Faldaprevir and Deleobuvir for HCV Genotype 1 Infection

Abstract

BACKGROUND: Interferon-free regimens would be a major advance in the treatment of patients with chronic hepatitis C virus (HCV) infection. METHODS: In this phase 2b, randomized, openlabel trial of faldaprevir (a protease inhibitor) and deleobuvir (a nonnucleoside polymerase inhibitor), we randomly assigned 362 previously untreated patients with HCV genotype 1 infection to one of five groups: faldaprevir at a dose of 120 mg once daily and deleobuvir at a dose of 600 mg three times daily, plus ribavirin, for 16, 28, or 40 weeks (TID16W, TID28W, or TID40W, respectively); faldaprevir at a dose of 120 mg once daily and deleobuvir at a dose of 600 mg twice daily, plus ribavirin, for 28 weeks (BID28W); or faldaprevir at a dose of 120 mg once daily and deleobuvir at a dose of 600 mg three times daily, without ribavirin, for 28 weeks (TID28W-NR). The primary end point was a sustained virologic response 12 weeks after the completion of therapy. RESULTS: The primary end point was met in 59% of patients in the TID16W group, 59% of patients in the TID28W group, 52% of patients in the TID40W group, 69% of patients in the BID28W group, and 39% of patients in the TID28W-NR group. The sustained virologic response 12 weeks after the completion of therapy did not differ significantly according to treatment duration or dosage among ribavirin-containing regimens. This response was significantly higher with TID28W than with TID28W-NR (P=0.03). Rates of a sustained virologic response 12 weeks after the completion of therapy were 56 to 85% among patients with genotype 1b infection versus 11 to 47% among patients with genotype 1a infection and 58 to 84% among patients with IL28B CC versus 33 to 64% with non-CC genotypes. Rash, photosensitivity, nausea, vomiting, and diarrhea were the most common adverse events. CONCLUSIONS: The rate of a sustained virologic response 12 weeks after the completion of therapy was 52 to 69% among patients who received interferon-free treatment with faldaprevir in combination with deleobuvir plus ribavirin. (Funded by Boehringer Ingelheim; SOUND-C2 ClinicalTrials.gov number, NCT01132313.).

STARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection

“…In addition to the results presented here, faldaprevir has shown efficacy as part of an interferon-based regimen for treatment-experienced patients (STARTVerso3) [33], and as part of an interferon-free regimen [34]. Regional differences in the cost of HCV therapies may lead to continued use of interferon-based regimens for the foreseeable future.…”

Comparison of improved prognosis between hepatitis B‐ and hepatitis C‐related hepatocellular carcinoma

“…Safer and more effective HCV regimens may improve the prognosis of C-HCC. [34][35][36] A previous study also revealed the improved prognosis of B-HCC over time. However, that study included patients treated with surgery, ablation therapies and TACE.…”

Interleukin-28B Polymorphism is a Pharmacogenetic Predictor during Sofosbuvir Plus Pegylated Interferon and Ribavirin Therapy for Chronic Hepatitis C Egyptian Patients

“…These results indicated that CC genotype was associated with SVR. In that way, Zeuzem et al [51] recorded that the CC variant of rs12979860 was associated with increased likelihood of achieving SVR in comparison with non-CC variants. Consequently, the CC variant of SNP rs12979860 is the strongest genetic pretreatment predictor of SVR in HCV-G1 and G4 patients [21,28] …”