Randomised study to assess the efficacy and safety of once-daily etravirine-based regimen as a switching strategy in HIV-infected patients receiving a protease inhibitor-containing regimen. Etraswitch study

Abstract

Background: Etravirine (ETR) was approved for patients with virological failure and antiretroviral resistance mutations. It has also shown antiviral efficacy in antiretroviral-naïve patients. However, data on the switching from protease inhibitors (PI) to ETR are lacking.

Methods: HIV-1-infected patients with suppressed viral load (VL) during a PI-containing regimen (>12 months) and no previous virological failure were randomized to switch from the PI to ETR (400 mg/day, dissolved in water) (ETR group, n = 22) or to continue with the same regimen (control group, n = 21). Percentage of patients with VL ≤ 50 copies/mL were assessed at week 48, as well as changes in CD4 T-cell counts and metabolic profile.

Results: We included 43 patients [72.9% male, 46.3 (42.2; 50.6) years]. Two patients receiving ETR (grade-1 diarrhea and voluntary discontinuation) and another in the control group (simplification) discontinued therapy early. No patients presented virological failure (two consecutive VL>50 copies/mL); treatment was successful in 95.2% of the control group and 90.9% of the ETR group (intention-to-treat analysis, missing = failure) (p = 0.58). CD4+ T-cell counts did not significantly vary [+49 cells/µL in the ETR group (p = 0.25) and -4 cells/µL in the control group (p = 0.71)]. The ETR group showed significant reductions in cholesterol (p<0.001), triglycerides (p = <0.001), and glycemia (p = 0.03) and higher satisfaction (0-10 scale) (p = 0.04). Trough plasma concentrations of ETR were similar to observed in studies using ETR twice daily.

Conclusion: Switch from a PI-based regimen to a once-daily combination based on ETR maintained undetectable VL during 48 weeks in virologically suppressed HIV-infected patients while lipid profile and patient satisfaction improved significantly.

Trial registration: ClinicalTrials.gov NCT01034917.

Conflict of interest statement

Competing Interests: I have read the journal’s policy and have the following conflicts: (Transparency declarations) AB has received lecture fees from Bristol Myers Squibb. BC has been a consultant on advisory boards or participated in speakers bureaus or conducted clinical trials with Boehringer-Ingelheim, Abbott, GlaxoSmithKline, Gilead, Janssen, Merck, Shionogi and ViiV Healthcare. EN has received research funding, consultancy fees, or lecture sponsorships from Gilead, Roche, Bristol Myers Squibb, GlaxoSmithKline, Tibotec, Abbott, Merck and Boehringer-Ingelheim. RP has received research funding, consultancy fees, or lecture sponsorships from Gilead, Pfizer, ViiV Healthcare, Roche Diagnostics, Siemens, Merck and Boehringer-Ingelheim. JM has been a consultant on advisory boards with Abbott, Jansen Cilag, Bristol Myers Squibb, ViiV, Gilead and MSD and consultancy from Jansen and Abbott, PE, JP, NPA, GS and AO declared that no competing interests exist. Preliminary results of this study were presented in poster form at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy, 17–21 September, 2011 (Chicago, USA).]. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.