A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)

Summary

This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected, HLA-B\*5701 negative subjects for 48 weeks.

Timeline

Start

2010-04

Primary completion

2012-06

Completion

2012-12

Outcome

Met primary endpoint

paper After 24 weeks, ABC/3TC+ATV (n = 199) was non-inferior to TDF/FTC+ATV/r (n = 97) by both the primary analysis PMID 24825167 ↗

Publications

• Background Robertson K, Maruff P, Wohl D, et al. Similar cognition outcomes after 24 weeks for tenofovir/FTC + atazanavir/r (ATV/r)-experienced HIV+ subjects or subjects simplifying to abacavir/3TC+ATV. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.
• Results D. Wohl, L. Bhatti, P. Maruff, K. Robertson, C. Small, H. Edelstein, H. Zhao, D. Margolis, L. Ross, M. Shaefer, on behalf of the ASSURE (EPZ113734) Study Team. Prevalence of HIV Associated Neurocognitive Disorders (HAND) in Virologically Suppressed HIV+ Individuals. 19th International AIDS Conference; July 22-27, 2012; Washington, DC. Poster WEPE092.
• Results C. B. Small, D. Wohl, D. A. Margolis, B. Wine, L. L. Ross, H. Zhao, and M. S. Shaefer. Prevalence of HLA-B*5701 Allele in HIV-infected Subjects in North America and Reductions in Risk for Development of Abacavir Associated Hypersensitivity Reaction (ABC HSR). 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy; September 9-12, 2012; San Francisco, CA. Poster H-895
• Results D. Wohl, L. Bhatti, C. B. Small, H. Edelstein, H. Zhao, D. A. Margolis, L. L. Ross, M.S. Shaefer. Simplification to Abacavir/Lamivudine (ABC/3TC) + Atazanavir (ATV) from Tenofovir/Emtricitabine (TDF/FTC) + ATV/Ritonavir (RTV, /r) Maintains Viral Suppression and Improves Bone Biomarkers. 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy; September 9-12, 2012; San Francisco, CA. Oral presentation H-556c.
• Small CB, Margolis DA, Shaefer MS, Ross LL. HLA-B*57:01 allele prevalence in HIV-infected North American subjects and the impact of allele testing on the incidence of abacavir-associated hypersensitivity reaction in HLA-B*57:01-negative subjects. BMC Infect Dis. 2017 Apr 11;17(1):256. doi: 10.1186/s12879-017-2331-y.
• Wohl DA, Bhatti L, Small CB, Edelstein H, Zhao HH, Margolis DA, DeJesus E, Weinberg WG, Ross LL, Shaefer MS. Simplification to abacavir/lamivudine + atazanavir maintains viral suppression and improves bone and renal biomarkers in ASSURE, a randomized, open label, non-inferiority trial. PLoS One. 2014 May 13;9(5):e96187. doi: 10.1371/journal.pone.0096187. eCollection 2014.

Drugs

Indications