TY - JOUR
T1 - 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
AU - Cohen, Calvin
AU - Wohl, David
AU - Arribas, Jose R.
AU - Henry, Keith
AU - Van Lunzen, Jan
AU - Bloch, Mark
AU - Towner, William
AU - Wilkins, Edmund
AU - Ebrahimi, Ramin
AU - Porter, Danielle
AU - White, Kirsten
AU - Walker, Ivan
AU - Chuck, Susan
AU - De-Oertel, Shampa
AU - Fralich, Todd
PY - 2014/4/24
Y1 - 2014/4/24
N2 - 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.
AB - 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.
KW - HIV-1
KW - antiretroviral therapy
KW - efavirenz
KW - rilpivirine
KW - single-tablet regimens
KW - treatment-naive
UR - http://www.scopus.com/inward/record.url?scp=84897493853&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84897493853&partnerID=8YFLogxK
U2 - 10.1097/QAD.0000000000000169
DO - 10.1097/QAD.0000000000000169
M3 - Article
C2 - 24508782
AN - SCOPUS:84897493853
SN - 0269-9370
VL - 28
SP - 989
EP - 997
JO - AIDS
JF - AIDS
IS - 7
ER -
