Effectiveness of Extending Treatment Duration in Therapy with Pegylated Interferon and Ribavirin for Genotype 2 Hepatitis C Virus Infection.

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1 Effectiveness of Extending Treatment Duration in Therapy with Pegylated Interferon and Ribavirin for Genotype 2 Hepatitis C Virus Infection a a* b c d e a a f a a f b c d e

3 Enrollment N 36 RVR N 14 Standard therapy N 122 Extended therapy N 18 non RVR N 166 non RVR A N 115 Standard therapy N 82 non RVR B N 51 Extended therapy N 33 Standard therapy N 35 Extended therapy N Week of treatment Patient treatment flow diagram. The treatment duration was extended in IFN experienced patients or treatment naïve patients without RVR. Patient characteristics Factors All (n 36) Standard (n 239) Extended (n 67) P Gender (male female) Age (years) Body weight (kg) Previous interferon (yes no) ALT (IU L) GT (IU L) White blood cell count ( µl) 5,184 1,516 5,269 1,459 4,881 1,6.24 Hemoglobin (g dl) Platelet count (1, µl) Creatinine (IU L) Therapeutic outcomes (SVR Relapse) ALT, alanine aminotransferase; GT, glutamyl transpeptidase; SVR, sustained virological response.

4 Logistic regression analysis of the factors associated with detectable HCV RNA at week 4 of treatment Univariate Multivariate Factors Odds (range ) p Odds (range ) p Gender (male 1).76 ( ).24 Age (years) 1.2 ( ) ( ).51 Body weight (kg).98 ( ).14 Previous Interferon (yes 1) 1.4 ( ).15 ALT (1: 42 IU L) 1.5 ( ).15 GT (1: 4 IU L) 1.1 ( ).91 White blood cell count (1: 3,5 μl).57 ( ).14 Hemoglobin (1: 13.5 g dl).6 (.37.94).27 Platelet count (1: 15, μl).69 ( ).13 Creatinine (1:. IU L) 1.3 ( ).29 95% confidence interval; ALT, alanine aminotransferase; GT, glutamyl transpeptidase. Logistic regression analysis of the factors associated with detectable HCV RNA at week 8 of treatment Univariate Factors Odds (range ) p Gender (male 1).92 (.5 1.7). Age (years) 1.1 ( ).12 Body weight (kg).99 ( ).38 Previous Interferon (yes 1) 1.2 ( ).5 ALT (1: 42 IU L) 1.3 ( ).37 GT (1: 4 IU L) 1.1 ( ).88 White blood cell count (1: 3,5 μl).89 ( ).82 Hemoglobin (1: 13.5 g dl).96 ( ).89 Platelet count (1: 15, μl).77 ( ).43 Creatinine (1:. IU L) 1.5 ( ).24 95% confidence interval; ALT, alanine aminotransferase; GT, glutamyl transpeptidase.

5 A B Associations of virological response and drug adherence with SVR. A shows the rates of SVR with standard therapy and extended therapy for patient groups classified by different virological responses during treatment. B expresses the quintiles and medians of drug adherence to PegIFN and RBV regimens from to 24 weeks of treatment in the standard and the extended therapy.

6 Sustained virological response classified by previous therapy Previous therapy Total (% SVR) Standard (% SVR) Extended (% SVR) P Naïve (81%) (83%) (71%).24 Experienced (74%) (73%) (74%) 1. PegIFN RBV (69%) (69%) 29 (69%) 1. SVR, sustained virological response; PegIFN, pegylated interferon; RBV, ribavirin.

7 A 6 4 B -RVR-A C Comparisons of SVR rates between therapies with standard and extended durations classified by virological response and drug adherence during the treatment. The figures show the SVR rates with standard therapy (black bar) and extended therapy (open bar) in patient groups of RVR (A), non RVR A (B), and non RVR B (C). The figures also show the SVR rates in patient groups with good ( %) or insufficient ( %) adherence to PegIFN and RBV.

8 Kato N: Molecular virology of hepatitis C virus. Acta Med Okayama (1) 55: Poynard T, Bedossa P and Opolon P: Natural history of liver fibro sis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet (1997) 349: Omata M, Nishiguchi S, Ueno Y, Mochizuki H, Izumi N, Ikeda F, Toyoda H, Yokosuka O, Nirei K, Genda T, Umemura T, Takehara T, Sakamoto N, Nishigaki Y, Nakane K, Toda N, Ide T, Yanase M, Hino K, Gao B, Garrison KL, Dvory Sobol H, Ishizaki A, Omote M, Brainard D, Knox S, Symonds WT, McHutchison JG, Yatsuhashi H and Mizokami M: Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection:an open label, phase 3 trial. J Viral Hepat (14) 21: Makuuchi M, Kokudo N and Arii S: Clinical practice guidelines for hepatocellular carcinoma the Japan society of hepatology 9 update: Hepatol Res (1) 4 Supple 1: Berg T, von Wagner M, Nasser S, Sarrazin C, Heintges T, Gerlach T, Buggisch P, Goeser T, Rasenack J, Pape GR, Schmidt WE, Kallinowski B, Klinker H, Spengler U, Martus P, Alshuth U and Zeuzem S: Extended treatment duration for hepati tis C virus type 1: comparing 48 versus 72 weeks of peginterferon alfa 2a plus ribavirin. Gastroenterology (6) 13: Pearlman BL, Ehleben C and Saifee S: Treatment extension to 72 weeks of peginterferon and ribavirin in hepatitis c genotype 1 infected slow responders. Hepatology (7) 46: Watanabe S, Enomoto N, Koike K, Izumi N, Takikawa H, Hashimoto E, Moriyasu F, Kumada H, Imawari M, PERFECT Study Group: Prolonged treatment with pegylated interferon alpha 2b plus ribavirin improves sustained virological response in chronic hepatitis C genotype 1 patients with late response in a clinical real life setting in Japan. Hepatol Res (1) 4: Chayama K, Hayes CN, Yoshioka K, Moriwaki H, Okanoue T, Sakisaka S, Takehara T, Oketani M, Toyota J, Izumi N, Hiasa Y, Matsumoto A, Nomura H, Seike M, Ueno Y, Yotsuyanagi H and Kumada H: Factors predictive of sustained virological response following 72 weeks of combination therapy for genotype 1b hepati tis C. J Gastroenterol (11) 46: Akuta N, Suzuki F, Seko Y, Kawamura Y, Sezaki H, Suzuki Y, Hosaka T, Kobayashi M, Kobayashi M, Saitoh S, Arase Y, Ikeda K and Kumada H: Association of IL28B genotype and viral response of hepatitis C virus genotype 2 to interferon plus ribavirin combina tion therapy. J Med Virol (12) 84: Mangia A: Individualizing treatment duration in hepatitis C virus genotype 2 3 infected patients. Liver Int (11) 31: Yamaguchi Y, Tamori A, Tanaka Y, Iwai S, Kobayashi S, Fujii H, Morikawa H, Hagihara A, Enomoto M and Kawada N: Response guided therapy for patients with chronic hepatitis who have high viral loads of hepatitis C virus genotype 2. Hepatol Res (12) 42: Shiffman M, Cheinquer H and Berg C: Extended treatment with pegylated interferon alfa ribavirin in patients with genotype 2 3 chronic hepatitis C who do not achieve a rapid virological response: final analysis of the randomised N CORE trial. Hepatol Int (14) 8: Editors of the drafting committee for hepatitis management guidelines: the Japan society of hepatology. Guidelines for the management of hepatitis C virus infection: first edition, May 12, the Japan society of hepatology. Hepatol Res (13) 43: 1 34.

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