AIM: To evaluate the impact of therapeutic education on adherence to antiviral treatment and sustained virological response (SVR) in a real-life setting in genotype 2/3 hepatitis C,as there are few adherence data in g...AIM: To evaluate the impact of therapeutic education on adherence to antiviral treatment and sustained virological response (SVR) in a real-life setting in genotype 2/3 hepatitis C,as there are few adherence data in genotype 2/3 infection,even from randomized trials.METHODS: This prospective survey included genotype 2/3 patients who received peg-interferon alfa-2b and ribavirin.There was no intervention.Adherence was self-reported over the past 4 wk (peg-interferon) or 7 d (ribavirin).Adherence to bitherapy was defined as adherence to the two drugs for ≥ 20 wk.SVR was defined as undetectable RNA ≥ 12 wk after the end of treatment.RESULTS: 370/674 patients received education during the first 3 mo of treatment.After 6 mo,adherence to bitherapy was higher in educated patients (61% vs 47%,P = 0.01).Adherence to peg-interferon was 78% vs 69% (P = 0.06).Adherence to ribavirin was 70% vs 56% (P = 0.006).The SVR (77% vs 70%,P = 0.05) and relapse (10% vs 16%,P = 0.09) rates tended to be improved.After adjustment for baseline differences,education improved adherence [Odds ratio (OR) 1.58,P = 0.04] but not the SVR (OR 1.54,P = 0.06).CONCLUSION: In genotype 2/3 patients,therapeutic education helped maintain real-life adherence to bitherapy.展开更多
We aim to determine the baseline factors associated with partial and cEVR by analyzing the data of 1861 Egyptian patients treated for 12 weeks with a course of Peg-IFN plus RBV. Base line data of 1861 Egyptian patient...We aim to determine the baseline factors associated with partial and cEVR by analyzing the data of 1861 Egyptian patients treated for 12 weeks with a course of Peg-IFN plus RBV. Base line data of 1861 Egyptian patients with chronic hepatitis C coming at Cairo-Fatemic Hospital for HCV treatment were studied including full clinical, Ultrasonographic examination, laboratory evaluation and liver biopsy. The most significant variables in relation to complete early virological response were low Hb level (13 gm/dl) with p 0.01, the stage of fibrosis p value < 0.05 and the grades of inflammation p value were associated with less achievement of c EVR. We conclude that identifying the most significant predictors of response such as Hb, stage of fibrosis F, at baseline before initiating treatment is mandatory to predict which patient will be more expected to achieve a cEVR and thus reducing the side-effects and healthcare costs associated with interferon therapies.展开更多
AIM: To evaluate the efficacy of amantadine plus interferonalpha and ribavirin in non-responder patients with chronic hepatitis C.METHODS: Twenty-six non-responder patients received the regimen of IFN-α-2a at a dose ...AIM: To evaluate the efficacy of amantadine plus interferonalpha and ribavirin in non-responder patients with chronic hepatitis C.METHODS: Twenty-six non-responder patients received the regimen of IFN-α-2a at a dose of 6 million units three times a week, 1 000-1 200 mg of ribavirin daily, and 200 mg of amantadine daily in divided doses over 48 wk. After the end of treatment, at the 72nd wk, a sustained viral response rate was determined.RESULTS: An early (after 12 wk of therapy) response was seen in 34.6% (9/26) of patients. Response rate at the 24th wk was 42.3% (11/26). End of treatment response (ETR) was 53.8% (14/26). Sustained viral response (SVR) was 42.3% (11/26). There was a statistically significant difference between 0 and 12 wk (P = 0.04), 0 and 24 wk (P = 0.01), 0 and 48 wk (P = 0.00), and 0 and 72 wk (P = 0.001). No patient had severe adverse effects during the treatment.CONCLUSION: Combination regimen of interferon-α,ribavirin and amantadine can enhance sustained viral response on IFN-α and ribavirin non-responder patients with HCV. Triple therapy with amantadine should be evaluated in further studies.展开更多
