Journal of clinical and translational hepatology · 2014
Patient Characteristics, Safety, and Tolerability with Telaprevir Treatment for HCV in the Clinic: a Retrospective, Multicenter Study.
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Flamm Steven L, Pockros Paul J, Bengtsson Leif, Friedman Mark
Аннотация
BACKGROUND AND AIMS: There is a paucity of information regarding similarities and differences between patients from the phase 3 studies of telaprevir and those receiving telaprevir in clinical practice.
METHODS: This retrospective chart review evaluated baseline characteristics and follow-up safety and tolerability data for patients with hepatitis C virus (HCV) infection treated with telaprevir and peginterferon alfa and ribavirin (PR) in clinical practice.
RESULTS: In total, 338 charts from patients at four academic and three community US treatment centers who received telaprevir and PR and had at least 12 weeks of follow-up data were included; 62% were from academic centers and 38% were from community centers. Of the 338 patients, 269 completed 12 weeks of telaprevir and PR; 32 discontinued due to adverse events. Mean age was 55 years; patients were predominantly white (79.3%) males (58.9%) with genotype 1a HCV infection (61.8%); 35.5% were reported to have cirrhosis at baseline; and 55.3% previously received PR. Hypertension and depression were the most common comorbidities. Patient characteristics outside the per-protocol minimum criteria used in the phase 3 studies of telaprevir were, e.g., hemoglobin, 9.2%; albumin, 5.3%; platelets, 11.5%; and neutrophil count, 5.6%. Adverse events occurred in 329/338 (97.3%) patients, with anemia, fatigue, nausea, and rash being the most common. Of 38 hospitalizations, 26 were deemed related to telaprevir and PR. Three patients died due to pneumonia, septic shock, and hepatorenal syndrome (n=1 each).
CONCLUSIONS: These findings complement those reported from rigorous, randomized controlled studies with telaprevir-based treatment and provide a general assessment of similarities and/or differences between patients from the phase 3 studies of telaprevir and those treated with telaprevir in clinical practice.
METHODS: This retrospective chart review evaluated baseline characteristics and follow-up safety and tolerability data for patients with hepatitis C virus (HCV) infection treated with telaprevir and peginterferon alfa and ribavirin (PR) in clinical practice.
RESULTS: In total, 338 charts from patients at four academic and three community US treatment centers who received telaprevir and PR and had at least 12 weeks of follow-up data were included; 62% were from academic centers and 38% were from community centers. Of the 338 patients, 269 completed 12 weeks of telaprevir and PR; 32 discontinued due to adverse events. Mean age was 55 years; patients were predominantly white (79.3%) males (58.9%) with genotype 1a HCV infection (61.8%); 35.5% were reported to have cirrhosis at baseline; and 55.3% previously received PR. Hypertension and depression were the most common comorbidities. Patient characteristics outside the per-protocol minimum criteria used in the phase 3 studies of telaprevir were, e.g., hemoglobin, 9.2%; albumin, 5.3%; platelets, 11.5%; and neutrophil count, 5.6%. Adverse events occurred in 329/338 (97.3%) patients, with anemia, fatigue, nausea, and rash being the most common. Of 38 hospitalizations, 26 were deemed related to telaprevir and PR. Three patients died due to pneumonia, septic shock, and hepatorenal syndrome (n=1 each).
CONCLUSIONS: These findings complement those reported from rigorous, randomized controlled studies with telaprevir-based treatment and provide a general assessment of similarities and/or differences between patients from the phase 3 studies of telaprevir and those treated with telaprevir in clinical practice.