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A randomized trial of 48 versus 24 weeks of combination pegylated interferon and ribavirin therapy in genotype 6 chronic hepatitis C.
J Hepatol. 2012 May; 56(5):1012-8.JH

Abstract

BACKGROUND & AIMS

Genotype 6 chronic hepatitis C (HCV) is encountered predominantly in Southeast Asia and data on optimal treatment strategy is limited. This study was aimed at assessing the rate and predictors of sustained virological response (SVR) in genotype 6 chronic HCV following 48 and 24 weeks of pegylated interferon and ribavirin therapy.

METHODS

This investigator-initiated, open-label randomized trial was conducted in Vietnam between 2008 and 2010. One hundred and five treatment-naïve HCV genotype 6 patients were randomized to either 48-week (N=70) or 24-week (N=35) duration of pegylated interferon (PEG-IFN) alfa-2a 180 mcg/week and ribavirin (RBV) 15mg/kg/day; 92 patients completed the study (63 in the 48-week and 29 in the 24-week group, respectively). Primary outcome was sustained virological response (SVR) as intention-to-treat analysis.

RESULTS

There was no statistical difference in SVR between 48-week and 24-week treated groups (71% vs. 60%, respectively; p=0.24). In the 48-week and 24-week treatment groups, 81% and 80% of cases achieved rapid virological response (RVR) (p=0.86), and 86% and 80% achieved complete early virological response (p=0.45). Among those patients with RVR, SVR was in 86% (48-weeks), and 75% (24-weeks) of cases, whereas following non-RVR, only 8% of cases had an SVR with 48-week treatment duration.

CONCLUSIONS

Overall, RVR was achieved in the majority of genotype 6 patients and, in those patients, similar and high rates of SVR were noted following 24-week and 48-week therapy. This observation, however, needs validation in a larger study to demonstrate non-inferiority of the shorter duration therapy. In non-RVR patients, even 48-week therapy achieved low SVR rates.

Authors+Show Affiliations

Medic Medical Center, Ho Chi Minh City, Viet Nam.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

22266603

Citation

Thu Thuy, Pham Thi, et al. "A Randomized Trial of 48 Versus 24 Weeks of Combination Pegylated Interferon and Ribavirin Therapy in Genotype 6 Chronic Hepatitis C." Journal of Hepatology, vol. 56, no. 5, 2012, pp. 1012-8.
Thu Thuy PT, Bunchorntavakul C, Tan Dat H, et al. A randomized trial of 48 versus 24 weeks of combination pegylated interferon and ribavirin therapy in genotype 6 chronic hepatitis C. J Hepatol. 2012;56(5):1012-8.
Thu Thuy, P. T., Bunchorntavakul, C., Tan Dat, H., & Rajender Reddy, K. (2012). A randomized trial of 48 versus 24 weeks of combination pegylated interferon and ribavirin therapy in genotype 6 chronic hepatitis C. Journal of Hepatology, 56(5), 1012-8. https://doi.org/10.1016/j.jhep.2011.12.020
Thu Thuy PT, et al. A Randomized Trial of 48 Versus 24 Weeks of Combination Pegylated Interferon and Ribavirin Therapy in Genotype 6 Chronic Hepatitis C. J Hepatol. 2012;56(5):1012-8. PubMed PMID: 22266603.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized trial of 48 versus 24 weeks of combination pegylated interferon and ribavirin therapy in genotype 6 chronic hepatitis C. AU - Thu Thuy,Pham Thi, AU - Bunchorntavakul,Chalermrat, AU - Tan Dat,Ho, AU - Rajender Reddy,K, Y1 - 2012/01/17/ PY - 2011/08/24/received PY - 2011/10/28/revised PY - 2011/12/14/accepted PY - 2012/1/24/entrez PY - 2012/1/24/pubmed PY - 2012/10/24/medline SP - 1012 EP - 8 JF - Journal of hepatology JO - J. Hepatol. VL - 56 IS - 5 N2 - BACKGROUND & AIMS: Genotype 6 chronic hepatitis C (HCV) is encountered predominantly in Southeast Asia and data on optimal treatment strategy is limited. This study was aimed at assessing the rate and predictors of sustained virological response (SVR) in genotype 6 chronic HCV following 48 and 24 weeks of pegylated interferon and ribavirin therapy. METHODS: This investigator-initiated, open-label randomized trial was conducted in Vietnam between 2008 and 2010. One hundred and five treatment-naïve HCV genotype 6 patients were randomized to either 48-week (N=70) or 24-week (N=35) duration of pegylated interferon (PEG-IFN) alfa-2a 180 mcg/week and ribavirin (RBV) 15mg/kg/day; 92 patients completed the study (63 in the 48-week and 29 in the 24-week group, respectively). Primary outcome was sustained virological response (SVR) as intention-to-treat analysis. RESULTS: There was no statistical difference in SVR between 48-week and 24-week treated groups (71% vs. 60%, respectively; p=0.24). In the 48-week and 24-week treatment groups, 81% and 80% of cases achieved rapid virological response (RVR) (p=0.86), and 86% and 80% achieved complete early virological response (p=0.45). Among those patients with RVR, SVR was in 86% (48-weeks), and 75% (24-weeks) of cases, whereas following non-RVR, only 8% of cases had an SVR with 48-week treatment duration. CONCLUSIONS: Overall, RVR was achieved in the majority of genotype 6 patients and, in those patients, similar and high rates of SVR were noted following 24-week and 48-week therapy. This observation, however, needs validation in a larger study to demonstrate non-inferiority of the shorter duration therapy. In non-RVR patients, even 48-week therapy achieved low SVR rates. SN - 1600-0641 UR - https://www.unboundmedicine.com/medline/citation/22266603/A_randomized_trial_of_48_versus_24_weeks_of_combination_pegylated_interferon_and_ribavirin_therapy_in_genotype_6_chronic_hepatitis_C_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-8278(12)00060-8 DB - PRIME DP - Unbound Medicine ER -