Efficacy and safety of atazanavir, with or without ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients.
ABSTRACT Atazanavir (ATV), the first once-daily protease inhibitor approved for the treatment of HIV-1 infection, is recommended for use in antiretroviral (ARV) treatment-naive and -experienced patients. Study AI424-089 was a prospective, randomized, open-label, 96-week study comparing 2 ATV-based treatment regimens in ARV-naive HIV-infected patients.
Adults with HIV RNA levels > or =2000 copies/mL were randomized (1:1) to once-daily ATV at a dose of 300 mg with ritonavir at a dose of 100 mg (ATV300/RTV) or ATV at a dose of 400 mg (ATV400); both regimens included lamivudine and an investigational extended-release formulation of stavudine. The primary endpoint for this noninferiority study was the proportion of patients (response rate) with an HIV RNA load <400 copies/mL at week 48.
Response rates at week 48 were 86% and 85% on the ATV300/RTV and ATV400 regimens, respectively (difference estimate [95% confidence interval] = 1.5 [-8.2 to 11.1]). There were 3 and 10 patients with virologic failure in the ATV300/RTV and ATV400 groups, respectively. One patient (ATV400) developed phenotypic resistance to ATV associated with an I50L substitution. Adverse event-related discontinuations were 8% among ATV300/RTV-treated patients and <1% among ATV400-treated patients. Plasma lipid elevations were low with both regimens. Both regimens were well tolerated.
These findings demonstrate the safety and efficacy of the ATV300/RTV regimen and confirm the safety and efficacy of ATV400 in an ARV-naive patient population.
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ABSTRACT: Objectives. TEACH (NCT00896051) was a randomized, open-label, two-arm Phase II trial to investigate the pharmacokinetic interaction between etravirine and atazanavir/ritonavir and safety and efficacy in treatment-experienced, HIV-1-infected patients. Methods. After a two-week lead-in of two nucleoside reverse transcriptase inhibitors (NRTIs) and atazanavir/ritonavir 300/100 mg, 44 patients received etravirine 200 mg bid with one NRTI, plus atazanavir/ritonavir 300/100 mg or 400/100 mg qd (n = 22 each group) over 48 weeks. Results. At steady-state etravirine with atazanavir/ritonavir 300/100 mg qd or 400/100 mg qd decreased atazanavir C min by 18% and 9%, respectively, with no change in AUC24 h or C max versus atazanavir/ritonavir 300/100 mg qd alone (Day -1). Etravirine AUC12 h was 24% higher and 16% lower with atazanavir/ritonavir 300/100 or 400/100 mg qd, respectively, versus historical controls. At Week 48, no significant differences were seen between the atazanavir/ritonavir groups in discontinuations due to adverse events (9.1% each group) and other safety parameters, the proportion of patients with viral load <50 copies/mL (intent-to-treat population, noncompleter = failure) (50.0%, atazanavir/ritonavir 300/100 mg qd versus 45.5%, 400/100 mg qd), and virologic failures (31.8% versus 27.3%, resp.). Conclusions. Etravirine 200 mg bid can be combined with atazanavir/ritonavir 300/100 mg qd and an NRTI in HIV-1-infected, treatment-experienced patients without dose adjustment.AIDS research and treatment 01/2015; 2015:938628. DOI:10.1155/2015/938628
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ABSTRACT: Atazanavir is an attractive option for the treatment of Pediatric HIV infection, based on once daily dosing and the availability of a formulation appropriate for younger children. PACTG 1020A was a phase I/II open label study of atazanavir (ATV) (with/without ritonavir [RTV] boosting)-based treatment of HIV-infected children; here we report the long-term safety and virologic and immunologic responses.The Pediatric Infectious Disease Journal 09/2014; 34(2). DOI:10.1097/INF.0000000000000538 · 3.14 Impact Factor
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ABSTRACT: Aim of this study was to evaluate cardiovascular risk in HIV-infected patients treated with atazanavir or lopinavir, both boosted with ritonavir, in Poland.Background Introduction into clinical practice of cART has succeeded in decline in AIDS-related mortality and extended the life expectancy of patients living with HIV/AIDS. Observed, anyhow, side effects such as dyslipidemia and, as a result, cardiovascular disease seems to become predominant cause of mortality in this population.Materials and methodsThe study was a retrospective data analysis of HIV infected patients on ATV/r or LPV/r, treated between 1st of November 2004 and 31st of March 2009, and continued this treatment for at least 24 weeks.ResultsThe study population included 328 patients (82 women and 246 men) within age range between 23 and 75 years (mean 38.5 ± 9.2 years) divided into two groups: group A (148 patients on atazanavir 300 mg + ritonavir 100 mg/d) and group B (180 patients treated with lopinavir/ritonavir 800/200 mg/d).Changes in the level of cholesterol, triglycerides and glucose were significantly different in the treatment groups (p-value: 0.01, 0.009, 0.02 respectively). SCORE scale increase during observation did not differ statistically (p = 0.53). Increase in cholesterol and triglyceride levels was higher in the group B (17.0% vs 7.8% and 41.5% vs 16.8%) while the increase in the level of glucose was in the group A (5.2% vs 0.7%).Conclusion The study confirms differences in CV risk factors between different cART drugs and this should be considered during initiation of the therapy.11/2014; 14(1). DOI:10.1016/j.hivar.2014.10.002