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Purpose: To evaluate clinical, immunological, and virological outcomes after first-line highly active antiretroviral therapy (HAART) with a regimen including either efavirenz (EFV) or lopinavir/ritonavir (LPV/r) in treament-naive adult patients in routine clinical care.    Method: An ongoing prospective, observational follow-up study included all patients starting their first antiretroviral therapy (ART) with any of the studied regimens from July 1998 to July 2004. The follow-up period was finalized in September 2006, when all patients completed an observation of at least 96 weeks. Mortality rates, CD4 counts, viral suppression (HIV RNA below 50 copies/mL), and discontinuation of any component of the regimen were compared at 48 and 96 weeks.    Results: Despite the worst immunological status of the LPV/r group patients at baseline, this regimen was at least as effective as the one based on EFV not only in terms of treatment durability but also in terms of virological responses, nevertheless with an apparently quicker immune recovery. In general terms, both regimens present similar tolerability and safety outcomes except for the higher risk of increasing triglyceride (TG) levels in the LPV/r group. Low durability was observed in both regimens.    Conclusion: In a routine clinical care setting, initial HAART containing LPV/r seems to present an effectiveness, tolerability, and toxicity similar to the one containing EFV.

Observational Study to Evaluate Clinical Outcomes After First-Line Efavirenz-or Lopinavir-Ritonavir-Based HAART in Treatment-Naive Patients