Skip Navigation LinksHome > April 24, 2014 - Volume 28 - Issue 7 > Week 48 results from a randomized clinical trial of rilpivir...
AIDS:
doi: 10.1097/QAD.0000000000000169
Clinical Science

Week 48 results from a randomized clinical trial of rilpivirine/emtricitabine/tenofovir disoproxil fumarate vs. efavirenz/emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV-1-infected adults

Cohen, Calvina; Wohl, Davidb; Arribas, Jose R.c; Henry, Keithd; Van Lunzen, Jane; Bloch, Markf; Towner, Williamg; Wilkins, Edmundh; Ebrahimi, Ramini; Porter, Daniellei; White, Kirsteni; Walker, Ivani; Chuck, Susani; De-Oertel, Shampai; Fralich, Toddi

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Abstract

Objectives:

To compare the safety and efficacy of the two single-tablet regimens (STRs), rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) and efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF), in HIV-1-infected, treatment-naive adults.

Design:

This is a phase 3b, randomized, open-label, multicenter, international, 96-week study.

Methods:

Participants were randomized 1 : 1 to receive either RPV/FTC/TDF or EFV/FTC/TDF. The primary endpoint was the proportion of participants with HIV-1 RNA less than 50 copies/ml at week 48 by the Snapshot algorithm.

Results:

A total of 786 participants were randomized. RPV/FTC/TDF was noninferior to EFV/FTC/TDF (85.8 vs. 81.6%) at week 48 for HIV-1 RNA less than 50 copies/ml [difference 4.1%, 95% confidence interval (CI) −1.1 to 9.2%]. A statistically significant difference in efficacy favoring RPV/FTC/TDF was demonstrated for participants with baseline HIV-1 RNA 100 000 copies/ml or less [(n = 510) 88.8% RPV/FTC/TDF vs. 81.6% EFV/FTC/TDF (difference 7.2%, 95% CI 1.1–13.4%)]. In participants with baseline HIV-1 RNA more than 100 000 copies/ml (n = 276), RPV/FTC/TDF demonstrated noninferior efficacy compared with EFV/FTC/TDF (79.9 vs. 81.7%, respectively, difference −1.8%, 95% CI −11.1 to 7.5%). In the RPV/FTC/TDF arm, more virologic failure was observed as baseline HIV-1 RNA levels increased. There were more participants with emergent resistance in the RPV/FTC/TDF arm than in the EFV/FTC/TDF arm (4 vs. 1%, respectively). There were fewer discontinuations because of adverse events with RPV/FTC/TDF (2.5%) than with EFV/FTC/TDF (8.7%).

Conclusion:

In treatment-naive participants, RPV/FTC/TDF demonstrated noninferior efficacy and improved tolerability compared with EFV/FTC/TDF, as well as a statistically significant difference in efficacy for participants with baseline HIV-1 RNA 100 000 copies/ml or less at week 48.

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins

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