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Optimal follow-up time to determine the sustained virological response in patients with chronic hepatitis C receiving pegylated-interferon and ribavirin.
J Gastroenterol Hepatol. 2012 Jan; 27(1):69-75.JG

Abstract

BACKGROUND AND AIM

This study evaluated whether the assessment of hepatitis C virus (HCV)-RNA at 12 weeks (FW+12) post-treatment follow-up was as applicable as FW+24 to evaluate sustained virological response (SVR) using the highly sensitive real-time polymerase chain reaction (PCR) HCV assay.

METHODS AND RESULTS

Two hundred and twenty-two patients with chronic hepatitis C were included in this study. Pegylated interferon (Peg-IFN) and ribavirin were administered for 24-72 weeks based on the genotype and viral load. Serum HCV-RNA was measured using real-time PCR at pretreatment, the end of treatment, FW+4, FW+8, FW+12, FW+16, FW+20 and FW+24. Two hundred patients had a virological response at the end of treatment. One hundred and forty-eight of 200 (74.0%) patients with a virological response at the end of treatment had an SVR at the FW+24. The positive predictive value (PPV) to identify patients with SVR at FW+4, FW+8, FW+12 was 87.1, 96.1, 98.0%, respectively. The viral load showed a reversion to the basal level as early as 8 weeks in relapse patients. There were only three patients who relapsed after FW+12 and all three of these patients were females with genotype Ib and a high viral load.

CONCLUSION

The assessment of serum HCV-RNA FW+12, using the highly sensitive real-time PCR assay, is almost as effective as FW+24 to predict SVR. However, there are false negatives in female patients with a high viral load of genotype Ib when the SVR is predicted by FW+12. The current standard with FW+24 is reasonable, but the assessment of serum HCV-RNA FW+12 may be effective in most patients.

Authors+Show Affiliations

Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.No 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

Language

eng

PubMed ID

21649727

Citation

Namikawa, Masashi, et al. "Optimal Follow-up Time to Determine the Sustained Virological Response in Patients With Chronic Hepatitis C Receiving Pegylated-interferon and Ribavirin." Journal of Gastroenterology and Hepatology, vol. 27, no. 1, 2012, pp. 69-75.
Namikawa M, Kakizaki S, Yata Y, et al. Optimal follow-up time to determine the sustained virological response in patients with chronic hepatitis C receiving pegylated-interferon and ribavirin. J Gastroenterol Hepatol. 2012;27(1):69-75.
Namikawa, M., Kakizaki, S., Yata, Y., Yamazaki, Y., Horiguchi, N., Sato, K., Takagi, H., & Mori, M. (2012). Optimal follow-up time to determine the sustained virological response in patients with chronic hepatitis C receiving pegylated-interferon and ribavirin. Journal of Gastroenterology and Hepatology, 27(1), 69-75. https://doi.org/10.1111/j.1440-1746.2011.06802.x
Namikawa M, et al. Optimal Follow-up Time to Determine the Sustained Virological Response in Patients With Chronic Hepatitis C Receiving Pegylated-interferon and Ribavirin. J Gastroenterol Hepatol. 2012;27(1):69-75. PubMed PMID: 21649727.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Optimal follow-up time to determine the sustained virological response in patients with chronic hepatitis C receiving pegylated-interferon and ribavirin. AU - Namikawa,Masashi, AU - Kakizaki,Satoru, AU - Yata,Yutaka, AU - Yamazaki,Yuichi, AU - Horiguchi,Norio, AU - Sato,Ken, AU - Takagi,Hitoshi, AU - Mori,Masatomo, PY - 2011/6/9/entrez PY - 2011/6/9/pubmed PY - 2012/5/12/medline SP - 69 EP - 75 JF - Journal of gastroenterology and hepatology JO - J. Gastroenterol. Hepatol. VL - 27 IS - 1 N2 - BACKGROUND AND AIM: This study evaluated whether the assessment of hepatitis C virus (HCV)-RNA at 12 weeks (FW+12) post-treatment follow-up was as applicable as FW+24 to evaluate sustained virological response (SVR) using the highly sensitive real-time polymerase chain reaction (PCR) HCV assay. METHODS AND RESULTS: Two hundred and twenty-two patients with chronic hepatitis C were included in this study. Pegylated interferon (Peg-IFN) and ribavirin were administered for 24-72 weeks based on the genotype and viral load. Serum HCV-RNA was measured using real-time PCR at pretreatment, the end of treatment, FW+4, FW+8, FW+12, FW+16, FW+20 and FW+24. Two hundred patients had a virological response at the end of treatment. One hundred and forty-eight of 200 (74.0%) patients with a virological response at the end of treatment had an SVR at the FW+24. The positive predictive value (PPV) to identify patients with SVR at FW+4, FW+8, FW+12 was 87.1, 96.1, 98.0%, respectively. The viral load showed a reversion to the basal level as early as 8 weeks in relapse patients. There were only three patients who relapsed after FW+12 and all three of these patients were females with genotype Ib and a high viral load. CONCLUSION: The assessment of serum HCV-RNA FW+12, using the highly sensitive real-time PCR assay, is almost as effective as FW+24 to predict SVR. However, there are false negatives in female patients with a high viral load of genotype Ib when the SVR is predicted by FW+12. The current standard with FW+24 is reasonable, but the assessment of serum HCV-RNA FW+12 may be effective in most patients. SN - 1440-1746 UR - https://www.unboundmedicine.com/medline/citation/21649727/Optimal_follow_up_time_to_determine_the_sustained_virological_response_in_patients_with_chronic_hepatitis_C_receiving_pegylated_interferon_and_ribavirin_ L2 - https://doi.org/10.1111/j.1440-1746.2011.06802.x DB - PRIME DP - Unbound Medicine ER -