Weight gain can be an unpleasant side effect of some antiretroviral therapy treatment regimens containing integrase inhibitors. With the rise in pre-exposure prophylaxis (PrEP) for HIV-uninfected individuals, there is a need to determine whether similar metabolic side effects exist.
Investigators of HPTN 077, a phase 2a randomized, placebo-controlled study of 2 dose/dose-interval regimens of oral and injectable cabotegravir in HIV-uninfected individuals, found no association between cabotegravir and weight gain in persons without HIV.
The findings of the study were presented today, March 5, 2019, as a late breaker in an oral abstract session at the Annual Conference on Retroviruses and Opportunistic Infections (CROI 2019).
A total of 199 HIV-negative male and female participants from 8 sites in the United States, Brazil, and sub-Saharan Africa were enrolled and randomized 3:1 to receive active cabotegravir or placebo. The participants received oral cabotegravir 30 mg or placebo once a day for 4 weeks, a 1-week washout, and then sequential injections of long-acting cabotegravir or 0.9% saline placebo from week 5 through week 41.
Baseline weight assessments were conducted, as well as assessments of body mass index (BMI), smoking status, age, and race/ethnicity. Weight was then measured during the oral product administration and injectable study administration.
Median weight change over 41 weeks was +1.1 kg (2.42 pounds) (IQR 0.9, 3.0) in the cabotegravir arm and +1.0 kg (IQR -1.2, 3.2) in the placebo arm (p = .66). Therefore, there was no difference in weight change for participants receiving cabotegravir or placebo.
“In longitudinal statistical analyses, no statistically significant differences were found in change in weight from [week] 0 to 41 in cabotegravir vs. placebo treated participants in aggregate, by sex, dosing cohort, age, race/ethnicity, smoking status, BMI, nor by baseline BMI category,” investigators concluded in the study abstract. “No differences in weight change for cabotegravir vs. placebo were seen for [week] 0-4 and [week] 5-41 separately.”
By Alexandra Ward
The study, “Cabotegravir Is Not Associated With Weight Gain in HIV-Negative Individuals: HPTN 077,” was presented on Tuesday, March 5, 2019, at CROI 2019 in Seattle, Washington.