Refinement of stopping rules during treatment of hepatitis c-genotype 1 infection with boceprevir combined with peginterferon/ribavirin
Hepatology,  Clinical Article

Jacobson IM et al. – Although a stopping rule of detectable HCV–RNA at Week 12 would forfeit some SVR cases, Week–12 HCV–RNA levels ≥100 IU/mL almost universally predicted failure to achieve SVR in both treatment–naïve and treatment–experienced patients. In boceprevir recipients, the combination of stopping rules of HCV–RNA ≥100 IU/mL at Week 12 and detectable at Week 24 maximized early discontinuation of futile therapy while minimizing premature treatment discontinuation.

Methods
  • Exploratory post–hoc analyses using SPRINT–2 (treatment–naïve) and RESPOND–2 (prior treatment–experienced) were undertaken to determine if protocol–specified stopping rules (detectable HCV–RNA at Week 24 for SPRINT–2 and at Week 12 for RESPOND–2) could be refined and harmonized.

Results
  • In SPRINT–2, a Week–12 rule with a HCV RNA cut–off of ≥100 IU/mL would have discontinued therapy in 65 of 195 failures (sensitivity 33%) without sacrificing a single SVR out of 475 successes (specificity 100%).
  • Viral variants emerged after Week 12 in 36 (73%) of 49 evaluable patients who would have discontinued at Week 12 using a ≥100 IU/mL rule.
  • In RESPOND–2, 5 of 6 patients with Week–12 HCV–RNA levels between LLD (9.3 IU/mL) and LLQ (25 IU/mL) who continued therapy despite the protocol–stipulated futility rule achieved SVR; one additional patient with a Week–12 HCV–RNA level of 148 IU/mL also continued therapy, had undetectable HCV–RNA at Week 16, and attained SVR.

Please login or register to follow this author.
Are you sure you want to Unfollow this Author?
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Gastroenterology

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

Most Popular Gastroenterology Articles

1 Screening prior to biological therapy in Crohn's disease: Adherence to guidelines and prevalence of infections. Results from a multicentre retrospective study Digestive and Liver Diseases, August 4, 2014    Clinical Article

2 Colesevelam for the treatment of bile acid malabsorption-associated diarrhea in patients with Crohn's disease: A randomized, double-blind, placebo-controlled study Journal of Crohn's and Colitis, August 27, 2014    Clinical Article

3 Clinical utility and diagnostic accuracy of faecal calprotectin for IBD at first presentation to gastroenterology services in adults aged 16-50years Journal of Crohn's and Colitis, September 8, 2014    Clinical Article

4 Fibrosis stage is the strongest predictor for disease-specific mortality in NAFLD after up to 33 years of follow-up Hepatology, August 22, 2014    Clinical Article

5 Risk of lymphoma in patients with inflammatory bowel disease treated with azathioprine and 6-mercaptopurine: a meta-analysis Clinical Gastroenterology and Hepatology , September 25, 2014    Clinical Article

6 Thiopurines and risk of colorectal neoplasia in patients with inflammatory bowel disease: A meta-analysis Clinical Gastroenterology and Hepatology , September 26, 2014    Evidence Based Medicine

7 Exclusive enteral nutritional therapy can relieve inflammatory bowel stricture in Crohn’s disease Journal of Clinical Gastroenterology, September 17, 2014    Clinical Article

8 Fecal lactoferrin in discriminating inflammatory bowel disease from irritable bowel syndrome: A diagnostic meta-analysis Full Text BMC Gastroenterology, July 14, 2014    Free full text    Evidence Based Medicine

9 Calcium intake and colorectal adenoma risk: Dose-response meta-analysis of prospective observational studies International Journal of Cancer, August 29, 2014    Evidence Based Medicine

10 Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: data from ultra 1, 2, and 3 The American Journal of Gastroenterology, September 10, 2014    Clinical Article

11 Risk of lymphoma in patients with inflammatory bowel disease treated with azathioprine and 6-mercaptopurine: a meta-analysis Clinical Gastroenterology and Hepatology , June 25, 2014    Evidence Based Medicine    Clinical Article

12 Long-term therapeutic effect of maintenance enteral nutrition for Crohn's disease Pediatrics International, September 16, 2014    Clinical Article

13 Antibiotics associated with increased risk of new-onset Crohn’s disease but not ulcerative colitis: A meta-analysis The American Journal of Gastroenterology, September 24, 2014    Evidence Based Medicine

14 A prospective, randomized, controlled, exploratory study of comprehensive dietary advice in ulcerative colitis: impact on disease activity and quality of life European Journal of Gastroenterology & Hepatology, July 10, 2014    Clinical Article

15 Placebo response rate in clinical trials of fistulizing Crohn’s disease: Systematic review and meta-analysis Clinical Gastroenterology and Hepatology , September 22, 2014    Evidence Based Medicine    Review Article

16 Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7-year results from the PRECiSE 3 study Alimentary Pharmacology and Therapeutics, September 5, 2014    Clinical Article

17 Long intestinal tube splinting really prevent recurrence of postoperative adhesive small bowel obstruction? A study of 1071 cases The American Journal of Surgery, July 23, 2014    Clinical Article

18 Adalimumab dose escalation is effective for managing secondary loss of response in Crohn's disease Alimentary Pharmacology and Therapeutics, September 11, 2014    Clinical Article

19 The management of Crohn's disease and ulcerative colitis during pregnancy and lactation Alimentary Pharmacology and Therapeutics, September 12, 2014    Review Article

20 Plasma 25-hydroxyvitamin D and risk of colorectal cancer after adjusting for inflammatory markers Cancer Epidemiology, Biomarkers & Prevention, August 15, 2014    Clinical Article

Indexed Journals in Gastroenterology: Gastroenterology, American Journal of Gastroenterology, Gutmore

Register now to view all the MDLinx contents (FREE)!

  • Stay current on the latest literature, research and clinical news
  • Get special communications and offers from MDLinx and our sponsors
  • Receive invitations to paid market research
View Samples and Register

Connect with us, stay current.

Receive the latest mecial news
updates for free via email

Sign up!

Subscribe to our free RSS feeds:

Get the latest news in your specialty automatically added to your newsreader or your personal My Yahoo!, Google, My MSN or My AOL page. Learn More

Close