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Pegasys plus Ribavirin in African-Americans
Reported by Jules Levin
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Lennox Jeffers compared the efficacy and safety of Pegasys/ribavirin combination therapy for treating HCV genotype 1 patients non-Hispanic African-American and non-Hispanic Caucasian patients. This was a prospective, open-label, multicenter study in previously untreated patients with elevated ALT. Patients received Pegasys 180 ug/kg once weekly plus ribavirin 1000 or 1200 mg daily based on weight (<75 kg gets 1000 mg vs >75 kg gets 1200 mg ribavirin per day). Patients were randomized on a 3:1 ratio (African-Americans: Caucasians). There were 78 African-Americans in the study and 28 Caucasians. Treatment is for 48 weeks, with an additional 24 week followup period to evaluate the sustained response.
There were some differences in the baseline characteristics between the African-Americans and Caucasians. Average age was about the same, 45years. Weight was 90 kg in African-Americans and 84 kg in Caucasians (kg=2.2 lbs). There were more men among the Blacls than thw whites, men don't respond to therapy as well as women: 71% of African-Americans were men vs 60% of Caucasians were men. Average ALT was about the same: 63. Apparently more Blacks had higher viral load: 57% of African-Americans had viral load >1 million IU/ml vs 42% of Caucasians.
RESULTS After 48 Weeks of Treatment (ITT analysis)
--32% of African-Americans vs 53% of Caucasians had a viral response (<50 IU/ml)
--44% of African-Americans had 2 log or greater drop in viral load vs 60% for Caucasians
These are results at the end of treatment, so we await the sustained response rates evaluated after 24 weeks following stopping therapy.
No unexpected side effects or safety concerns were noted. There were 17 adverse events reported in 12 patients including acute abdomen, appendicitis, atrial finrilation, cardiac arrest, chest pain (2), thrombocytopenia, cellulitis, sepsis, acute respiratory distress syndrome, dyspnea, chronic cholecystitis, small intestinal obstruction, wrist fracture, traumatic brain damage, uterine fibroids, and dehydration. Two serious adverse events were deemed probably or possibly related to treatment: thrombocytopenia and chest pain. One serious adverse event (thromocytopenia) resulted in premature discontinuation. 21 patients discontinued therapy: 19% of african-Americans and 21% of Caucasians. 3.8% of discontinuations in African-Americans vs 14% in Caucasians were due to adverse events/intercurrent illnesses. The study investigators concluded African-Americans appear to tolerate the therapy better than Caucasians; these response rates appear higher than previously reported from studies. But African-Americans appear to have lower response rates than Caucasians. Jeffers suggested that this may be indicative of a slower viral decline decay curve for African-Americans.
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