Atazanavir early access programme: safety data from an HIV infected Greek population
Abstract number: 1135_251
Tserpe P., Tsogas N., Mangafas N., Lioni A., Chini M., Tsekes G., Lazanas M.C.
To report our experience regarding safety from the Atazanavir early expanded programme ran in our clinic from March 2003 to October 2004. We registered Grades 3 and 4 toxicities according to ACTG table of Grading Severity of Adult Adverse Experiences.
We enrolled 19 patients (CDC stage: 9A, 4B, 6C), 84.2% male, median age 43 years, median time on prior ART 95 months, median CD4 564 cells/ml, 36.8% with undetectable VL and 84% placed on a TDF-containing regimen. Reasons for starting on ATV/RTV were 47.4% hyperlipidemia, 26.3% virological failure and 26.3% toxicities. 10.5% were coinfected (1 HBV, 1 HCV). 4/19 initially received ATV 400 mg daily according to the protocol, changing 6 months later to ATV / RTV. Median time on ATV was 6.5 months.
5/19 patients had mild to moderate bilirubin elevations (2/5 were on IDV) before enrollment. After the initiation of ATV/RTV 15/19 patients (78.9%) experienced grade 3 or 4 hyperbilirubinemia (due to elevation of indirect bilirubin), of whom 7 grade 3 (36.8%) and 8 grade 4 (42.1%). Jaundice/scleral icterus was noticed in 10/19 (52.6%). 14/15 patients (93.3%) manifested hyperbilirubinemia within 12 weeks. 4/19 patients (21%) discontinued ATV: 3/4 due to protocol requirements, and 1/4 due to patient's request (scleral icterus, esthetic reasons). No other side effects were noted (transaminase elevations, rash, gastrointestinal disorders, dizziness, myalgia or ECG changes). Total bilirubin was returned to normal in all four patients after discontinuation of ATV.
ATV was safe and well tolerated. Almost 8/10 patients experienced severe hyperbilirubinemia (4/10 grade 4). 1/2 patients experienced jaundice/ scleral icterus. No relation between the above side effects and coinfection with HBV and HCV was noted. 1/5 discontinued ATV, mainly due to protocol requirements. ATV seems to be a more potent inhibitor of the uridine diphosphate-glucoronosyl-transferase than IDV. These data in our study revealed a significantly higher percentage of severe hyperbilirubinemia and jaundice from ATV use than previous studies.
|Session name:||XXIst ISTH Congress|
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