AIM: To compare the efficacy and safety of recombinant human IFN β-1a alone or in combination with ribavirin in treatment-na(i)ve subjects with chronic hepatitis C.METHODS: Open, randomized trial was performed in 6 I...AIM: To compare the efficacy and safety of recombinant human IFN β-1a alone or in combination with ribavirin in treatment-na(i)ve subjects with chronic hepatitis C.METHODS: Open, randomized trial was performed in 6 Italian tertiary centers: 102 of the 108 patients screened were randomized to receive 6 MIU of recombinant human IFN β-1a subcutaneously daily for 24 wk, alone (Group 1, n = 51) or in combination with ribavirin 1 000 to 1 200 mg/d (Group 2, n = 51).RESULTS: The end-of-treatment virologic response rate was 29.4% in Group 1 and 41.2% in Group 2 (non-significant). Twenty-four weeks after stopping therapy,sustained virologic response rate was 21.6% in Group 1 and 27.4% in Group 2 (non-significant). All subjects in Group 1 completed treatment, while two subjects in Group 2 stopped therapy due to treatment-related adverse events.CONCLUSION: Recombinant human IFN β-1a, alone or in combination with ribavirin, has an excellent safety profile and, may represent an alternative for chronic hepatitis C patients who are unable to tolerate pegylated α-interferon.展开更多
Objective To assess on-treatment serum HBsAg and HBV DNA kinetics in HBeAg-positive CHB patients to predict the efficacy of pegylated interferon(PEG-IFN) in early phase of treatment. Methods Forty-one treatment-naive ...Objective To assess on-treatment serum HBsAg and HBV DNA kinetics in HBeAg-positive CHB patients to predict the efficacy of pegylated interferon(PEG-IFN) in early phase of treatment. Methods Forty-one treatment-naive HBeAg-positive patients treated with PEG-IFNα 2a at a dose of 180 μg/week for at least 24 weeks were evaluated. Their treatment response was assessed, including normalization of serum ALT, decline of serum HBV DNA and loss of HBeAg. Results We found that a decrease of HBV DNA level at the 4th week was positively correlated with the decrease of HBV DNA level at the 12th week and 24th week(r = 0.8202, P < 0.0001 and r = 0.6838, P < 0.0001, respectively). We observed that a decrease of HBsAg level at the 4th week was positively correlated with decrease of HBsAg level at the 12th week and 24th week(r = 0.4868, P = 0.0023 and r = 0.4251, P = 0.0109, respectively). A decrease of HBsAg level at the 24th week was positively correlated with the decrease of HBV DNA level at the 24th week(r = 0.5262, P = 0.0024). Serum level of IFN and IFN neutralizing antibody had no relationship with HBV DNA or HBsAg titers kinetics. Conclusions The decline of serum HBV DNA and hepatitis B surface antigen at the 4th week can be used to predict the response to PEG-IFNα 2a in patients with HBeAg positive chronic hepatitis B.展开更多
文摘AIM: To evaluate the impact of therapeutic education on adherence to antiviral treatment and sustained virological response (SVR) in a real-life setting in genotype 2/3 hepatitis C,as there are few adherence data in genotype 2/3 infection,even from randomized trials.METHODS: This prospective survey included genotype 2/3 patients who received peg-interferon alfa-2b and ribavirin.There was no intervention.Adherence was self-reported over the past 4 wk (peg-interferon) or 7 d (ribavirin).Adherence to bitherapy was defined as adherence to the two drugs for ≥ 20 wk.SVR was defined as undetectable RNA ≥ 12 wk after the end of treatment.RESULTS: 370/674 patients received education during the first 3 mo of treatment.After 6 mo,adherence to bitherapy was higher in educated patients (61% vs 47%,P = 0.01).Adherence to peg-interferon was 78% vs 69% (P = 0.06).Adherence to ribavirin was 70% vs 56% (P = 0.006).The SVR (77% vs 70%,P = 0.05) and relapse (10% vs 16%,P = 0.09) rates tended to be improved.After adjustment for baseline differences,education improved adherence [Odds ratio (OR) 1.58,P = 0.04] but not the SVR (OR 1.54,P = 0.06).CONCLUSION: In genotype 2/3 patients,therapeutic education helped maintain real-life adherence to bitherapy.
文摘We aim to determine the baseline factors associated with partial and cEVR by analyzing the data of 1861 Egyptian patients treated for 12 weeks with a course of Peg-IFN plus RBV. Base line data of 1861 Egyptian patients with chronic hepatitis C coming at Cairo-Fatemic Hospital for HCV treatment were studied including full clinical, Ultrasonographic examination, laboratory evaluation and liver biopsy. The most significant variables in relation to complete early virological response were low Hb level (13 gm/dl) with p 0.01, the stage of fibrosis p value < 0.05 and the grades of inflammation p value were associated with less achievement of c EVR. We conclude that identifying the most significant predictors of response such as Hb, stage of fibrosis F, at baseline before initiating treatment is mandatory to predict which patient will be more expected to achieve a cEVR and thus reducing the side-effects and healthcare costs associated with interferon therapies.
