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The authors performed a secondary analysis of cisgender women who were enrolled in HPTN 077, a Phase 2a multicenter study that enrolled HIV- uninfected, low risk individuals in Malawi, Brazil, South Africa, and the US. Participants received a 4 week oral CAB lead-in, followed by CAB LA 800mg Q12w IM (Cohort 1) or 600mg q8w IM (after a 4 week initial interval between injections, Cohort 2) over 41 weeks. Participants were followed 52-76 weeks subsequent to their final injection. Linear regression was used to evaluate differences in pharmacokinetic (PK) parameters (peak concentration [Cmax], trough [Cτ], exposure after the last injection [AUC0-τ], and apparent terminal half-life after the last injection [T1/2app]) between hormonal contraception (use vs not) and contraception type (oral, injectable, vaginal ring, implants, other) controlling for body mass index (BMI) and CAB dose cohort.
85 cisgender females enrolled in HPTN 077 and received at least 1 dose of active CAB LA. In this study population, BMI associated with 1% reduction (per unit increase in BMI) in Cmax, Cτ, and AUC0-τ and 2% increase in T1/2app. Median BMI was 27.2 in Cohort 1 and 25.7 in Cohort 2. Use of any type of hormonal contraceptive, individually or in aggregate, did not result in statistically significant changes in Cmax, Cτ, AUC0-τ, or T1/2app (Table, all p >0.05, Cmax, AUC0-τ not shown). No pregnancies occurred among those receiving active CAB LA during the study period. The impact of CAB on estrogen concentrations were not assessed
The authors concluded that among HIV-uninfected females in HPTN 077, use of hormonal contraception did not alter the CAB concentration profile during injections or during the pharmacokinetic tail. While there is no anticipation of an effect of CAB on estrogen concentration, the effects of CAB LA on hormonal treatment for both contraception and gender-affirming treatment warrant evaluation.
Cottle, L, Richarson, P, Marzinke, M, Eshleman, S, etc, Li, S, Chau, G. Hormonal contraceptives do not alter cabotegravir pk in hiv- uninfected women hptn 07. Conference On Retroviruses And Opportunistic Infections. 2019; : .