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Open‐label study of faldaprevir plus peginterferon and ribavirin in hepatitis C virus genotype 1‐infected patients who failed placebo plus peginterferon and ribavirin
Copyright policy )Open‐label study of faldaprevir plus peginterferon and ribavirin in hepatitis C virus genotype 1‐infected patients who failed placebo plus peginterferon and ribavirin
SummaryFaldaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, was evaluated in HCV genotype 1‐infected patients who failed peginterferon and ribavirin (PegIFN/RBV) treatment during one of three prior faldaprevir trials. Patients who received placebo plus PegIFN/RBV and had virological failure during a prior trial were enrolled and treated in two cohorts: prior relapsers (n = 43) and prior nonresponders (null responders, partial responders and patients with breakthrough; n = 75). Both cohorts received faldaprevir 240 mg once daily plus PegIFN/RBV for 24 weeks. Prior relapsers with early treatment success (ETS; HCV RNA <25 IU/mL detectable or undetectable at week 4 and <25 IU/mL undetectable at week 8) stopped treatment at week 24. Others received PegIFN/RBV through week 48. The primary efficacy endpoint was sustained virological response (HCV RNA <25 IU/mL undetectable) 12 weeks post treatment (SVR12). More prior nonresponders than prior relapsers had baseline HCV RNA ≥800 000 IU/mL (80% vs 58%) and a non‐CC IL28B genotype (91% vs 70%). Rates of SVR12 (95% CI) were 95.3% (89.1, 100.0) among prior relapsers and 54.7% (43.4, 65.9) among prior nonresponders; corresponding ETS rates were 97.7% and 65.3%. Adverse events led to faldaprevir discontinuations in 3% of patients. The most common Division of AIDS Grade ≥2 adverse events were anaemia (13%), nausea (10%) and hyperbilirubinaemia (9%). In conclusion, faldaprevir plus PegIFN/RBV achieved clinically meaningful SVR12 rates in patients who failed PegIFN/RBV in a prior trial, with response rates higher among prior relapsers than among prior nonresponders. The adverse event profile was consistent with the known safety profile of faldaprevir.
- Wellcome Trust United Kingdom
- Hospital Universitario La Paz Spain
- St George’s University Hospitals NHS Foundation Trust United Kingdom
- University of Vienna Austria
- Boehringer Ingelheim (Germany) Germany
Microsoft Academic Graph classification: medicine.medical_specialty Nausea Hepatitis C virus medicine.disease_cause Placebo Gastroenterology chemistry.chemical_compound Open label study Hepatitis C virus genotype Internal medicine medicine Adverse effect business.industry Ribavirin Virology chemistry Faldaprevir medicine.symptom business
Adult, Male, Aminoisobutyric Acids, Genotype, Proline, Hepacivirus, Antiviral Agents, Placebos, Leucine, Virology, Ribavirin, Humans, Aged, Salvage Therapy, Hepatology, Interferon-alpha, Hepatitis C, Chronic, Middle Aged, Thiazoles, Treatment Outcome, Infectious Diseases, Quinolines, Female, Oligopeptides
Adult, Male, Aminoisobutyric Acids, Genotype, Proline, Hepacivirus, Antiviral Agents, Placebos, Leucine, Virology, Ribavirin, Humans, Aged, Salvage Therapy, Hepatology, Interferon-alpha, Hepatitis C, Chronic, Middle Aged, Thiazoles, Treatment Outcome, Infectious Diseases, Quinolines, Female, Oligopeptides
Microsoft Academic Graph classification: medicine.medical_specialty Nausea Hepatitis C virus medicine.disease_cause Placebo Gastroenterology chemistry.chemical_compound Open label study Hepatitis C virus genotype Internal medicine medicine Adverse effect business.industry Ribavirin Virology chemistry Faldaprevir medicine.symptom business
citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).0 popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.Average influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).Average impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.Average citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).0 popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.Average influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).Average impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.Average
Citations provided by BIP!Popularity provided by BIP!- Wellcome Trust United Kingdom
- Hospital Universitario La Paz Spain
- St George’s University Hospitals NHS Foundation Trust United Kingdom
- University of Vienna Austria
- Boehringer Ingelheim (Germany) Germany
- Lomonosov Moscow State University Russian Federation
- Sechenov University Russian Federation
- St George's Hospital United Kingdom
- Queen Mary University of London United Kingdom
- University of British Columbia Canada
- Université Paris Diderot France
- University of Bern Switzerland
SummaryFaldaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, was evaluated in HCV genotype 1‐infected patients who failed peginterferon and ribavirin (PegIFN/RBV) treatment during one of three prior faldaprevir trials. Patients who received placebo plus PegIFN/RBV and had virological failure during a prior trial were enrolled and treated in two cohorts: prior relapsers (n = 43) and prior nonresponders (null responders, partial responders and patients with breakthrough; n = 75). Both cohorts received faldaprevir 240 mg once daily plus PegIFN/RBV for 24 weeks. Prior relapsers with early treatment success (ETS; HCV RNA <25 IU/mL detectable or undetectable at week 4 and <25 IU/mL undetectable at week 8) stopped treatment at week 24. Others received PegIFN/RBV through week 48. The primary efficacy endpoint was sustained virological response (HCV RNA <25 IU/mL undetectable) 12 weeks post treatment (SVR12). More prior nonresponders than prior relapsers had baseline HCV RNA ≥800 000 IU/mL (80% vs 58%) and a non‐CC IL28B genotype (91% vs 70%). Rates of SVR12 (95% CI) were 95.3% (89.1, 100.0) among prior relapsers and 54.7% (43.4, 65.9) among prior nonresponders; corresponding ETS rates were 97.7% and 65.3%. Adverse events led to faldaprevir discontinuations in 3% of patients. The most common Division of AIDS Grade ≥2 adverse events were anaemia (13%), nausea (10%) and hyperbilirubinaemia (9%). In conclusion, faldaprevir plus PegIFN/RBV achieved clinically meaningful SVR12 rates in patients who failed PegIFN/RBV in a prior trial, with response rates higher among prior relapsers than among prior nonresponders. The adverse event profile was consistent with the known safety profile of faldaprevir.