Details

Autor(en) / Beteiligte

• Pacheco, Patrícia
• Marques, Nuno
• Rodrigues, Paulo
• Mansinho, Kamal
• Maltez, Fernando
• Janeiro, Nuno
• Franco, Cláudia
• Trigo, Diva
• Batista, Joana
• Duque, Luís
• Lopes, Maria João
• Aleixo, Maria João
• Silva, Ana Rita
• Tavares, Raquel
• Alves, João
• Peres, Susana
• Póvoas, Diana
• Lino, Sara
• Gomes, Perpétua
• Araújo, Vânia
• Lopes, Cristina

Titel

Safety and Efficacy of Triple Therapy With Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors in Treatment-Naive Human Immunodeficiency Virus Type 2 Patients: Results From a 48-Week Phase 2 Study

Ist Teil von

• Clinical infectious diseases, 2023-09, Vol.77 (5), p.740-748

Ort / Verlag

US: Oxford University Press

Erscheinungsjahr

2023

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• Abstract Background Integrase strand transfer inhibitor–based regimens are recommended for first-line therapy in human immunodeficiency virus type 2 (HIV-2). Nonetheless, dolutegravir (DTG) clinical trial data are lacking. Methods We conducted a phase 2, single-arm, open-label trial to evaluate the safety and efficacy of a triple therapy regimen that included DTG in persons with HIV-2 (PWHIV-2) in Portugal. Treatment-naive adults receive DTG in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs). Treatment efficacy was evaluated by the proportion of patients who achieved a plasma viral load (pVL) <40 copies/mL and/or by the change from baseline in CD4+ T-cell count and in CD4/CD8 ratio at week 48. Results A total of 30 patients were enrolled (22 women; median age, 55 years). At baseline, 17 (56.7%) individuals were viremic (median, pVL 190 copies/mL; interquartile range [IQR], 99–445). The median CD4 count was 438 cells/μL (IQR, 335–605), and the CD4/CD8 ratio was 0.8. Three patients discontinued the study. At week 48, all participants (27) had pVL <40 copies/mL. No virological failures were observed. Mean changes in CD4 count and CD4/CD8 ratio at week 48 were 95.59 cells/µL (95% confidence interval [CI], 28–163) and 0.32 (95% CI, .19 to .46). The most common drug-related adverse events were headache and nausea. One participant discontinued due to central nervous system symptoms. No serious adverse events were reported. Conclusions DTG plus 2 NRTIs is safe and effective as first-line treatment for PWHIV-2 with a tolerability profile previously known. No virological failures were observed that suggest a high potency of DTG in HIV-2 as occurs in HIV-1. Clinical Trials Registration M NCT 03224338. Graphical Abstract Graphical Abstract This graphical abstract is also available at Tidbit: https://tidbitapp.io/tidbits/safety-and-efficacy-of-triple-therapy-with-dolutegravir-plus-two-nrtis-in-treatment-naive-hiv-2-patients-results-from-a-48-week-phase-ii-study-2b6c6a90-7bd0-48a1-a715-f02551e24d18 This was an open-label, single-arm, multicenter, phase 2 clinical study conducted in Portugal. We present 48-week results regarding safety and efficacy of triple therapy with dolutegravir plus 2 nucleoside reverse transcriptase inhibitors in treatment-naive PWHIV-2.