Background Limited data compare once-daily options for initial therapy for HIV-1. Objective To compare time to virologic failure; first grade-3 or -4 sign, symptom, or laboratory abnormality (safety); and change or discontinuation of regimen (tolerability) for atazanavir plus ritonavir with efavirenz-containing initial therapy for HIV-1. Design A randomized equivalence trial accrued from September 2005 to November 2007, with median follow-up of 138 weeks. Regimens were assigned by using a central computer, stratified by screening HIV-1 RNA level less than 100 000 copies/mL or 100 000 copies/mL or greater; blinding was known only to the site pharmacist. (ClinicalTrials.gov registration number: NCT00118898) Setting 59 AIDS Clinical Trials Group sites in the United States and Puerto Rico. Patients Antiretroviral-naive patients. Intervention Open-label atazanavir plus ritonavir or efavirenz, each given with with placebo-controlled abacavir–lamivudine or tenofovir disoproxil fumarate (DF)–emtricitabine. Measurements Primary outcomes were time to virologic failure, safety, and tolerability events. Secondary end points included proportion of patients with HIV-1 RNA level less than 50 copies/mL, emergence of drug resistance, changes in CD4 cell counts, calculated creatinine clearance, and lipid levels. Results 463 eligible patients were randomly assigned to receive atazanavir plus ritonavir and 465 were assigned to receive efavirenz, both with abacavir–lamivudine; 322 (70%) and 324 (70%), respectively, completed follow-up. The respective numbers of participants in each group who received tenofovir DF–emtricitabine were 465 and 464; 342 (74%) and 343 (74%) completed follow-up. Primary efficacy was similar in the group that received atazanavir plus ritonavir and and the group that received efavirenz and did not differ according to whether abacavir–lamivudine or tenofovir DF–emtricitabine was also given. Hazard ratios for time to virologic failure were 1.13 (95% CI, 0.82 to 1.56) and 1.01 (CI, 0.70 to 1.46), respectively, although CIs did not meet prespecified criteria for equivalence. The time to safety (P = 0.048) and tolerability (P < 0.001) events was longer in persons given atazanavir plus ritonavir than in those given efavirenz with abacavir–lamivudine but not with tenofovir DF–emtricitabine. Limitations Neither HLA-B*5701 nor resistance testing was the standard of care when A5202 enrolled patients. The third drugs, atazanavir plus ritonavir and efavirenz, were open-label; the nucleoside reverse transcriptase inhibitors were prematurely unblinded in the high viral load stratum; and 32% of patients modified or discontinued treatment with their third drug. Conclusion Atazanavir plus ritonavir and efavirenz have similar antiviral activity when used with abacavir–lamivudine or tenofovir DF–emtricitabine. Primary Funding Source National Institutes of Health.

BACKGROUND-The use of fixed-dose combination nucleoside reverse-transcriptase inhibitors (NRTIs) with a nonnucleoside reverse-transcriptase inhibitor or a ritonavir-boosted protease inhibitor is recommended as initial therapy in patients with human immunodeficiency virus type 1 (HIV-1) infection, but which NRTI combination has greater efficacy and safety is not known.

In the low HIV RNA stratum, times to virologic failure for ABC/3TC or TDF/FTC were not different with EFV or ATV/r. In the high stratum, virologic failure rate was significantly higher for ABC/3TC than for TDF/FTC when given with either EFV or ATV/r.

Problem drinking is associated with decreased medication adherence, particularly with taking medications off schedule during the previous week. Clinicians should assess for alcohol problems, link alcohol use severity to potential adherence problems, and monitor outcomes in both alcohol consumption and medication adherence.

OBJECTIVE:To examine the relation between problem drinking and medication adherence among persons with HIV infection. DESIGN:Cross-sectional survey.SETTING/PARTICIPANTS: Two hundred twelve persons with HIV infection who visited 2 outpatient clinics between December 1997 and February 1998. MEASUREMENTS AND MAIN RESULTS:Nineteen percent of subjects reported problem drinking during the previous month, 14% missed at least 1 dose of medication within the previous 24 hours, and 30% did not take their medications as scheduled during the previous week. Problem drinkers were slightly more likely to report a missed dose (17% vs 12 %, P = .38) and significantly more likely to report taking medicines off schedule (45% vs 26%, P = .02). Among drinking subtypes, taking medications off schedule was significantly associated with both heavy drinking (high quantity/frequency) (adjusted odds ratio [OR], 4.70; 95% confidence interval [95% CI], 1.49 to 14.84; P < .05) and hazardous drinking (adjusted OR, 2.64; 95% CI, 1.07 to 6.53; P < .05). Problem drinkers were more likely to report missing medications because of forgetting (48% vs 35%, P = .10), running out of medications (15% vs 8%, P = .16), and consuming alcohol or drugs (26 % vs 3 %, P < .001).CONCLUSION: Problem drinking is associated with decreased medication adherence, particularly with taking medications off schedule during the previous week. Clinicians should assess for alcohol problems, link alcohol use severity to potential adherence problems, and monitor outcomes in both alcohol consumption and medication adherence.