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Re-treatment of previous non-responders and relapsers to interferon plus ribavirin with peginterferon alfa-2a (40KD), ribavirin ± amantadine in patients with chronic hepatitis C: randomized multicentre clinical trial.
Ann Hepatol. 2012 Jan-Feb; 11(1):52-61.AH

Abstract

INTRODUCTION

A large number of patients with chronic hepatitis C have not been cured with interferon-based therapy. Therefore, we evaluated the efficacy of amantadine combined with the standard of care(pegylated interferon plus ribavirin) in patients who had not responded to or had relapsed after ≥ 24 weeks of treatment with conventional interferon plus ribavirin.

MATERIAL AND METHODS

Patients stratified by previous response (i.e., non-response or relapse) were randomized to 48 weeks of open-label treatment with peginterferon alfa-2a (40KD) 180 µg/week plus ribavirin 1,000/1,200 mg/day plus amantadine 200 mg/day (triple therapy), or the standard of care (peginterferon alfa-2a [40KD] plus ribavirin).

RESULTS

The primary outcome was sustained virological response (SVR), defined as undetectable hepatitis C virus RNA in serum (< 50 IU/mL) at end of follow-up (week 72). Among patients with a previous non-response, 12/53 (22.6%; 95% confidence interval [CI] 12.3-36.2%) randomized to triple therapy achieved an SVR compared with 16/52 (30.8%; 95% CI 18.7-45.1%) randomized to the standard of care. Among patients with a previous relapse 22/39 (56.4%; 95% CI 39.6-72.2%) randomized to triple therapy achieved an SVR compared with 23/38 (60.5%; 95% CI 43.4-76.0%) randomized to the standard of care. Undetectable HCV RNA (< 50 IU/mL) at week 12 had a high positive predictive value for SVR. A substantial proportion of non-responders and relapsers to conventional interferon plus ribavirin achieve an SVR when re-treated with peginterferon alfa-2a (40KD) plus ribavirin.

CONCLUSION

Amantadine does not enhance SVR rates in previously treated patients with chronic hepatitis C and cannot be recommended in this setting.

Authors+Show Affiliations

University of São Paulo School of Medicine and Instituto de Infectologia Emílio Ribas, São Paulo, Brazil. mgpessoa@usp.brNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22166561

Citation

Pessôa, Mario G., et al. "Re-treatment of Previous Non-responders and Relapsers to Interferon Plus Ribavirin With Peginterferon Alfa-2a (40KD), Ribavirin ± Amantadine in Patients With Chronic Hepatitis C: Randomized Multicentre Clinical Trial." Annals of Hepatology, vol. 11, no. 1, 2012, pp. 52-61.
Pessôa MG, Cheinquer H, Almeida PR, et al. Re-treatment of previous non-responders and relapsers to interferon plus ribavirin with peginterferon alfa-2a (40KD), ribavirin ± amantadine in patients with chronic hepatitis C: randomized multicentre clinical trial. Ann Hepatol. 2012;11(1):52-61.
Pessôa, M. G., Cheinquer, H., Almeida, P. R., Silva, G. F., Lima, M. P., Paraná, R., Lacerda, M. A., Parise, E. R., Pernambuco, J. R., Pedrosa, S. S., Teixeira, R., Sette, H., & Tatsch, F. (2012). Re-treatment of previous non-responders and relapsers to interferon plus ribavirin with peginterferon alfa-2a (40KD), ribavirin ± amantadine in patients with chronic hepatitis C: randomized multicentre clinical trial. Annals of Hepatology, 11(1), 52-61.
Pessôa MG, et al. Re-treatment of Previous Non-responders and Relapsers to Interferon Plus Ribavirin With Peginterferon Alfa-2a (40KD), Ribavirin ± Amantadine in Patients With Chronic Hepatitis C: Randomized Multicentre Clinical Trial. Ann Hepatol. 2012 Jan-Feb;11(1):52-61. PubMed PMID: 22166561.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Re-treatment of previous non-responders and relapsers to interferon plus ribavirin with peginterferon alfa-2a (40KD), ribavirin ± amantadine in patients with chronic hepatitis C: randomized multicentre clinical trial. AU - Pessôa,Mario G, AU - Cheinquer,Hugo, AU - Almeida,Paulo R L, AU - Silva,Giovanni F, AU - Lima,Maria Patelli J S, AU - Paraná,Raymundo, AU - Lacerda,Marco A, AU - Parise,Edison R, AU - Pernambuco,José R B, AU - Pedrosa,Suelene S, AU - Teixeira,Rosângela, AU - Sette,Hoel,Jr AU - Tatsch,Fernando, PY - 2011/12/15/entrez PY - 2011/12/15/pubmed PY - 2012/6/13/medline SP - 52 EP - 61 JF - Annals of hepatology JO - Ann Hepatol VL - 11 IS - 1 N2 - INTRODUCTION: A large number of patients with chronic hepatitis C have not been cured with interferon-based therapy. Therefore, we evaluated the efficacy of amantadine combined with the standard of care(pegylated interferon plus ribavirin) in patients who had not responded to or had relapsed after ≥ 24 weeks of treatment with conventional interferon plus ribavirin. MATERIAL AND METHODS: Patients stratified by previous response (i.e., non-response or relapse) were randomized to 48 weeks of open-label treatment with peginterferon alfa-2a (40KD) 180 µg/week plus ribavirin 1,000/1,200 mg/day plus amantadine 200 mg/day (triple therapy), or the standard of care (peginterferon alfa-2a [40KD] plus ribavirin). RESULTS: The primary outcome was sustained virological response (SVR), defined as undetectable hepatitis C virus RNA in serum (< 50 IU/mL) at end of follow-up (week 72). Among patients with a previous non-response, 12/53 (22.6%; 95% confidence interval [CI] 12.3-36.2%) randomized to triple therapy achieved an SVR compared with 16/52 (30.8%; 95% CI 18.7-45.1%) randomized to the standard of care. Among patients with a previous relapse 22/39 (56.4%; 95% CI 39.6-72.2%) randomized to triple therapy achieved an SVR compared with 23/38 (60.5%; 95% CI 43.4-76.0%) randomized to the standard of care. Undetectable HCV RNA (< 50 IU/mL) at week 12 had a high positive predictive value for SVR. A substantial proportion of non-responders and relapsers to conventional interferon plus ribavirin achieve an SVR when re-treated with peginterferon alfa-2a (40KD) plus ribavirin. CONCLUSION: Amantadine does not enhance SVR rates in previously treated patients with chronic hepatitis C and cannot be recommended in this setting. SN - 1665-2681 UR - https://www.unboundmedicine.com/medline/citation/22166561/Re_treatment_of_previous_non_responders_and_relapsers_to_interferon_plus_ribavirin_with_peginterferon_alfa_2a__40KD__ribavirin_±_amantadine_in_patients_with_chronic_hepatitis_C:_randomized_multicentre_clinical_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/968775 DB - PRIME DP - Unbound Medicine ER -