Produção Nacional
Revisado por pares
Dolutegravir-based Antiretroviral Therapy for Patients Coinfected With Tuberculosis and Human Immunodeficiency Virus: A Multicenter, Noncomparative, Open-label, Randomized Trial
2019; Oxford University Press; Volume: 70; Issue: 4 Linguagem: Inglês
10.1093/cid/ciz256
ISSN1537-6591
AutoresKelly E. Dooley, Richard Kaplan, Noluthando Mwelase, Beatriz Grinsztejn, Eduardo Ticona, Marcus Lacerda, Omar Sued, Elena Belonosova, Mounir Ait‐Khaled, Konstantinos Angelis, Dannae Brown, Rajendra Singh, Christine L. Talarico, Allan R. Tenorio, Michael R. Keegan, Michael Aboud, Kelly E. Dooley, Kaplan Richard, Mwelase Noluthando, Beatriz Grinsztejn, Ticona Chavez Eduardo, Lacerda Marcus, Omar Sued, Elena Belonosova, Ait-Khaled Mounir, A. Konstantinos, Brown Dannae, Singh Rajendra, Christine L. Talarico, Allan R. Tenorio, Michael R. Keegan, Michael Aboud, Lupo Sergio, Pedro Cahn, Norma Porteiro, Daniel Lopardo Gustavo, Riegel Santos Breno, Madruga Jose, Roberto Alves Carlos, Patricia Quintero Perez Nora, Rodriguez Noriega Eduardo, P. Alma, Perez Patrigeon Santiago, Mosqueda-Gómez Juan-Luis, Paredes Paredes Mercedes, R Boccaccini Aldo, Mac Rae John, Casapia Wilfredo, Sanchez Vergaray Eduardo, Elena Belonosova, Sultanov Lenar, Ivanova Elvira, Yakovlev Alexey, Panteleev Alexander, Dawson Rodney, Latiff H Gulam, Mohapi Lerato, Taljaard Jantjie, Jurgens Lombaard Johannes, Khan Mohammed, Ebrahim Variava, Chetchotisakd Ploenchan, Kiertiburanakul Sasisopin, Anchalee Avihingsanon,
Tópico(s)Pneumocystis jirovecii pneumonia detection and treatment
ResumoAbstract Background The concurrent treatment of tuberculosis and human immunodeficiency virus (HIV) is challenging, owing to drug interactions, overlapping toxicities, and immune reconstitution inflammatory syndrome (IRIS). The efficacy and safety of dolutegravir (DTG) were assessed in adults with HIV and drug-susceptible tuberculosis. Methods International Study of Patients with HIV on Rifampicin ING is a noncomparative, active-control, randomized, open-label study in HIV-1–infected antiretroviral therapy–naive adults (CD4+ ≥50 cells/mm3). Participants on rifampicin-based tuberculosis treatment ≤8 weeks were randomized (3:2) to receive DTG (50 mg twice daily both during and 2 weeks after tuberculosis therapy, then 50 mg once daily) or efavirenz (EFV; 600 mg daily) with 2 nucleoside reverse transcriptase inhibitors for 52 weeks. The primary endpoint was the proportion of DTG-arm participants with plasma HIV-1-RNA <50 copies/mL (responders) by the Food and Drug Administration Snapshot algorithm (intent-to-treat exposed population) at Week 48. The study was not powered to compare arms. Results For DTG (n = 69), the baseline HIV-1 RNA was >100 000 copies/mL in 64% of participants, with a median CD4+ count of 208 cells/mm3; for EFV (n = 44), 55% of participants had HIV-1 RNA >100 000 copies/mL, with a median CD4+ count of 202 cells/mm3. The Week 48 response rates were 75% (52/69, 95% confidence interval [CI] 65–86%) for DTG and 82% (36/44, 95% CI 70–93%) for EFV. The DTG nonresponses were driven by non–treatment related discontinuations (n = 10 lost to follow-up). There were no deaths or study drug switches. There were 2 discontinuations for toxicity (EFV). There were 3 protocol-defined virological failures (2 DTG, no acquired resistance; 1 EFV, emergent resistance to nucleoside reverse transcriptase inhibitors and nonnucleoside reverse transcriptase inhibitors). The tuberculosis treatment success rate was high. Tuberculosis-associated IRIS was uncommon (4/arm), with no discontinuations for IRIS. Conclusions Among adults with HIV receiving rifampicin-based tuberculosis treatment, twice-daily DTG was effective and well tolerated. Clinical Trials Registration NCT02178592.
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