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| |  Nevirapine Equally Effective, Improves Lipids Compared With Atazanavir in HIV: Presented at IAS By Charlene Laino CAPE TOWN, South Africa -- July 20, 2009 -- Nevirapine offers equal efficacy, with a more favourable lipid profile, compared with ritonavir-boosted atazanavir in the treatment of HIV-infected patients, researchers reported here at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention. The study “puts to rest the concerns over a potential lack of efficacy of nevirapine in combination with tenofovir/emtricitabine, and confirms that the combination of nevirapine and tenofovir/emtricitabine is a highly efficacious combination that offers significant benefit -- even more so to patients with cardiovascular risk,” said lead investigator Vicente Soriano, MD, Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain. The open-label, noninferiority Atazanavir/Ritonavir on a Background of Tenofovir and Emtricitabine (Truvada) Versus Nevirapine (ARTEN) trial is the first study to compare the 2 treatments, Dr. Soriano said in a late-breaking presentation on July 20. The study enrolled 569 patients: 188 received nevirapine 400 mg once daily, 188 received nevirapine 200 mg twice daily, and 193 received atazanavir/ritonavir 300/100 mg once daily. All participants also received tenofovir and emtricitabine. The study’s primary endpoint was virological response at 48 weeks of treatment, with response defined as a viral load of <50 copies/mL measured at 2 consecutive visits prior to week 48 and without subsequent rebound or change of therapy prior to week 48. For the primary analysis of the primary endpoint, the 2 nevirapine arms were combined. Sixty-seven percent of the 376 patients who received nevirapine in the study achieved the primary endpoint, compared with 65% of the 193 patients who received atazanavir/ritonavir (P = .63). The mean increase from baseline in high-density lipoprotein (HDL) cholesterol levels was 9.7 mg/dL among patients who received nevirapine and 3.9 mg/dL among patients who received atazanavir/ritonavir (P < .0001). Triglyceride levels decreased a mean of 0.2 mg/dL from baseline in the nevirapine group and increased 28.1 mg/dL in the atazanavir/ritonavir group (P < .0001). The mean increases in low-density lipoprotein cholesterol were 15 mg/dL in the nevirapine group and 10.5 mg/dL in the atazanavir/ritonavir group (P = .011). The mean change from baseline in total cholesterol to HDL ratio was -0.24 in the nevirapine group and 0.13 in the atazanavir/ritonavir group (P = .0001). The rate of serious adverse events at 48 weeks was 9.6% in the nevirapine group and 8.8% in the atazanavir/ritonavir group. A total of 13.6% of patients in the nevirapine arms and 3.6% of patients in the atazanavir/ritonavir arm discontinued treatment due to adverse events. In the nevirapine group, the most common adverse event was rash/eruptions/exanthema, experienced by 16.0% of patients. Of the 21 nevirapine-associated rashes that resulted in discontinuation, 16 (76.2%) were identified during the 2-week lead-in phase. Follow-up is planned to continue for a total of 144 weeks. Funding for this study was provided by Boehringer Ingelheim. [Presentation title: Prospective Comparison of Nevirapine and Atazanavir/Ritonavir Both Combined With Tenofovir DF/Emtricitabine in Treatment-Naïve HIV-1 Infected Patients: ARTEN Study Week 48 Results. Abstract LBPEB07]
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