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Comparative effectiveness of first-line antiretroviral therapy

results from a large real-world cohort after the implementation of dolutegravir

Meireles, Mariana Velosoa; Pascom, Ana Roberta P.a; Duarte, Elisabeth C.b; McFarland, Willic

doi: 10.1097/QAD.0000000000002254

Objective: We aimed to assess the effectiveness of first-line antiretroviral therapy (ART) regimens in achieving viral suppression at 12 months, from 2014 to 2017 in Brazil.

Design: A retrospective cohort study utilizing programmatic data from the Brazilian HIV Program.

Methods: Adults (aged 15–80 years) who started ART from January 2014 to July 2017 and had a viral load 365 (±90) days after treatment initiation were included. Associations with achieving viral suppression (<50 copies/ml) at 365 (±90) days were assessed using logistic regression. Our main study variable was ART regimen, and covariates included year of ART initiation, sex/exposure group, age, education, race, region, baseline CD4+ and viral load counts, and adherence measured by pharmacy refill data. We performed both intent-to-treat and per-protocol analogous analyses.

Results: Out of 107 647 ART-naive patients, 71.5% initiated with tenofovir/lamivudine/efavirenz (TLE) and 10.5% with tenofovir/lamivudine/dolutegravir (TLD). Median age and CD4+ cell counts were 34 [interquartile range (IQR) 26–46] and 379 cells/μl (IQR 190–568), respectively; 68.0% were men. Viral suppression by 12 months was 84.0% [95% confidence interval (95% CI) 83.7–84.2] with TLE and 90.5% (95% CI 90.0–91.0) with TLD, and below 80% for protease-inhibitor-based regimens. In the multivariable intent-to-treat-analogous analysis, controlling for cofactors related to viral suppression including adherence, the adjusted odds ratio (aOR) for TLD's viral suppression relative to TLE was 1.56 (95% CI 1.40–1.75). Findings were robust to secondary per-protocol analogous and sensitivity analysis.

Conclusion: Our results showed the superiority of dolutegravir- over efavirenz- and protease-inhibitor-based regimens in suppressing viral replication in a real-word cohort of HIV-positive adults. This superiority was not driven by higher levels of adherence with dolutegravir-based regimens.

aDepartment of STIs, HIV/AIDS and Viral Hepatitis, Ministry of Health of Brazil

bTropical Medicine Division, Faculty of Medicine, University of Brasilia, Brasilia, Brazil

cUniversity of California, San Francisco, California, USA.

Correspondence to Mariana Veloso Meireles, Department of STIs, HIV/AIDS and Viral Hepatitis, Ministry of Health of Brazil, SRTVN Quadra 701 Lote D, Asa Norte, 5° andar, 70719-040 Brasília, DF, Brazil. E-mail:

Received 4 February, 2019

Revised 4 April, 2019

Accepted 12 April, 2019

Copyright © 2019 Wolters Kluwer Health, Inc.