2 results on '"Godson Oguchi"'
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2. All‐oral 12‐week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY‐3 phase III study
- Author
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James N. Cooper, Ziad Younes, Reem Ghalib, Grisell Ortiz-Lasanta, Trevor Hawkins, Norman Gitlin, Jacob Lalezari, Fiona McPhee, David E. Bernstein, Paul J. Pockros, Delphine Hennicken, William Harlan, Eric Hughes, Khurram Rana, Natarajan Ravendhran, Paul J. Thuluvath, Eric Lawitz, Peter Varunok, David R. Nelson, Kris V. Kowdley, Mordechai Rabinovitz, B. Freilich, Aasim Sheikh, Godson Oguchi, and Michael J. Bennett
- Subjects
Adult ,Male ,Ledipasvir ,medicine.medical_specialty ,Pyrrolidines ,Time Factors ,Daclatasvir ,Genotype ,Sofosbuvir ,Voxilaprevir ,Administration, Oral ,Hepacivirus ,Antiviral Agents ,Gastroenterology ,Young Adult ,chemistry.chemical_compound ,Internal medicine ,medicine ,Humans ,Aged ,Hepatology ,business.industry ,Ribavirin ,Imidazoles ,Valine ,Hepatitis C ,Hepatitis C, Chronic ,Middle Aged ,medicine.disease ,Regimen ,chemistry ,Immunology ,Drug Therapy, Combination ,Female ,Carbamates ,Uridine Monophosphate ,business ,Rapid Communication ,medicine.drug - Abstract
Chronic infection with hepatitis C virus (HCV) genotype 3 is common throughout the world and remains a significant disease burden for many patients.1,2 Infection with HCV genotype 3 has been associated with an increased risk of progression to cirrhosis, as well as development of steatosis or hepatocellular carcinoma (HCC), compared with other HCV genotypes.3–5 In an observational cohort study, analysis of real-world data from the Veterans Affairs HCV clinical registry found that the risks of cirrhosis, HCC, liver-related hospitalization, and death were significantly higher in genotype 3–infected patients, compared with genotype 1–infected patients,6 underscoring the medical need for safe, effective treatment options for patients with genotype 3 infection. Recent advances have led to the approval of interferon (IFN)-free and/or ribavirin (RBV)-free therapies for chronic infection with HCV genotypes 1, 2, 3, and 4. However, for both treatment-naive and treatment-experienced patients with genotype 3 infection, IFN- and RBV-free therapy options are currently limited. Therapies approved in the United States and Europe for treatment of genotype 3 infection include a 24-week, all-oral regimen of sofosbuvir (SOF; a pangenotypic nonstructural protein [NS]5B inhibitor) in combination with RBV7,8 and a 24-week regimen of pegylated IFN (Peg-IFN) plus RBV.9,10 In addition, a 12-week, IFN-based regimen of SOF plus Peg-IFN and RBV8 is approved in Europe for treating genotype 3 infection, as are all-oral, 24-week regimens of daclatasvir (DCV; a potent, pangenotypic NS5A inhibitor) plus SOF with RBV11 and ledipasvir (LDV; an NS5A inhibitor) plus SOF with RBV12 for patients with compensated cirrhosis and/or previous treatment experience. The all-oral combination of SOF plus RBV requires 24 weeks of treatment because 12- and 16-week treatment durations were associated with lower response rates (30%-61% and 62%, respectively) in genotype 3–infected patients.7,13,14 With 24-week treatment, lower response rates were observed in genotype 3–infected patients who were treatment experienced (77%), particularly those with cirrhosis (60%), compared with those who were treatment naive (93%).7,15 In addition, there was an increased incidence of anemia, which is consistent with the hemolytic anemia known to occur with RBV treatment.15,16 Thus, patients with genotype 3 infection have a need for improved treatment options, preferably with therapies of shorter duration and without the addition of Peg-IFN or RBV. DCV was evaluated in combination with SOF in a phase II study.17 Treatment for 24 weeks with DCV plus SOF, with or without the addition of RBV, resulted in an 89% rate of sustained virological response (SVR) at post-treatment week 12 (SVR12) among 18 treatment-naive patients with genotype 3 infection.11,17 Of 5 genotype 3–infected patients who had ≥F3 fibrosis (based on FibroTest scores), all 5 achieved SVR12.11 In this phase III study, the efficacy and safety of 12-week, RBV-free treatment with DCV plus SOF were evaluated in treatment-naive and treatment-experienced patients chronically infected with HCV genotype 3.
- Published
- 2015
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