1208 Adherence to combination therapy increases sustained response in patients with chronic hepatitis C (original) (raw)

AASLD ABSTRACTS 741A for 36 weeks. Ribavirin 1000 or 1200 mg/day was coadministered throughout the 48-week treatment period. Patients who failed to achieve an on-treatment virological response, defined as undetectable HCV RNA levels (<50 IU/mL, COBAS AMPLICOR ® HCV Test, v2.0 [Roche Diagnostics]) after 12 weeks, discontinued treatment. Results Seventy-five patients were randomized to treatment. Three patients did not receive study medication, thus 72 patients were included in the analysis (Table). The rates of virological response after 12 weeks of treatment with peginterferon alfa-2a (40KD) increased in a dose-dependent manner: 21.4% in the 180/~g/week group, 35% in the 270 /~g/week group, and 45.8% in the 360 /~g/week group. Overall, the response rates were higher in patients with low baseline viral loads (-<800,000 IU/mL). The incidence of adverse events, severe adverse events, and laboratory abnormalities including neutropenia and thrombocytopenia were similar among the three treatment groups. Asthenia (40.3%), headache (34.7%), fever (31.9%), and myalgia (27.8%) were the most frequently reported adverse events overall. Reductions in the dosage of peginterferon alfa-2a (40KD) because of adverse events occurred in 9, 2 and 3 patients in the 180, 270 and 360/~g/week groups, respectively. At week 12, grade 3 neutropenia was detected in 8 (29.6%), 5 (27.8%) and 3 (13%) patients treated with peginterferon alfa-2a (40KD) 180, 270 or 360/~g/week. No patients in any group had grade 4 neutropenia, or grade 3 or 4 thrombocytopenia after 12 weeks. Conclusions In patients infected with HCV genotype I who have failed to respond to previous treatment with IFN/ribavirin, peginterferon alfa-2a (40KD) (PEGASYS ®) and ribavirin (COPEGUS ®) can suppress HCV RNA levels below the limit of detection. The highest rate of virological response at week 12 was obtained in patients treated with peginterferon alfa-2a (40KD) 360/~g/week. Peginterferon alfa-2a (40KD) was equally well-tolerated at doses of 180 to 360/~g/week. Baseline Characteristics and Virological Response at Week 12