SAN DIEGO — A once-daily antiretroviral regimen consisting of Stribild (Gilead) had a better rate of HIV suppression than a multi-pill regimen, according to results from the first phase 3 HIV study to enroll only women and sponsored by Gilead Sciences.
The research was presented at ASM’s 55th Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC/ICC).
Although regulatory guidelines specify that gender‐based assessment of drug efficacy, toxicity and tolerability profiles should be incorporated into clinical trials, women are routinely underrepresented in HIV clinical trials, so the Women’s Antiretroviral Efficacy and Safety Study (WAVES) looked at this population specifically, according to the study researchers.
Women receiving the drug Stribild had a statistically higher rate of HIV suppression compared with the group that received ritonavir-boosted atazanavir plus Truvada, according to study researcher Sally Hoder, MD. Additionally, no one receiving Stribild developed resistant mutation to HIV-1, compared to three 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,” Hodder, who is Director of the West Virginia Clinical and Translational Science Institute explained. Dr. Hodder discussed the findings during a media event.
The trial enrolled 575 HIV-1 infected women from Africa, Asia, Europe, Latin America and North America. The median age of study participants was 35 years old, 48% were black and the majority reported unprotected heterosexual intercourse as the mode of HIV-1 acquisition.
The highest virological response to both regimens was observed in Uganda and the lowest rate of response was reported in the U.S. due to lower study drug adherence and a higher rate of discontinuation attributed to lost to follow up, the researchers said. Women in Russia achieved a statistically higher response rate to Stribild due to adverse events, which prompted early discontinuation in the ritonavir-boosted atazanavir plus Truvada arm.
Women receiving ritonavir-boosted atazanavir plus Truvada were at increased risk for rash, jaundice and liver-related adverse reactions that led to study drug discontinuation, researchers noted.
1. Hodder S. Slide Session: Elvitegravir (EVG)/Cobicistat(COBI)/Emtricitabine(FTC)/Tenofovir Disoproxil Fumarate(TDF) is Superior to Ritonavir (RTV) Boosted Atazanavir (ATV) Plus FTC/TDF in Treatment Naïve Women with HIV-1 Infection (WAVES Study). Presented at: ICAAC/ICC 2015; Sept. 17-21, 2015; San Diego.