BACKGROUND & AIMS: Due to the possible teratogenic effect of ribavirin, effective contraception is mandatory during antiviral therapy in patients with chronic hepatitis C (CHC). The aim of this study was to evaluate seminal parameters and ribavirin and HCV-RNA concentrations in seminal fluid and serum prior to and during antiviral treatment. PATIENTS AND METHODS: Fifteen male patients (age: 42+/-9 (years+/-SD)) with CHC treated with pegylated interferon-alpha-2a and ribavirin were investigated. Seminal fluid (sperm concentration, motility, and morphology) was analysed morphologically. HCV-RNA and ribavirin concentration were determined by quantitative PCR and HPLC, respectively. Examinations were carried out at baseline, week 4, and week 12. RESULTS: Ribavirin concentration was higher in seminal fluid than in serum (week 4: 5.2+/-2.5 vs. 2.1+/-0.3; week 12: 4.4+/-1.8 vs. 2.0+/-0.3 (microg/ml, mean+/-SD; p<0.001)). Semen abnormalities were common at baseline (asthenoteratozoospermia: n=6; asthenozoospermia: n=3; teratozoospermia: n=3). Sperm density (BL: 67+/-33x10(6)/ml; week 4: 42+/-25 (p<0.05); week 12: 49+/-33 (n.s.)), percentage of sperm with progressive motility (BL: 40+/-26%; week 4: 27+/-25; week 12: 31+/-20 (n.s.)), and percentage of sperm with normal morphology (BL: 25+/-15; week 4: 20+/-11; week 12: 16+/-9; p<0.05 for both) further decreased during antiviral therapy. HCV-RNA was detectable in the seminal fluid of only two patients prior to antiviral therapy and was undetectable in all patients during combination therapy. CONCLUSION: Semen abnormalities were common in CHC patients, with further impairment during antiviral therapy. Ribavirin concentration was elevated twofold in seminal fluid compared to serum levels, which reinforces the need for contraception during antiviral combination therapy. Copyright 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
BACKGROUND & AIMS: Due to the possible teratogenic effect of ribavirin, effective contraception is mandatory during antiviral therapy in patients with chronic hepatitis C (CHC). The aim of this study was to evaluate seminal parameters and ribavirin and HCV-RNA concentrations in seminal fluid and serum prior to and during antiviral treatment. PATIENTS AND METHODS: Fifteen male patients (age: 42+/-9 (years+/-SD)) with CHC treated with pegylated interferon-alpha-2a and ribavirin were investigated. Seminal fluid (sperm concentration, motility, and morphology) was analysed morphologically. HCV-RNA and ribavirin concentration were determined by quantitative PCR and HPLC, respectively. Examinations were carried out at baseline, week 4, and week 12. RESULTS:Ribavirin concentration was higher in seminal fluid than in serum (week 4: 5.2+/-2.5 vs. 2.1+/-0.3; week 12: 4.4+/-1.8 vs. 2.0+/-0.3 (microg/ml, mean+/-SD; p<0.001)). Semen abnormalities were common at baseline (asthenoteratozoospermia: n=6; asthenozoospermia: n=3; teratozoospermia: n=3). Sperm density (BL: 67+/-33x10(6)/ml; week 4: 42+/-25 (p<0.05); week 12: 49+/-33 (n.s.)), percentage of sperm with progressive motility (BL: 40+/-26%; week 4: 27+/-25; week 12: 31+/-20 (n.s.)), and percentage of sperm with normal morphology (BL: 25+/-15; week 4: 20+/-11; week 12: 16+/-9; p<0.05 for both) further decreased during antiviral therapy. HCV-RNA was detectable in the seminal fluid of only two patients prior to antiviral therapy and was undetectable in all patients during combination therapy. CONCLUSION: Semen abnormalities were common in CHCpatients, with further impairment during antiviral therapy. Ribavirin concentration was elevated twofold in seminal fluid compared to serum levels, which reinforces the need for contraception during antiviral combination therapy. Copyright 2010 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
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