BACKGROUND: Selection of first-line antiretroviral therapy requires consideration of efficacy as well as effects on lipids given the increased concern about cardiovascular risk in HIV-1 patients. METHODS: ARTEN is a randomized, open-label, non-inferiority trial that compares nevirapine (NVP) 200 mg twice daily or 400 mg once daily to atazanavir/ritonavir (ATZ/r) 300 mg/100 mg once daily, each combined with fixed-dose tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg once daily, in antiretroviral-naive HIV-1 patients with CD4(+) T-cell counts <400 (men) and <250cells/mm(3) (women). The primary end point was plasma HIV RNA<50 copies/ml at two consecutive visits prior to week 48. RESULTS: A total of 569 patients were randomized and treated. Overall, 66.8% of NVP and 65.3% of ATZ/r patients achieved the primary end point (difference 1.9%, 95% CI -5.9-9.8%). Similar rates of serious adverse events were observed (9.6% on NVP versus 8.8% on ATZ/r), although discontinuations due to adverse events were more frequent with NVP than ATZ/r (13.6% versus 3.6%, respectively). None of the 28 patients virologically failing ATZ/r selected resistance mutations, while they were selected in 29/44 patients virologically failing NVP. NVP induced a significantly greater increase in high-density lipoprotein cholesterol (HDL-c) and apolipoprotein A1 from baseline than ATZ/r, whereas triglycerides increased significantly more with ATZ/r than NVP. Mean change from baseline in TC:HDL-c ratio was -0.24 for NVP and 0.13 for ATZ/r (P=0.0001). CONCLUSIONS:NVP demonstrated at week 48 non-inferior antiviral efficacy compared with ATZ/r when given along with TDF/FTC, despite more drug-related discontinuations with NVP than ATZ/r. NVP was associated with a lower atherogenic lipid profile than ATZ/r although resistance mutations were more frequently selected with NVP than ATZ/r.
RCT Entities:
BACKGROUND: Selection of first-line antiretroviral therapy requires consideration of efficacy as well as effects on lipids given the increased concern about cardiovascular risk in HIV-1patients. METHODS:ARTEN is a randomized, open-label, non-inferiority trial that compares nevirapine (NVP) 200 mg twice daily or 400 mg once daily to atazanavir/ritonavir (ATZ/r) 300 mg/100 mg once daily, each combined with fixed-dose tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg once daily, in antiretroviral-naive HIV-1patients with CD4(+) T-cell counts <400 (men) and <250 cells/mm(3) (women). The primary end point was plasma HIV RNA<50 copies/ml at two consecutive visits prior to week 48. RESULTS: A total of 569 patients were randomized and treated. Overall, 66.8% of NVP and 65.3% of ATZ/rpatients achieved the primary end point (difference 1.9%, 95% CI -5.9-9.8%). Similar rates of serious adverse events were observed (9.6% on NVP versus 8.8% on ATZ/r), although discontinuations due to adverse events were more frequent with NVP than ATZ/r (13.6% versus 3.6%, respectively). None of the 28 patients virologically failing ATZ/r selected resistance mutations, while they were selected in 29/44 patients virologically failing NVP. NVP induced a significantly greater increase in high-density lipoprotein cholesterol (HDL-c) and apolipoprotein A1 from baseline than ATZ/r, whereas triglycerides increased significantly more with ATZ/r than NVP. Mean change from baseline in TC:HDL-c ratio was -0.24 for NVP and 0.13 for ATZ/r (P=0.0001). CONCLUSIONS: NVP demonstrated at week 48 non-inferior antiviral efficacy compared with ATZ/r when given along with TDF/FTC, despite more drug-related discontinuations with NVP than ATZ/r. NVP was associated with a lower atherogenic lipid profile than ATZ/r although resistance mutations were more frequently selected with NVP than ATZ/r.
Authors: Álvaro H Borges; Andreas Lundh; Britta Tendal; John A Bartlett; Nathan Clumeck; Dominique Costagliola; Eric S Daar; Patrícia Echeverría; Magnus Gisslén; Tania B Huedo-Medina; Michael D Hughes; Katherine Huppler Hullsiek; Paul Khabo; Stephanus Komati; Princy Kumar; Shahin Lockman; Rodger D MacArthur; Franco Maggiolo; Alberto Matteelli; Jose M Miro; Shinichi Oka; Kathy Petoumenos; Rebekah L Puls; Sharon A Riddler; Paul E Sax; Juan Sierra-Madero; Carlo Torti; Jens D Lundgren Journal: Clin Infect Dis Date: 2016-04-18 Impact factor: 9.079
Authors: Adrian V Hernandez; Vinay Pasupuleti; Abhishek Deshpande; Priyaleela Thota; Jaime A Collins; Jose E Vidal Journal: PLoS One Date: 2013-05-03 Impact factor: 3.240
Authors: Shahin Lockman; Michael Hughes; Fred Sawe; Yu Zheng; James McIntyre; Tsungai Chipato; Aida Asmelash; Mohammed Rassool; Sylvester Kimaiyo; Douglas Shaffer; Mina Hosseinipour; Lerato Mohapi; Francis Ssali; Margret Chibowa; Farida Amod; Elias Halvas; Evelyn Hogg; Beverly Alston-Smith; Laura Smith; Robert Schooley; John Mellors; Judith Currier Journal: PLoS Med Date: 2012-06-12 Impact factor: 11.069