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Polly Clayden, HIV i-Base<\/strong><\/p>\n Atazanvir\/ritonavir (ATV\/r) 200\/100 mg is non-inferior ATV\/r 300\/100 mg according to results presented at AIDS 2015 by Torsak Bunupuradah on behalf of the LASA study group.<\/strong><\/p>\n Dr Bunupuradah explained that the standard dose of ATV\/r is associated with high exposure in Thai people in a previous study: median AUC 41 vs 72 h*mmg\/L in qhite and Thai people respectively receiving ATV\/r 300\/100 mg; but AUC 42 h*mmg\/L in Thai people receiving 200\/100 mg.<\/p>\n For the LASA study, 559 people receiving boosted protease inhibitors (PIs) with viral load 50 copies\/mL for at least 12 months were randomly assigned to receive ATV\/r 200\/100mg or ATV\/r 300\/100mg once daily with two NRTIs at 14 sites in Thailand.<\/p>\n Participants were assessed every 12 weeks until week 48. Virological failure was defined as confirmed viral load >200 copies\/mL. The primary endpoint was the proportion of participants with viral load <200 copies\/mL at 48 weeks. Non-inferiority was defined as the lower limit of the 95% confidence interval for the difference in viral failure above -10% by intention-to-treat (ITT) analysis at 48 weeks.<\/p>\n Of the randomised participants: 279 vs 280 received ATV 200\/100 mg and 300 mg respectively. For ITT analysis (non-completer=failure\/snapshot) 273 vs 277 participants were included and 259 vs 244 were included in the per protocol (PP) analysis, from the respective treatment arms.<\/p>\n At baseline, 85% of participants were receiving lopinavir\/ritonavir. Mean age was 42 years old, weight 59 kg, CD4 539 cells\/mm3, total bilirubin 0.85 mg\/dL. They had received PIs for five years previously and approximately half of the participants were women.<\/p>\n At week 48, in ITT analysis, the proportions of participants receiving ATV\/r 200\/100 mg vs ATV\/r 300 mg with viral load <200 copies\/mL were: 97.1% vs 96.4% (95% CI: 0.68, -2.29 to 3.65). The respective proportions with <50 copies\/mL were: 93.4% vs 91.7% (95% CI: 1.71, -2.67 to 6.09). In PP analysis the proportions with viral load < 200 copies\/mL were 98.5% vs 99.2% (95% CI: -0.72, -2.6 to 1.16). In non-completer=failure (snapshot) analysis the proportions with viral load <200 copies\/mL were 96% vs 91%, p=0.02, and <50 copies\/mL were 92% vs 86%, p=0.03.<\/p>\n A higher proportion of participants receiving ATV\/r 300\/100mg arm discontinued treatment overall: 2.6% vs 7.6%, p=0.01. The proportion was also higher for discontinuation due to clinical jaundice: 0.4% vs 2.2%, p=0.06. Only one participant receiving ATV\/r 200\/100 mg developed resistance to ATV: 150L, V82A and L90M. This participant had a self-reported history of non-adherence.<\/p>\n At week 48, mean total bilirubin was 1.9 (SD +1.1) vs 2.2 (SD +1.2) mg\/dL and proportions of participants with grade 3-4 hyperbilirubinemia (>3.12 mg\/dL) were 17% vs 35%, in the ATV\/r 200\/100 mg vs ATV\/r 300 mg arms respectively (both p<0.001). There was no difference in CD4, ALT, creatinine clearance, total cholesterol and triglycerides between treatment arms.<\/p>\n Based on the December 2014 antiretroviral price list at The Thai Red Cross Research Centre, the investigators calculated up to US$ 58 million savings over five years treating 20,000 people with the lower dose.<\/p>\n These results, including the cost analysis, make a compelling argument for lower dose ATV\/r in Thailand.<\/strong><\/p>\n Reference:<\/p>\n Bunupuradah T et al. Atazanavir\/ritonavir 200\/100 mg is non-inferior to atazanavir\/ritonavir 300\/100 mg in virologic suppressed HIV-infected Thai adults: a multicentre, randomized, open-label trial: LASA. 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention.19-22 July 2015. Vancouver, BC, Canada. Oral abstract TUAB0101. Webcast:<\/p>\nComment<\/h3>\n