Safety and efficacy of a 36-week induction regimen of abacavir/lamivudine and ritonavir-boosted atazanavir in HIV-infected patients

• Published in: HIV clinical trials Vol. 11; no. 2; p. 69
• Main Authors: Squires, Kathleen E, Young, Benjamin, DeJesus, Edwin, Bellos, Nicholas, Murphy, Daniel, Sutherland-Phillips, Denise H, Zhao, Henry H, Patel, Lisa G, Ross, Lisa L, Wannamaker, Paul G, Shaefer, Mark S
• Format: Journal Article
• Language: English
• Published: England 01.03.2010
• Subjects: Adolescent; Adult; Aged; Anti-HIV Agents - administration & dosage; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Atazanavir Sulfate; Dideoxynucleosides - administration & dosage; Dideoxynucleosides - adverse effects; Dideoxynucleosides - therapeutic use; Drug Administration Schedule; Drug Resistance, Viral; Drug Therapy, Combination; Female; HIV Infections - drug therapy; HIV Infections - virology; HIV-1 - drug effects; HIV-1 - enzymology; HIV-1 - genetics; HLA-B Antigens - analysis; Humans; Lamivudine - administration & dosage; Lamivudine - adverse effects; Lamivudine - therapeutic use; Male; Middle Aged; Mutation; Oligopeptides - administration & dosage; Oligopeptides - adverse effects; Oligopeptides - therapeutic use; Pyridines - administration & dosage; Pyridines - adverse effects; Pyridines - therapeutic use; Reverse Transcriptase Inhibitors - administration & dosage; Reverse Transcriptase Inhibitors - adverse effects; Reverse Transcriptase Inhibitors - therapeutic use; Ritonavir - adverse effects; Ritonavir - therapeutic use; RNA, Viral; Treatment Outcome; Viral Load; Young Adult
• ISSN: 1528-4336
• DOI: 10.1310/hct1102-69

The ARIES study assessed safety and efficacy of an induction regimen with atazanavir/ritonavir (ATV/RTV) + abacavir/lamivudine (ABC/3TC) followed by simplification to ATV + ABC/3TC in antiretroviral-naïve patients. This report includes a noncomparative analysis of all patients in the induction phase of the ARIES study through 36 weeks (clinicaltrials.gov: NCT00440947). This open-label study included 515 antiretroviral-naïve,HLA-B*5701-negative patients receiving a regimen of ATV 300 mg, RTV 100 mg, and ABC/3TC 600 mg/300 mg once daily for 36 weeks; eligible patients were then randomized to continue the induction regimen or simplify to ATV 400 mg plus ABC/3TC 600 mg/300 mg once daily. Eighty-six percent (442/515) of patients completed 36 weeks on study; 80% (410/515) achieved HIV RNA <50 copies/mL (84% and 76% of patients with baseline HIV RNA of < and >or=100,000 copies/mL achieved this endpoint). Virologic failure (VF) was uncommon (3%); treatment-emergent major protease inhibitor and nucleoside reverse transcriptase inhibitor mutations were detected in 0/15 and 4/15 patients, respectively. Median CD4+ cell increase was 171 (range, -176 to 718) cells/mm(3). Hyperbilirubinemia (13%), diarrhea (4%), nausea (2%), and rash (2%) were the most frequent drug-related Grade 2-4 adverse events. Few adverse events (3%) led to study discontinuation. Induction with ATV/RTV + ABC/3TC once daily provides an efficacious and well-tolerated regimen for the initial treatment of HIV.