Efficacy and safety of treatment of chronic hepatitis C with sofosbuvir and ribavirin with or without peginterferon: a French prospective real-life cohort study of unselected 211 patients.

INTRODUCTION: Sofosbuvir is the first directly-acting antiviral for the treatment of hepatitis C virus. First, the regimens were combinations with sofosbuvir+ribavirin (SR) or with sofosbuvir+ribavirin and pegylated-interferon α-2a (SPR) with cure rates around 90%. The aim of this study was to report the results of these combinations in 'real-life' in France. MATERIALS AND METHODS: Main features of patients treated with SR or SPR in 24 hospitals were collected. Undetectable hepatitis C virus week 12 viral load after treatment defined sustained virological response (SVR12). Statistics were performed using StatView software for descriptive analysis and χ for the sub-groups comparisons. RESULTS: Two hundred and eleven patients were analyzed. The average age was 56.1. One hundred and seventy-one (89%) patients had a fibrosis score of at least 3. Seventy-nine patients were infected by a genotype 1 (G1). One hundred and thirteen patients were treated with SR and 95 with SPR. In naive patients: with SPR for 12 weeks, SVR12 was 93% in G1, 100% in G3 and 83% in G4. With SR for 12 weeks, SVR12 was 100% in G2 patients (6/6). The safety of these regimens was satisfactory with only two patients who had to stop P due to severe side effects. Multivariate analysis shows a higher SVR in SPR versus SR (odds ratio = 1.28; P = 0.05) and in G2 or G3 versus others (odds ratio = 1.56; P = 0.04). Moreover, Child-Pugh score B or C (P = 0.02), platelets count under 100G/l (P = 0.05) or a past event of ascites (P = 0.04) was independently associated with less SVR. CONCLUSION: This multicenter large study confirms the good results of SR for 12 weeks in G2 naive patients. Finally, a decompensated cirrhosis, a past event of ascites and a baseline low platelet count were strongly associated with poor response.

Satisfaction of patients treated for chronic hepatitis C with the peginterferon alfa-2b pen device: the VISA observational study.

OBJECTIVES: This observational study aimed at evaluating the satisfaction of patients with chronic hepatitis C using the peginterferon (peg-IFN) alfa-2b pen device. METHODS: Consecutive patients were included when prescribed the pen device. Self-administered questionnaires relating to the progress brought by the pen, convenience/comfort, and the mode and security of injection were completed after the first injection and at 12 weeks. RESULTS: Six hundred and forty eight patients aged 45.7 +/- 12.1 years completed the 1st questionnaire; 70% were naive for any hepatitis C treatment. Five hundred and twenty five (81%) patients completed the 2nd questionnaire. Adherence to the pen device was >or=80% in more than 80% of the patients. Most (85%) patients declared that the pen brought important progress compared to traditional syringes. Satisfaction was high after the 1st injection and further increased 12 weeks later, with ease of use scoring 7.7 then 8.0 (P=0.007, 10-point scale), and rapidity of use scoring 8.0 then 8.2 (P=0.008); less painful injection scoring 7.9 at both time points. The proportion of self-injectors (no intervention of a health professional) increased from 32% to 58% (P<0.0001). Reasons for self-injecting were: easier injection (58%), no product/syringe handling (50%/41%), and assurance of exact dosing (45%). CONCLUSION: Patients were satisfied with the peg-IFN alfa-2b pen device. The proportion of self-injectors doubled over 12 weeks. Good treatment adherence, which is mandatory for therapeutic success, is expected from use if this device.

Treatment of chronic hepatitis C with pegylated interferon and ribavirin in treatment-naive patients in 'true life': a plea in favor of independent postmarketing evaluations.

BACKGROUND: Results of treatments for chronic hepatitis C virus are only estimated and disclosed from pivotal trials. AIM: To report the 'true life' results of pegylated interferon and ribavirin in treatment-naive patients. METHODS: A prospective, multicenter observatory in 22 general hospitals. RESULTS: Five-hundred and one patients were included, with 309 men (62%), aged 46 ± 11 years, weighting 70 ± 13 kg, infected with the following hepatitis C virus genotypes: 1 (50%), 2 (12%), 3 (28%), 4 (7.5%), 5 (0.6%). Liver biopsy, available in 436 patients showed stage F3 fibrosis in 24% and F4 in 13%. Two-hundred and seven patients had a comorbid condition. Treatment consisted of interferon alpha 2b in 340 patients and interferon alpha 2a in 161 patients. Dose reductions were necessary in 145 patients (29%). Treatment was prematurely interrupted in 145 patients (29%) owing to lack of efficacy (n =72) or side-effects (n =73). Sustained virological response (SVR) rates were 50% for all patients, and 37.1, 70.5, and 71% for patients with genotype 1, 2 and 3, respectively. At multivariate analysis, age, genotype, and fibrosis severity were the only independent factors of SVR. CONCLUSION: In true life, patients are older and more severe, and SVR is about 10% lower than in pivotal trials.

Occurrence of porphyria cutanea tarda during peginterferon/ribavirin therapy for chronic viral hepatitis C.

Porphyria cutanea tarda (PCT) is a metabolic disorder characterized by a reduced hepatic activity of uroporphynogen decarboxylase (URO-D), an enzyme of the heme synthesis. The clinical features of PCT may be brought into light by hepatic injury induced by hepatitis C virus (HCV). A significant association between HCV and PCT is well recognized, although the role of HCV in the appearance of PCT is still debated because confounding factors often coexist, such as alcohol, other viruses, drugs or iron overload (). HCV therapy may improve PCT although PCT was rarely reported as a de novo occurrence during an interferon/ribavirin therapy (Jessner et al. Hepatology 2002;36:1301-1302); here, we describe two such other cases.