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April 13, 2018Clinical Infectious DiseasesOpen Access

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

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Authors

SBSelly BaCentre Hospitalier National Universitaire de Fann DRDana N. RaugiUniversity of Washington RSRobert A. SmithUniversity of Washington

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Implication

Open-label clinical trial demonstrates high viral suppression with single-tablet elvitegravir therapy in adults with HIV-2, supporting integrase inhibitors for frontline care.

Key Points

To evaluate the safety, tolerability, and effectiveness of a once-daily single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for treating HIV-2 infection.
Conducted a 48-week, open-label interventional clinical trial (NCT02180438) in Senegal in ART-naive adults with HIV-2 infection and WHO stage 3–4 disease or CD4 count <750 cells/μL (N=30).
Administered once-daily elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) and monitored plasma HIV-2 viral load, CD4 counts, safety events, and loss to follow-up over 48 weeks.
Viral suppression at 48 weeks occurred in 28 of 30 participants (93.3%; 95% CI, 77.9%–99.2%) via modified intent-to-treat FDA Snapshot analysis.
CD4 cell counts increased by a median of 161 cells/μL (range, 27–547) from a baseline median of 408 cells/μL, with no deaths or AIDS-defining clinical events reported.
Eight grade 3–4 adverse events occurred with none deemed treatment-related, and the single participant with virologic failure developed multidrug-resistant mutations (K65R, G140S, Q148R).

Cite This Study

Ba et al. (2018) studied this question.

synapsesocial.com/papers/6a9bd229d8d8bde79ebb0c8d https://doi.org/10.1093/cid/ciy324

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Implication

Open-label clinical trial demonstrates high viral suppression with single-tablet elvitegravir therapy in adults with HIV-2, supporting integrase inhibitors for frontline care.

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

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Implication

Key Points

Cite This Study

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

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Implication

Key Points

Cite This Study

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