2025/04/11 by Rena C. Patel, Nkosiphile Ndlovu, Pooja Maheria +15 · 1 voice
Medicine · #Reproductive Health and Contraception #HIV/AIDS drug development and treatment #HIV/AIDS Research and Interventions
paper · doi:10.1093/infdis/jiaf196
openalex publication_date 2025/04/11 · openalex created_date 2025/04/23 · openalex updated_date 2026/07/25
BACKGROUND: Drug resistance and intolerance of dolutegravir-containing antiretroviral therapy (ART) are rising in low- and middle-income countries, resulting in a potentially increased use of doravirine-containing ART use. There are knowledge gaps regarding doravirine and hormonal contraceptive drug-drug interactions among women living with human immunodeficiency virus (HIV). METHODS: We conducted a 5-parallel-group, prospective pharmacokinetic study among women living with HIV aged 18-45 years in Johannesburg, South Africa, between November 2021 and February 2024. We included a sixth, historical comparator group from a Kenyan study. After a ≥6-week lead-in period with doravirine-containing ART, participants initiated injectable medroxyprogesterone acetate (MPA), implantable etonogestrel (ENG), or nonhormonal intrauterine device contraception and were observed every 2-4 weeks for an additional 12 or 24 weeks. We analyzed serum MPA and ENG and plasma doravirine or dolutegravir concentrations per visit, using validated liquid chromatography-mass spectrometry assays. We assessed log-transformed concentrations of each drug with geometric mean ratios (90% confidence intervals) and a multivariate model adjusted for age and body mass index. We described safety, tolerability, and effectiveness (HIV RNA <40 copies/mL) of doravirine-containing ART. RESULTS: A total of 128 participants are included in this analysis. There were no significant reductions in the MPA, ENG, or doravirine concentrations. A total of 8 (3%) adverse events grade ≥2 were considered attributable to doravirine-containing ART and 22 (8%) to the contraceptive method. ART satisfaction was 100%, and viral suppression at study exit ranged from 86% to 96%. CONCLUSIONS: We found no detrimental bidirectional drug-drug interactions and few adverse events between doravirine and hormonal contraceptives.