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

Calvin Cohen; David Wohl; Jose R Arribas; Keith Henry; Jan Van Lunzen; Mark Bloch; William Towner; Edmund Wilkins; Ramin Ebrahimi; Danielle Porter; Kirsten White; Ivan Walker; Susan Chuck; Shampa De-Oertel; Todd Fralich

doi:10.1097/QAD.0000000000000169

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

Standard

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, Calvin; Wohl, David; Arribas, Jose R; Henry, Keith; Van Lunzen, Jan; Bloch, Mark; Towner, William; Wilkins, Edmund; Ebrahimi, Ramin; Porter, Danielle; White, Kirsten; Walker, Ivan; Chuck, Susan; De-Oertel, Shampa; Fralich, Todd.

In: AIDS, Vol. 28, No. 7, 24.04.2014, p. 989-997.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Cohen, C, Wohl, D, Arribas, JR, Henry, K, Van Lunzen, J, Bloch, M, Towner, W, Wilkins, E, Ebrahimi, R, Porter, D, White, K, Walker, I, Chuck, S, De-Oertel, S & Fralich, T 2014, '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', AIDS, vol. 28, no. 7, pp. 989-997. https://doi.org/10.1097/QAD.0000000000000169

APA

Cohen, C., Wohl, D., Arribas, J. R., Henry, K., Van Lunzen, J., Bloch, M., Towner, W., Wilkins, E., Ebrahimi, R., Porter, D., White, K., Walker, I., Chuck, S., De-Oertel, S., & Fralich, T. (2014). 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. AIDS, 28(7), 989-997. https://doi.org/10.1097/QAD.0000000000000169

Vancouver

Cohen C, Wohl D, Arribas JR, Henry K, Van Lunzen J, Bloch M et al. 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. AIDS. 2014 Apr 24;28(7):989-997. https://doi.org/10.1097/QAD.0000000000000169

Bibtex

@article{8398ad3b0a904d45b72f850ffb4e3faa,

title = "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",

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 100000 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 100000 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 100000 copies/ml or less at week 48.",

author = "Calvin Cohen and David Wohl and Arribas, {Jose R} and Keith Henry and {Van Lunzen}, Jan and Mark Bloch and William Towner and Edmund Wilkins and Ramin Ebrahimi and Danielle Porter and Kirsten White and Ivan Walker and Susan Chuck and Shampa De-Oertel and Todd Fralich",

year = "2014",

month = apr,

day = "24",

doi = "10.1097/QAD.0000000000000169",

language = "English",

volume = "28",

pages = "989--997",

journal = "AIDS",

issn = "0269-9370",

publisher = "Lippincott Williams and Wilkins",

number = "7",

}

RIS

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 100000 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 100000 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 100000 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 100000 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 100000 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 100000 copies/ml or less at week 48.

U2 - 10.1097/QAD.0000000000000169

DO - 10.1097/QAD.0000000000000169

M3 - SCORING: Journal article

C2 - 24508782

VL - 28

SP - 989

EP - 997

JO - AIDS

JF - AIDS

SN - 0269-9370

IS - 7

ER -