A Trial of a Single-tablet Regimen of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate for the Initial Treatment of Human Immunodeficiency Virus Type 2 Infection in a Resource-limited Setting: 48-Week Results From Senegal, West Africa
Selly Ba, Dana N Raugi, Robert A Smith, Fatima Sall, Khadim Faye, Stephen E Hawes, Papa Salif Sow, Moussa Seydi, Geoffrey S Gottlieb, University of Washington–Dakar HIV-2 Study Group, Fatou Traore, Marie Pierre Sy, Bintou Diaw, Mbaye Ndoye, Amadou Bale Diop, Marianne Fadam Diome, Alassane Niang, Jean Jacques Malomar, ElHadji Ibrahima Sall, Ousseynou Cisse, Ibrahima Tito Tamba, Jean Philippe Diatta, Jacques Sambou, Raphael Bakhoum, Juliette Gomis, Noelle Benzekri, John Lin, Nancy Kiviat, Sally Leong, Sara Masoum, Vincent Wu, Carol Gallardo, Eleanor Espinosa, Ming Chang, Bob Coombs, Selly Ba, Dana N Raugi, Robert A Smith, Fatima Sall, Khadim Faye, Stephen E Hawes, Papa Salif Sow, Moussa Seydi, Geoffrey S Gottlieb, University of Washington–Dakar HIV-2 Study Group, Fatou Traore, Marie Pierre Sy, Bintou Diaw, Mbaye Ndoye, Amadou Bale Diop, Marianne Fadam Diome, Alassane Niang, Jean Jacques Malomar, ElHadji Ibrahima Sall, Ousseynou Cisse, Ibrahima Tito Tamba, Jean Philippe Diatta, Jacques Sambou, Raphael Bakhoum, Juliette Gomis, Noelle Benzekri, John Lin, Nancy Kiviat, Sally Leong, Sara Masoum, Vincent Wu, Carol Gallardo, Eleanor Espinosa, Ming Chang, Bob Coombs
Abstract
Background: There is an urgent need for safe and effective antiretroviral therapy (ART) for human immunodeficiency virus type 2 (HIV-2) infection. We undertook the first clinical trial of a single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) to assess its effectiveness in HIV-2-infected individuals in Senegal, West Africa.
Methods: HIV-2-infected, ART-naive adults with World Health Organization stage 3-4 disease or CD4 count <750 cells/μL were eligible for this 48-week, open-label trial. We analyzed HIV-2 viral loads (VL), CD4 counts, clinical and adverse events, mortality, and loss to follow-up.
Results: We enrolled 30 subjects who initiated E/C/F/TDF. Twenty-nine subjects completed 48 weeks of follow-up. The majority were female (80%). There were no deaths, no new AIDS-associated clinical events, and 1 loss to follow-up. The median baseline CD4 count was 408 (range, 34-747) cells/μL, which increased by a median 161 (range, 27-547) cells/μL at week 48. Twenty-five subjects had baseline HIV-2 VL of <50 copies/mL of plasma. In those with detectable HIV-2 VL, the median was 41 (range, 10-6135) copies/mL. Using a modified intent-to-treat analysis (US Food and Drug Administration Snapshot method), 28 of 30 (93.3%; 95% confidence interval, 77.9%-99.2%) had viral suppression at 48 weeks. The 1 subject with virologic failure had multidrug-resistant HIV-2 (reverse transcriptase mutation: K65R; integrase mutations: G140S and Q148R) detected at week 48. There were 8 grade 3-4 adverse events; none were deemed study related. Adherence and acceptability were good.
Conclusions: Our data suggest that E/C/F/TDF, a once-daily, single-tablet-regimen, is safe, effective, and well tolerated. Our findings support the use of integrase inhibitor-based regimens for HIV-2 treatment.
Clinical trials registration: NCT02180438.
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Source: PubMed