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. 2015 Jun 24;10(6):e0128131.
doi: 10.1371/journal.pone.0128131. eCollection 2015.

Effectiveness of a Treatment Switch to Nevirapine plus Tenofovir and Emtricitabine (or Lamivudine) in Adults with HIV-1 Suppressed Viremia

Josep M Llibre  1 , Isabel Bravo  2 , Arelly Ornelas  3 , José R Santos  1 , Jordi Puig  2 , Raquel Martin-Iguacel  4 , Roger Paredes  5 , Bonaventura Clotet  5
Affiliations

Effectiveness of a Treatment Switch to Nevirapine plus Tenofovir and Emtricitabine (or Lamivudine) in Adults with HIV-1 Suppressed Viremia

Josep M Llibre et al. PLoS One. .

Abstract

Background: Switching subjects with persistently undetectable HIV-1 viremia under antiretroviral treatment (ART) to once-daily tenofovir/emtricitabine (or lamivudine) + nevirapine is a cost-effective and well-tolerated strategy. However, the effectiveness of this approach has not been established.

Methods: We performed a retrospective study evaluating the rates of treatment failure, virological failure (VF), and variables associated, in all subjects initiating this switch combination in our clinic since 2001. Analyses were performed by a modified intention to treat, where switch due to toxicity equalled failure. The main endpoint was plasma HIV-RNA < 50 copies/mL.

Results: 341 patients were treated for a median of 176 (57; 308) weeks. At week 48, 306 (89.7%) subjects had HIV-1 RNA <50 copies/mL, 10 (2.9%) experienced VF, and 25 (7.4%) discontinued the treatment due to toxicity. During the whole follow-up 23 (6.7%) individuals (17 on lamivudine, 6 on emtricitabine; p = 0.034) developed VF and treatment modification due to toxicity occurred in 36 (10.7%). Factors independently associated with VF in a multivariate analysis were: intravenous drug use (HR 1.51; 95%CI 1.12, 2.04), time with undetectable viral load before the switch (HR 0.98; 0.97, 0.99), number of prior NRTIs (HR 1.49; 1.15, 1.93) or NNRTIs (HR 3.22; 1.64, 6.25), and previous NVP (HR 1.54; 1.10, 2.17) or efavirenz (HR 5.76; 1.11, 29.87) unscheduled interruptions. VF was associated with emergence of usual nevirapine mutations (Y181C/I/D, K103N and V106A/I), M184V (n = 16; 12 with lamivudine vs. 4 with emtricitabine, p = 0.04), and K65R (n = 7).

Conclusions: The rates of treatment failure at 48 weeks, or long-term toxicity or VF with this switch regimen are low and no unexpected mutations or patterns of mutations were selected in subjects with treatment failure.

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Conflict of interest statement

Competing Interests: JML has received research funding, consultancy fees, and lecture sponsorships from or has served on advisory boards for Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck Sharp & Dohme, and ViiV Healthcare. JRS has received research funding, consultancy fees, and lecture sponsorships from and has served on advisory boards for Abbott, Boehringer Ingelheim, Gilead Sciences, Janssen-Cilag, Bristol-Myers Squibb, ViiV Healthcare, and Pfizer. RP has received consulting fees from Pfizer and grant support from Pfizer, Roche Diagnostics, Siemens, Merck and Boehringer-Ingelheim. BC has received research funding, consultancy fees, and lecture sponsorships from and has served on advisory boards during the past 5 years for Abbott, Gilead Sciences, ViiV, Janssen-Cilag, and Merck Sharp & Dohme. The remaining authors declare no potential conflicts of interest. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Time to virological failure and treatment failure through the long term follow-up.
Virological failure was defined as two consecutive measurements of pVL >50 copies/mL. Treatment failure included subjects with virological failure, treatment discontinuations due to drug toxicity, and death.
See this image and copyright information in PMC

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