Optimal follow-up time to determine the sustained virological response in patients with chronic hepatitis C receiving Peg-IFN and ribavirin

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1440-1746.2011.06802.x/abstract

Optimal follow-up time to determine the sustained virological response in

patients with chronic hepatitis C receiving Peg-IFN and ribavirin

Masashi Namikawa1,2,

Satoru Kakizaki1,*,

Yutaka Yata2,

Yuichi Yamazaki1,

Norio Horiguchi1,

Ken Sato1,

Hitoshi Takagi1,

Masatomo Mori1

DOI: 10.1111/j.1440-1746.2011.06802.x

© 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell

Publishing Asia Pty Ltd

Issue

Journal of Gastroenterology and Hepatology

Accepted Article (Accepted, unedited articles published online for future

issues)

Abstract

Background: This study evaluated whether the assessment of 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 PCR

HCV assay.

Methods and results: Two hundred 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 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 3 patients who relapsed after FW + 12 and all 3 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.

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1440-1746.2011.06802.x/abstract

Optimal follow-up time to determine the sustained virological response in

patients with chronic hepatitis C receiving Peg-IFN and ribavirin

Masashi Namikawa1,2,

Satoru Kakizaki1,*,

Yutaka Yata2,

Yuichi Yamazaki1,

Norio Horiguchi1,

Ken Sato1,

Hitoshi Takagi1,

Masatomo Mori1

DOI: 10.1111/j.1440-1746.2011.06802.x

© 2011 Journal of Gastroenterology and Hepatology Foundation and Blackwell

Publishing Asia Pty Ltd

Issue

Journal of Gastroenterology and Hepatology

Accepted Article (Accepted, unedited articles published online for future

issues)

Abstract

Background: This study evaluated whether the assessment of 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 PCR

HCV assay.

Methods and results: Two hundred 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 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 3 patients who relapsed after FW + 12 and all 3 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.