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Patient-reported outcomes after simplification to a single tablet regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir DF (TDF)

Purpose of the study

To assess patient (pt) reported outcomes in AI266073, a 48-week, prospective, randomized, open-label, multicenter study.


Pts on stable antiretroviral therapy (ART) with HIV-1 RNA <200 c/mL for >3 months were randomized (2:1) to EFV/FTC/TDF (single tablet regimen) or to remain on their baseline regimen (SBR) and were stratified by prior PI- or NNRTI-based therapy. In addition to efficacy/safety, the following were collected from both study arms: adherence by visual analog scale, quality of life by SF-36(v2) survey, a 20-item self-reported HIV Symptoms Index, and the Perceived Ease of the Regimen for Condition questionnaire. In the EFV/FTC/TDF arm only, a protocol specific single-item Preference of Medication (POM) questionnaire was collected.

Summary of results

300 treated pts (EFV/FTC/TDF 203, SBR 97) were evaluated (prior PI/NNRTI 53%/47%); Through 48 weeks, 89% vs. 88% in the EFV/FTC/TDF vs. SBR arms, respectively, maintained HIV-1 RNA <200 c/mL by TLOVR (ITT; NC = F). Adherence in both arms at baseline and all visits was > 96%. Baseline SF-36 scores were similar to the general non-HIV infected population. There were no marked changes in adherence and SF-36 scores for either arm during the study. HIV Symptoms Index results demonstrated improvements in the proportion of pts randomized to EFV/FTC/TDF who experienced diarrhea or loose bowel movements (prior PI stratum: 52% at baseline; 32% at week 48 [p = 0.002]); bloating, pain, or gas in the stomach (p = 0.002); changes in the way their body looked (p = 0.002); and problems having sex (p = 0.032). There was a transient worsening of dizziness or lightheadedness symptoms (observed at week 4 only) in pts switched to EFV/FTC/TDF (p < 0.02), primarily in pts who switched from a PI-based regimen. Significantly more pts who received EFV/FTC/TDF considered it an easier regimen to take than their previous regimen (p < 0.001) at all study visits. By POM, pts randomized to EFV/FTC/TDF preferred this treatment over their previous regimen (p < 0.001) at all post-baseline visits; 85% reported at week 48 that EFV/FTC/TDF was "much better" than their previous regimen.


Simplification to EFV/FTC/TDF from a variety of ART maintained high levels of virologic suppression, adherence and quality of life through 48 weeks. Pts switched to EFV/FTC/TDF reported improvements in many HIV-related symptoms, found the new regimen easier to follow and preferred EFV/FTC/TDF over their previous ART regimen.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution 2.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Hodder, S., Mounzer, K., DeJesus, E. et al. Patient-reported outcomes after simplification to a single tablet regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir DF (TDF). JIAS 11 (Suppl 1), P63 (2008).

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