adherence and a higher rate of discontinuation. Women who received treatment with atazanavir and Truvada were at higher risk of jaundice, rash, and liver-related adverse reactions that led to study drug discontinuation.

“Women account for half of the global HIV epidemic and the number of new infections continues to rise,” Dr. Hodder said.

While regulatory guidelines specify that gender-based assessment of drug efficacy, toxicity, and tolerability should be a part of clinical trials, women are still severely underrepresented in HIV clinical trials.

“As a consequence, current HIV treatment guidelines are based on data obtained primarily from men, but subsequently generalized and applied to both men and women,” Dr. Hodder said.

This may produce gender bias and inaccuracies in the standard of evidence-based medicine.

With further testing and clinical trials targeted towards women, researchers can surely find new evidence to support the use of Stribild in treating women with HIV-1 infection. Additional research may even yield new evidence regarding women’s issues with the disease, providing new treatment options and therapies to women who are HIV infected.