ArticleThe Journal of infectious diseases2025
Pharmacokinetic and Clinical Associations Between Doravirine-Containing Antiretroviral Therapy and Injectable and Implantable Hormonal Contraceptive Methods Among Women Living With Human Immunodeficiency Virus in South Africa.
Article in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundDrug 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).
methodsWe 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.
resultsA 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%.
conclusionsWe found no detrimental bidirectional drug-drug interactions and few adverse events between doravirine and hormonal contraceptives.
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