Shortening of treatment duration in patients with chronic hepatitis C genotype 2 and 3 - impact of ribavirin dose - a randomized multicentre trial

BMC Research Notes

Peter Ferenci⁵  Michael Gschwantler²  Martin Bischof⁷  Gabriele Fischer⁴  Hermann Laferl³  Thomas-Matthias Scherzer⁵  Sigrid Metz-Gercek⁶  Andreas Maieron¹ 

[1] Gastroenterology & Hepatology, Elisabethinen Hospital, Fadingerstrasse 1, Linz, 4020, Austria;Internal Medicine 4, Wilhelminenhospital, Montleartstraße 37, Vienna, 1160, Austria;Internal Medicine 4, Sozialmedizinisches Zentrum Süd - Kaiser-Franz-Josef Hospital, Kundratstraße 3, Wien 1100, Austria;Department of Psychiatry and Psychotherapy, Medical University Vienna, Waehringer Guertel 18-20, Vienna 1090, Austria;Gastroenterology & Hepatology, Internal Medicine III, Medical University Vienna, Waehringergürtel 18 - 20, Vienna, 1090, Austria;Hygiene, Microbiology and Tropical Medicine, Elisabethinen Hospital, Fadingerstrasse 1, Linz, 4020, Austria;Internal Medicine 4, Hospital Rudolfstiftung, Juchgasse 25, Vienna, 1030, Austria

关键词: randomized controlled trial;    genotype 2 and 3;    Ribavirin dose;    treatment duration;    Hepatitis C;   

Others  :  1167420
DOI  :  10.1186/1756-0500-4-220

 received in 2011-05-18, accepted in 2011-06-29,  发布年份 2011

【 摘 要 】

Background

Chronic hepatitis C (CHC) Patients, infected with genotype (GT) 2 or 3 are treated with Peg-IFN and ribavirin (RBV) (800 mg/day) for 24 weeks. Treatment duration can be shortened to 12-16 weeks if a higher dose of RBV (1.000/1.200 mg/day) was used without considerable loss of responsiveness or increased risk of relapse. Previously we have shown that in patients with CHC, GT 2/3 RBV can be reduced to 400 mg/day if administered for 24 weeks without an increase in relapse rates. Therefore we investigated the efficacy of a reduced RBV dosage of 400 mg/day with shorter treatment duration (16 weeks).

Methods

Treatment naïve patients with CHC, GT 2/3 were randomized to receive 180 μg peginterferonα2a/week in combination with either 800 (group C) or 400 mg/d (group D) for 16 weeks. The primary endpoint was SVR.

Results

12 months after the first patient was randomized a inferior outcome of group D as compared to group C was noted, therefore the study was terminated. At study termination 89 patients were enrolled (group C: 31, D: 51). The SVR rate was statistically different in the two study groups with 51.6% in group C and 28.4% in group D (p = 0.038). Patients with low viral load had higher SVR rates (C: 67%, D: 33%) than those with high viral load (C: 33%, D: 21%).

Conclusion

Both treatment duration and the dose of RBV play a major role to optimize outcome of patients with GT3. If one intends to shorten the treatment weight based RBV dose should be used, if lower RBV doses are used patients should be treated for at least 24 weeks as. A treatment regimen with a reduced RBV dosage and shortened treatment duration is associated with low SVR rates due to high relapse rates.

Trial registration

NCT01258101

【 授权许可】

   
2011 Maieron et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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