2025/03/12 by Daniela Malano-Barletta, Anna Castelli, Mercè Brunet +43 · 1 voice · 1 citation
Medicine · #HIV-related health complications and treatments #HIV/AIDS drug development and treatment #Renal Transplantation Outcomes and Treatments
paper · pdf · doi:10.1093/ofid/ofaf119
openalex publication_date 2025/03/12 · openalex created_date 2025/10/10 · openalex updated_date 2026/07/30
Abstract Background This study assessed the pharmacokinetic interactions between dolutegravir (DTG)-based antiretroviral therapy (ART) and immunosuppressants in solid organ transplantation (SOT) recipients with HIV and ART safety. Methods A phase IV, single-center, open-label, single-arm clinical trial (DTG-SOT, NCT03360682) including adult SOT recipients with HIV conducted between 2017 and 2019. People with HIV with plasma viral load <50 copies/mL during ≥12 months and receiving stable raltegravir-based ART during ≥6 months were switched to tenofovir disoproxil fumarate/emtricitabine or lamivudine/abacavir + DTG and followed up for 48 weeks. Immunosuppressant pharmacokinetic parameters were compared before and 2 weeks after ART switch (primary outcome). Efficacy and safety were analyzed at 48 weeks by intention-to-treat analysis. Results Nineteen consecutive participants (median, 57 years; interquartile range, 51–60), mostly liver recipients (63.2%), received DTG/lamivudine/abacavir (63.2%) and DTG + emtricitabine/tenofovir disoproxil fumarate (36.8%). Pharmacokinetic parameters changed, albeit not significantly, before and after ART, for mycophenolic acid (maximum [Cmax] +63%, trough [Cmin] +53%, area under the curve [AUC] +16%; n = 7) and cyclosporine A (Cmax −64%, Cmin +14%, AUC −47%; n = 2), with smaller changes for tacrolimus (Cmax +14%, Cmin −29%, AUC −9%; n = 7). No participants experienced acute rejection or virological failure and CD4+ cell counts and percentages remained unchanged during follow-up. Three (15.8%) discontinued treatment because of adverse events. Estimated glomerular filtration rate decreased (P = 0.0015) and creatinine increased (P = 0.0001) slightly. Conclusions DTG-based ART lacked clinically significant drug–drug interactions with tacrolimus and mycophenolic acid. Switching to DTG-based ART was effective in people with HIV SOT recipients. More studies are needed to evaluate DTG safety in this setting.