Vaniprevir with peginterferon alfa-2a and ribavirin in treatment-naive patients with chronic hepatitis C - a randomized phase 2 study
Hepatology,  Clinical Article

Manns MP et al. – Vaniprevir is a potent hepatitis C virus (HCV) protease inhibitor with a predictable resistance profile and favorable safety profile that is suitable for once– or twice–daily administration.

Methods
  • In this double-blind, placebo-controlled, dose-ranging study, treatment-naive patients with HCV genotype 1 infection (n = 94) were randomized to receive open-label PEG-IFN alfa-2a (180 µg/week) and ribavirin (1,000-1,200 mg/day) in combination with blinded placebo or vaniprevir (300 mg bid, 600 mg bid, 600 mg qd, or 800 mg qd) for 28 days, and then open-label PEG-IFN alfa-2a and ribavirin for an additional 44 weeks.
  • The primary efficacy end point was rapid viral response (RVR), defined as undetectable plasma HCV RNA at week 4.
  • Across all doses, vaniprevir was associated with a rapid 2-phase decline in viral load, with HCV RNA levels approximately 3 log10 IU/mL lower in vaniprevir-treated patients compared with placebo recipients.

Results
  • Across all doses, vaniprevir was associated with a rapid 2-phase decline in viral load, with HCV RNA levels approximately 3 log10 IU/mL lower in vaniprevir-treated patients compared with placebo recipients.
  • There were numerically higher, but not statistically significant, early and sustained virologic response rates with vaniprevir as compared with placebo.
  • Resistance profile was predictable with variants at R155 and D168 detected in a small number of patients.
  • No relationship between IL28B genotype and treatment outcomes was demonstrated in this study.
  • The incidence of adverse events was generally comparable between vaniprevir and placebo recipients; however, vomiting appeared to be more common at higher vaniprevir doses.

Please login or register to follow this author.
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Physician Assistant

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Physician Assistant Articles

1 Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): A randomised, multicentre, open-label, phase 3 non-inferiority trial The Lancet Oncology, October 22, 2014    Clinical Article

2 Dance for Parkinson's: A new framework for research on its physical, mental, emotional, and social benefits Complementary Therapies in Medicine, June 17, 2014    Review Article

3 Omega-3 supplements for patients in chemotherapy and/or radiotherapy: A systematic review Clinical Nutrition, November 21, 2014    Clinical Article

4 Global burden of cancer attributable to high body-mass index in 2012: A population-based study The Lancet Oncology, November 26, 2014    Clinical Article

5 Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents New England Journal of Medicine, November 18, 2014    Evidence Based Medicine    Clinical Article

6 Nonobstructive coronary artery disease and risk of myocardial infarction JAMA, November 6, 2014    Evidence Based Medicine    Clinical Article

7 Treatment of syphilis: a systematic review JAMA, November 13, 2014    Review Article    Clinical Article

8 Mechanical versus manual chest compression for out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised controlled trial The Lancet, November 26, 2014    Evidence Based Medicine    Clinical Article

9 Effects of salt substitutes on blood pressure: A meta-analysis of randomized controlled trials American Journal of Clinical Nutrition, October 31, 2014    Evidence Based Medicine    Review Article    Clinical Article

10 Bipolar disorder, affective psychosis, and schizophrenia in pregnancy and the post-partum period The Lancet, November 19, 2014    Evidence Based Medicine

11 Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial The Lancet, November 26, 2014    Clinical Article

12 Initial choice of oral glucose-lowering medication for diabetes mellitus: a patient-centered comparative effectiveness study JAMA Internal Medicine, November 14, 2014    Evidence Based Medicine    Clinical Article

13 Optimization of rituximab for the treatment of diffuse large B-cell lymphoma (II): extended rituximab exposure time in the smarte-R-CHOP-14 trial of the German High-grade Non-hodgkin Lymphoma Study Group Journal of Clinical Oncology, November 26, 2014    Clinical Article

14 Early versus on-demand nasoenteric tube feeding in acute pancreatitis New England Journal of Medicine, November 26, 2014    Evidence Based Medicine    Clinical Article

15 Ventriculitis caused by primary T-cell CNS lymphoma in an immunocompetent patient Journal of Clinical Oncology, November 26, 2014

16 Long-term safety and efficacy of factor IX gene therapy in hemophilia B New England Journal of Medicine, November 26, 2014    Evidence Based Medicine    Clinical Article

17 Management of high-grade gliomas in the elderly Seminars in Radiation Oncology, October 3, 2014    Clinical Article

18 The diagnosis and management of hiatus hernia BMJ, November 14, 2014    Evidence Based Medicine    Review Article    Clinical Article

19 Statins in the elderly: an answered question Current Opinion in Cardiology, June 9, 2014    Evidence Based Medicine    Review Article    Clinical Article

20 Changes in bone mineral density at 3 years in postmenopausal women receiving anastrozole and risedronate in the IBIS-II bone substudy: An international, double-blind, randomised, placebo-controlled trial The Lancet Oncology, November 26, 2014    Clinical Article

Indexed Journals in Physician Assistant: Advance for Physicians Assistants, American Family Physicianmore