文摘AIM: To evaluate the efficacy of amantadine plus interferonalpha and ribavirin in non-responder patients with chronic hepatitis C.METHODS: Twenty-six non-responder patients received the regimen of IFN-α-2a at a dose of 6 million units three times a week, 1 000-1 200 mg of ribavirin daily, and 200 mg of amantadine daily in divided doses over 48 wk. After the end of treatment, at the 72nd wk, a sustained viral response rate was determined.RESULTS: An early (after 12 wk of therapy) response was seen in 34.6% (9/26) of patients. Response rate at the 24th wk was 42.3% (11/26). End of treatment response (ETR) was 53.8% (14/26). Sustained viral response (SVR) was 42.3% (11/26). There was a statistically significant difference between 0 and 12 wk (P = 0.04), 0 and 24 wk (P = 0.01), 0 and 48 wk (P = 0.00), and 0 and 72 wk (P = 0.001). No patient had severe adverse effects during the treatment.CONCLUSION: Combination regimen of interferon-α,ribavirin and amantadine can enhance sustained viral response on IFN-α and ribavirin non-responder patients with HCV. Triple therapy with amantadine should be evaluated in further studies.
基金Supported by an Unrestricted Grant From Industria Farmaceutica Serono S.p.A. (Rome, Italy). The Antiviral Drugs Employed in this Study were Also Made Available by Serono
文摘AIM: To compare the efficacy and safety of recombinant human IFN β-1a alone or in combination with ribavirin in treatment-na(i)ve subjects with chronic hepatitis C.METHODS: Open, randomized trial was performed in 6 Italian tertiary centers: 102 of the 108 patients screened were randomized to receive 6 MIU of recombinant human IFN β-1a subcutaneously daily for 24 wk, alone (Group 1, n = 51) or in combination with ribavirin 1 000 to 1 200 mg/d (Group 2, n = 51).RESULTS: The end-of-treatment virologic response rate was 29.4% in Group 1 and 41.2% in Group 2 (non-significant). Twenty-four weeks after stopping therapy,sustained virologic response rate was 21.6% in Group 1 and 27.4% in Group 2 (non-significant). All subjects in Group 1 completed treatment, while two subjects in Group 2 stopped therapy due to treatment-related adverse events.CONCLUSION: Recombinant human IFN β-1a, alone or in combination with ribavirin, has an excellent safety profile and, may represent an alternative for chronic hepatitis C patients who are unable to tolerate pegylated α-interferon.
基金supported by Major Science and Technology Special Project of China Eleventh Five-year Plan(2008ZX10002-004)Major Science and Technology Special Project of China Twelfth Five-year Plan (2012ZX10002003)Natural Science Foundation of China (81101240) to NL
文摘Objective To assess on-treatment serum HBsAg and HBV DNA kinetics in HBeAg-positive CHB patients to predict the efficacy of pegylated interferon(PEG-IFN) in early phase of treatment. Methods Forty-one treatment-naive HBeAg-positive patients treated with PEG-IFNα 2a at a dose of 180 μg/week for at least 24 weeks were evaluated. Their treatment response was assessed, including normalization of serum ALT, decline of serum HBV DNA and loss of HBeAg. Results We found that a decrease of HBV DNA level at the 4th week was positively correlated with the decrease of HBV DNA level at the 12th week and 24th week(r = 0.8202, P < 0.0001 and r = 0.6838, P < 0.0001, respectively). We observed that a decrease of HBsAg level at the 4th week was positively correlated with decrease of HBsAg level at the 12th week and 24th week(r = 0.4868, P = 0.0023 and r = 0.4251, P = 0.0109, respectively). A decrease of HBsAg level at the 24th week was positively correlated with the decrease of HBV DNA level at the 24th week(r = 0.5262, P = 0.0024). Serum level of IFN and IFN neutralizing antibody had no relationship with HBV DNA or HBsAg titers kinetics. Conclusions The decline of serum HBV DNA and hepatitis B surface antigen at the 4th week can be used to predict the response to PEG-IFNα 2a in patients with HBeAg positive chronic hepatitis B.
