ArticleOpen forum infectious diseases2026
Once-Daily Dolutegravir-Based Antiretroviral Therapy Among Adults With Advanced HIV Disease Receiving 1 Month of Daily Rifapentine and Isoniazid for Tuberculosis-Preventive Therapy and Fluconazole for Treatment of Cryptococcal Meningitis: Results of a Pharmacokinetic Study.
Article in Open forum infectious diseases, 2026. 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
Background: One month of daily isoniazid and rifapentine (1HP) is an efficacious, well-tolerated, and safe tuberculosis-preventive therapy regimen. Its implementation has been slow due to concern about drug-drug interactions with rifapentine. Methods: This single-arm pharmacokinetic study included 15 adults with advanced human immunodeficiency virus (HIV) disease receiving once-daily 50-mg dolutegravir-based antiretroviral therapy during 1HP therapy, alongside once-daily 800-mg fluconazole for treatment of cryptococcal meningitis. Participants underwent intensive pharmacokinetic sampling on days 1, 5, and 14 of 1HP therapy; sampling was conducted before and 2, 4, 8, and 24 hours after dosing. Dolutegravir, rifapentine, and fluconazole plasma concentrations were measured by means of high-performance liquid chromatography mass spectrometry, and bioequivalence was assessed with standard 90% confidence intervals (CIs). Results: Fifteen participants were enrolled, of whom 9 (60%) were female. The median age (interquartile range) was 37 (27-41) years, and the median CD4 cell count was 11/μL (10-25/μL). Overall, 14 of 15 participants completed sampling on days 5 and 14. The day 14 geometric mean (GM) dolutegravir trough concentration (95% CI) was 0.61 (.32-1.16) mg/L, while the median (interquartile range) was 0.63 (0.34-0.87) mg/L, with 100% of samples above the dolutegravir protein-adjusted 90% inhibitory concentration of 0.064 mg/L, with a GM ratio of 0.76 (90% CI, .4-1.46) compared with day 1. The day 14 maximum plasma concentration and area under the concentration-time curve from 0 to 24 hours for fluconazole were reduced compared with day 1, with GM ratios of 0.73 (90% CI, .57-.94) and 0.77 (.64-.93), respectively. Of 14 participants alive at 12 weeks after 1HP initiation, 11 (78%) had an HIV viral load (VL) <200 copies/mL. No cases of cryptococcal meningitis relapse occurred during the 18-week follow-up. Conclusions: Standard once-daily 50-mg dolutegravir and 800-mg fluconazole dosing may be a safe and effective option for patients receiving 1HP tuberculosis-preventive therapy. These findings support further evaluation in larger studies.
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