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Efficacy and safety of peginterferon α-2a (40 KD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe.
Eur J Gastroenterol Hepatol. 2011 Nov; 23(11):1004-10.EJ

Abstract

OBJECTIVE

Assess the safety and efficacy of 24 or 48 weeks of treatment with peginterferon α-2a (40 KD) plus ribavirin in treatment-naive patients with chronic hepatitis C.

METHODS

All patients in this open-label multinational study were assigned at the investigator's discretion to receive peginterferon α-2a (40 KD) 180 µg/week plus ribavirin (800 mg/day) for a total of 24 weeks or peginterferon α-2a (40 KD) 180 µg/week plus ribavirin (1000/1200 mg/day) for a total of 48 weeks. Treatment success was defined as sustained virological response [sustained virological response (SVR); hepatitis C virus RNA less than 50 IU/ml after completion of untreated follow-up].

RESULTS

A total of 789 treatment-naive patients were enrolled, of whom 91% (138 of 152) of nongenotype 1 patients and 77% (490 of 637) of genotype 1 patients completed 24 and 48 weeks of treatment, respectively. The overall SVR rate was 58% (459 of 789), and was 70 and 55% in nongenotype 1 and genotype 1 patients, respectively. Age (per 10-year decrement) and baseline hepatitis C virus RNA level (≤ 400 000 vs. >4 00 000 IU/ml) were significantly associated with SVR by multiple logistic regression analysis. The safety profile of peginterferon α-2a (40 KD) plus ribavirin was similar to that reported in pivotal trials, with no new or unexpected safety signals.

CONCLUSION

The combination of peginterferon α-2a (40 KD) plus ribavirin was well tolerated and produced an overall SVR rate of 58% in treatment-naive patients. This study confirms that SVR rates achieved in pivotal clinical trials in Western Europe and the USA can be achieved in routine clinical practice in Central and Eastern Europe.

Authors+Show Affiliations

Department of Internal Medicine, 1st Medical Faculty, Charles University Prague and Central Military hospital, Prague, Czech Republic. petr.urbanek@uvn.czNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Controlled Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

21904204

Citation

Urbanek, Petr, et al. "Efficacy and Safety of Peginterferon Α-2a (40 KD) Plus Ribavirin in Treatment-naive Chronic Hepatitis C Patients in Central and Eastern Europe." European Journal of Gastroenterology & Hepatology, vol. 23, no. 11, 2011, pp. 1004-10.
Urbanek P, Oltman M, Ivanovski L, et al. Efficacy and safety of peginterferon α-2a (40 KD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe. Eur J Gastroenterol Hepatol. 2011;23(11):1004-10.
Urbanek, P., Oltman, M., Ivanovski, L., Rehák, V., Messinger, D., Tietz, A., & Husa, P. (2011). Efficacy and safety of peginterferon α-2a (40 KD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe. European Journal of Gastroenterology & Hepatology, 23(11), 1004-10. https://doi.org/10.1097/MEG.0b013e32834b326b
Urbanek P, et al. Efficacy and Safety of Peginterferon Α-2a (40 KD) Plus Ribavirin in Treatment-naive Chronic Hepatitis C Patients in Central and Eastern Europe. Eur J Gastroenterol Hepatol. 2011;23(11):1004-10. PubMed PMID: 21904204.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of peginterferon α-2a (40 KD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe. AU - Urbanek,Petr, AU - Oltman,Marian, AU - Ivanovski,Ljubomir, AU - Rehák,Vratislav, AU - Messinger,Diethelm, AU - Tietz,Andreas, AU - Husa,Petr, PY - 2011/9/10/entrez PY - 2011/9/10/pubmed PY - 2012/2/1/medline SP - 1004 EP - 10 JF - European journal of gastroenterology & hepatology JO - Eur J Gastroenterol Hepatol VL - 23 IS - 11 N2 - OBJECTIVE: Assess the safety and efficacy of 24 or 48 weeks of treatment with peginterferon α-2a (40 KD) plus ribavirin in treatment-naive patients with chronic hepatitis C. METHODS: All patients in this open-label multinational study were assigned at the investigator's discretion to receive peginterferon α-2a (40 KD) 180 µg/week plus ribavirin (800 mg/day) for a total of 24 weeks or peginterferon α-2a (40 KD) 180 µg/week plus ribavirin (1000/1200 mg/day) for a total of 48 weeks. Treatment success was defined as sustained virological response [sustained virological response (SVR); hepatitis C virus RNA less than 50 IU/ml after completion of untreated follow-up]. RESULTS: A total of 789 treatment-naive patients were enrolled, of whom 91% (138 of 152) of nongenotype 1 patients and 77% (490 of 637) of genotype 1 patients completed 24 and 48 weeks of treatment, respectively. The overall SVR rate was 58% (459 of 789), and was 70 and 55% in nongenotype 1 and genotype 1 patients, respectively. Age (per 10-year decrement) and baseline hepatitis C virus RNA level (≤ 400 000 vs. >4 00 000 IU/ml) were significantly associated with SVR by multiple logistic regression analysis. The safety profile of peginterferon α-2a (40 KD) plus ribavirin was similar to that reported in pivotal trials, with no new or unexpected safety signals. CONCLUSION: The combination of peginterferon α-2a (40 KD) plus ribavirin was well tolerated and produced an overall SVR rate of 58% in treatment-naive patients. This study confirms that SVR rates achieved in pivotal clinical trials in Western Europe and the USA can be achieved in routine clinical practice in Central and Eastern Europe. SN - 1473-5687 UR - https://www.unboundmedicine.com/medline/citation/21904204/Efficacy_and_safety_of_peginterferon_α_2a__40_KD__plus_ribavirin_in_treatment_naive_chronic_hepatitis_C_patients_in_Central_and_Eastern_Europe_ L2 - http://dx.doi.org/10.1097/MEG.0b013e32834b326b DB - PRIME DP - Unbound Medicine ER -