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The ASSURE study: HIV ‐1 suppression is maintained with bone and renal biomarker improvement 48 weeks after ritonavir discontinuation and randomized switch to abacavir/lamivudine + atazanavir
Author(s) -
Wohl DA,
Bhatti L,
Small CB,
Edelstein H,
Zhao HH,
Margolis DA,
DeJesus E,
Weinberg WG,
Ross LL,
Shaefer MS
Publication year - 2016
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/hiv.12281
Subject(s) - medicine , atazanavir , abacavir , ritonavir , discontinuation , emtricitabine , lamivudine , cobicistat , tolerability , adverse effect , viral load , gastroenterology , pharmacology , human immunodeficiency virus (hiv) , virology , antiretroviral therapy , hepatitis b virus , virus
Objectives HIV treatment guidelines endorse switching or simplification of antiretroviral therapy in therapy‐experienced patients with suppressed viraemia; ritonavir discontinuation may also enhance tolerability and reduce long‐term adverse events ( AEs ). This open‐label, multicentre, noninferiority study enrolled HIV ‐1‐infected, treatment‐experienced adults with confirmed HIV ‐1 RNA ≤ 75 HIV ‐1 RNA copies/mL currently receiving tenofovir/emtricitabine + atazanavir/ritonavir ( TDF / FTC + ATV /r) for ≥ 6 months with no reported history of virological failure. Methods Participants were randomized 1:2 to continue current treatment or switch to abacavir/lamivudine + atazanavir ( ABC /3TC + ATV ). Endpoints included the proportion of participants with HIV ‐1 RNA < 50 copies/mL by time to loss of virological response ( TLOVR ), AEs , fasting lipids, and inflammatory, coagulation, bone and renal biomarkers. Results After 48 weeks, 76% (152 of 199) of ABC /3TC + ATV ‐treated and 79% (77 of 97) of TDF / FTC + ATV /r‐treated participants had HIV ‐1 RNA < 50 copies/mL ( TLOVR ; P = 0.564). Other efficacy analyses yielded similar results. Rates of new grade 2–4 AEs were 45% in both groups, but an excess of hyperbilirubinaemia made the rate of treatment‐emergent grade 3–4 laboratory abnormalities higher with TDF / FTC + ATV /r (36%) compared with ABC /3TC + ATV (19%). Most fasting lipid levels remained stable over time; high‐density lipoprotein ( HDL ) cholesterol increased modestly in ABC /3TC + ATV ‐treated participants. Bone and renal biomarkers improved significantly between baseline and week 48 in participants taking ABC /3TC + ATV and were stable in participants taking TDF / FTC + ATV /r. No significant changes occurred in any inflammatory or coagulation biomarker within or between treatment groups.Conclusions The ABC /3TC + ATV treatment‐switch group had similar viral suppression rates up to 48 weeks to the TDF / FTC + ATV /r comparator group, with lower rates of moderate‐ to high‐grade hyperbilirubinaemia and improvements in bone and renal biomarkers.