Quantification of hepatitis C virus in patients treated with peginterferon‐alfa 2a plus ribavirin treatment by COBAS TaqMan HCV test

Abstract

Extremely low levels of serum hepatitis C virus (HCV) RNA can be detected by COBAS TaqMan HCV test. To investigate whether the COBAS TaqMan HCV test is useful for measuring rapid virological response (RVR) and early virological response (EVR) to predict sustained virological response (SVR), we compared the virological response to PEG-IFN-alfa 2a plus RBV in 76 patients infected with HCV genotype 1 when undetectable HCV RNA by the COBAS TaqMan HCV test was used, with those when below 1.7 log IU/mL HCV RNA by COBAS TaqMan HCV test was used, which corresponded to the use of traditional methods. Among the 76 patients, 28 (36.8%) had SVR, 13 (17.1%) relapsed, 19 (25.0%) did not respond, and 16 (21.0%) discontinued the treatment due to side effects. The positive predictive values for SVR based on undetectable HCV RNA by COBAS TaqMan HCV test at 24 weeks after the end of treatment [10/10 (100%) at week 4, 21/23 (91.3%) at week 8 and 26/33 (78.7%) at week 12] were superior to those based on <1.7 log IU/mL HCV RNA [17/19 (89.4%) at week 4, 27/38 (71.0%) at week 8, and 27/43 (62.7%) at week 12]. The negative predictive values for SVR based on <1.7 log IU/mL HCV RNA by COBAS TaqMan HCV test [46/57 (80.7%) at week 4, 37/38 (97.3%) at week 8, and 32/33 (96.9%) at week 12] were superior to those based on undetectable HCV RNA [48/66 (72.7%) at week 4, 46/53 (86.7%) at week 8, and 41/43 (95.3%) at week 12]. The utilization of both undetectable RNA and <1.7 log IU/mL HCV RNA by COBAS TaqMan HCV test is useful and could predict SVR and non-SVR patients with greater accuracy.

Response to Peginterferon-alfa 2b and Ribavirin in Japanese Patients with Chronic Hepatitis C Genotype 2

“…The study protocol was approved the Ethics Committee of Chiba University School of Medicine and conformed to the ethical guidelines of the 1975 Declaration of Helsinki. In this study, 1.5 lg/kg of PEG-IFN-alfa 2b per week plus daily RBV (600 mg for 147 Genotype 2 patients were included in this study 7 [10,11]. HCV serotype was examined with serological genotyping assay [12].…”

“…Patients were eligible if they met the following inclusion criteria: (1) infected with HCV genotype 2, (2) age C20 years, (3) diagnosed as chronic hepatitis C, (4) no pregnancy, (5) no severe heart disease, (6) no abnormal hemogrobinemia, (7) no chronic renal failure, (8) no mental disorders, (9) no severe hepatic failure, (10) no autoimmune disorders, (11) no drug allergy for IFN or for nucleos(t)ide analogues including ribavirin, (12) no current intravenous drug abuse, and (13) no HIV infection. Most of the patients were male (55%) with a mean age of 51 years.…”

Occurrence of Hepatocellular Carcinoma Was Not a Rare Event during and Immediately after Antiviral Treatment in Japanese HCV-Positive Patients

“…Some of these patients had already been included in a previous report [15]. Patients were eligible if they met the following criteria: (1) infected with HCV genotype 1 or 2, (2) age >20 years, (3) diagnosed as chronic hepatitis C, (4) negative for HBs antigen, (5) negative for human immunodeficiency viral test, (6) no high titers of autoantibodies, (7) no severe renal disease, (8) no severe heart disease, (9) no mental disorders, (10) no current intravenous drug abuse, and (11) no pregnancy.…”

“…Adverse reactions were noted by oral inquiry (patient interview), physical examinations and laboratory tests. HCV RNA was measured by COBAS TaqMan HCV test (Roche Diagnostics, Tokyo, Japan), with levels ranging from 1.2 to 7.8 log IU/ml [15]. Serum ALT measurement and other liver function tests were carried out by standard methods every 4 weeks before, during, and for at least 24 weeks after the end of the treatment.…”

“…The mean age of chronic hepatitis C patients treated with PEG-IFN plus RBV is higher in Japan than in the USA and Western countries [14,15]. Older age is one of the risk factors associated with HCC [16].…”