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Abacavir–Lamivudine versus Tenofovir–Emtricitabine for Initial HIV-1 Therapy
- Publication Year :
- 2009
-
Abstract
- 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 a randomized, blinded equivalence study involving 1858 eligible patients, we compared four once-daily antiretroviral regimens as initial therapy for HIV-1 infection: abacavir-lamivudine or tenofovir disoproxil fumarate (DF)-emtricitabine plus efavirenz or ritonavir-boosted atazanavir. The primary efficacy end point was the time from randomization to virologic failure (defined as a confirmed HIV-1 RNA levelor = 1000 copies per milliliter at or after 16 weeks and before 24 weeks, oror = 200 copies per milliliter at or after 24 weeks).A scheduled interim review by an independent data and safety monitoring board showed significant differences in virologic efficacy, according to the NRTI combination, among patients with screening HIV-1 RNA levels of 100,000 copies per milliliter or more. At a median follow-up of 60 weeks, among the 797 patients with screening HIV-1 RNA levels of 100,000 copies per milliliter or more, the time to virologic failure was significantly shorter in the abacavir-lamivudine group than in the tenofovir DF-emtricitabine group (hazard ratio, 2.33; 95% confidence interval, 1.46 to 3.72; P0.001), with 57 virologic failures (14%) in the abacavir-lamivudine group versus 26 (7%) in the tenofovir DF-emtricitabine group. The time to the first adverse event was also shorter in the abacavir-lamivudine group (P0.001). There was no significant difference between the study groups in the change from the baseline CD4 cell count at week 48.In patients with screening HIV-1 RNA levels of 100,000 copies per milliliter or more, the times to virologic failure and the first adverse event were both significantly shorter in patients randomly assigned to abacavir-lamivudine than in those assigned to tenofovir DF-emtricitabine. (ClinicalTrials.gov number, NCT00118898.)
- Subjects :
- Adult
Male
medicine.medical_specialty
Efavirenz
Time Factors
Adolescent
Anti-HIV Agents
Organophosphonates
HIV Infections
Emtricitabine
Deoxycytidine
Article
chemistry.chemical_compound
Fractures, Bone
Young Adult
Double-Blind Method
immune system diseases
Abacavir
Internal medicine
Drug Resistance, Viral
medicine
Humans
Treatment Failure
Tenofovir
Analysis of Variance
Reverse-transcriptase inhibitor
business.industry
Adenine
virus diseases
Lamivudine
General Medicine
Abacavir/Lamivudine
Middle Aged
Viral Load
Virology
Dideoxynucleosides
Atazanavir
CD4 Lymphocyte Count
Drug Combinations
chemistry
Therapeutic Equivalency
HIV-1
RNA, Viral
Ritonavir
Female
business
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....1af34f114d6267711001166cce8def22