Peginterferon alfa-2a and peginterferon alfa-2b combined with ribavirin in patients with genotype 1 chronic hepatitis C: results of a prospective single-centre study.

PURPOSE: This prospective, randomized, single-centre study compared peginterferons alfa-2a and alfa-2b, combined with ribavirin, in treating patients infected with hepatitis C virus (HCV) genotype 1. MATERIAL/METHODS: Hundred-and-one patients received 48 weeks of open-label treatment with peginterferon alfa-2a (180 µg/week) and 111 patients received peginterferon alfa-2b (1.5 µg/kg/week). All patients received the same dose of ribavirin 1000/1200 mg/day, depending on weight. The primary efficacy endpoint was sustained virologic response (SVR), defined as undetectable HCV RNA (<50 IU/mL) 24 weeks after the end of treatment. RESULTS: Early virologic response (EVR), defined as at least 2 log10 IU/mL reduction of viral load at 12 weeks, was more common in patients treated with peginterferon alfa-2a (88% vs. 74.8%; p=0.04). However, the difference in SVR was not statistically significant (49.5% vs. 44.1%; p=0.43). CONCLUSIONS: Peginterferon alfa-2a treated patients were also more likely to be HCV RNA negative at the end of treatment (67.3% vs. 57.7%), but this difference did not reach statistical significance. Multivariate logistic regression analysis found that SVR was associated with low fibrosis stage (F1-2 by Scheuer; p=0.001) and low serum HCV RNA level (<400,000 IU/L; p=0.023). While both forms of peginterferon showed similar efficacy as measured by SVR, use of peginterferon alfa-2b could lower the number of patients receiving unnecessary treatment beyond 12 weeks.

[Results of 48 weeks lamivudine treatment of patients with chronic hepatitis B and HBeAg (-)]. / Ocena skutecznosci leczenia lamiwudyna przez 48 tygodni pacjentów z przewleklym wirusowym zapaleniem watroby typu b HBeag(-).

Lamivudine is an oral nucleoside analogue with strong antiviral activity against hepatitis B virus. The HBeAg-negative patients tend to have lower serum HBV viral loads when compared to HBeAg-positive patients, but may develop liver disease. The objective of this study was to analyse the efficacy of lamivudine treatment of chronic hepatitis B patients negative in HBe antigen (HBe-Ag-negative). 102 patients were treated in Hospital of Infectious Diseases in Warsaw in the years 2001-2002. Patients were treated for 48 weeks with 100 mg lamivudine once daily (50 mg in case of renal failure). The end point of therapy of patients with chronic HBV infection negative for e antigen is more difficult to determine than for HBeAg-positive patients because HBeAg seroconversion marker cannot be applied. The only useful markers of therapy efficiency are the supression of HBV DNA replication and normalization ofALT activity level. Results at the end of therapy: normalization of ALT activity was observed in 48,7% patients, inhibition of viral replication was detected in 65,6% patients. The results are comparablewith known randomized clinical trials.

[Results of 48 weeks lamivudine treatment of patients with chronic hepatitis B and HBeAg (+)]. / Ocena skutecznosci leczenia lamiwudyna przez 48 tygodni pacjentów z przewleklym wirusowym zapaleniem watroby typu B HBeAG (+).

Chronic hepatitis B is an important public health problem worldwide. In Poland the incidence rate decreased from 40,0 (in the year 1990) to 3,86 (in 2004) per 100,000 inhabitants. The goal of anti-chronic hepatitis B therapy is to prevent the progression of liver disease to cirrhosis which may effect in development of liver failure or HCC. The aims of treatment are: reduction of HBV viral load and normalization of ALT activity. Among HBeAg positive patients important marker is the loss of e antigenemia followed by seroconversion to anti-HBe positivity. Lamivudine is an oral nucleoside analogue with strong antiviral activity against hepatitis B virus. The objective of this study was to analyse the efficacy of lamivudine treatment of chronic hepatitis B patients positive for hepatitis B e antigen (HBeAg). 224 patients were treated in Hospital of Infectious Diseases in Warsaw in the years 2001-2002. Patients were treated for 48 weeks with 100 mg lamivudine once daily (50 mg in case of renal failure). Results obtained at the end of therapy: loss of HBeAg was observed in 33,4% and seroconversion to anti-HBe in 15,1% patients, normalization of ALT activity was noticed in 53,4% patients, inhibition of HBV DNA replication was observed in 37,9% patients. The results are comparable with known randomized clinical trials.

[Study of the efficacy of combined therapy with interferon alfacon-1 and ribavirin for chronic hepatitis C]. / Ocena skutecznosci leczenia skojarzonego interferonem alfacon-1 i rybawiryna pacjentów z przewleklym wirusowym zapaleniem watroby typu c.

The results of combined interferon alfacon-1 and ribavirin therapy of 94 patients with chronic hepatitis C were analyzed. Complete data, including sustained viral response (SVR), were obtained in 88 patients. 46.8% of them achieved SVR. The most important factor influencing SVR, was the presence of HCV RNA in serum at weeks 12 and 24 of therapy. SVR in these cases was achieved in 14.3% and 0%, respectively. Eight patients discontinued therapy due to adverse events. Most frequent were depressive reactions due to interferon (3 cases), and severe anemia due to ribavirin (2 cases). 37% of patients developed thyroiditis, significantly more frequent in women (27 versus 9).

[Comparison of early virologic response among patients with chronic hepatitis C infected with genotype non 2/3 treated with pegylated interferon alfa-2B and ribavirin in dependence with hepatic fibrosis stages]. / Porównanie wczesnej odpowiedzi wirusologicznej w zaleznosci od zaawansowania wlóknienia u pacjentów z przewleklym wirusowym zapaleniem watroby typu c zakazonych genotypem innym niz 2 i 3 leczonych pegylowanym interferonem alfa-2B i rybawiryna.

Early virologic response (EVR) depending on various hepatic fibrosis was analyzed at 12 week of pegylated interferon alfa-2b (Pegintron, 12 KD) with ribavirin treatment among chronic hepatitis C patients (pts) infected with genotype non 2/3. The A group composed 29 pts. They were of staging 0 and grading 1. The group B composed 47 pts of staging 1, C 33 pts of staging 2, D 35 pts of staging 3 and 4. Liver biopsies were analyzed according to the Scheuer's and Knodell's scores. Early virologic response (ERV) was defined as decrease of VL >2 log or undetectable HCV RNA. Viral load (VL) was determined with HCV RNA Assay and CA HCV Monitor Test (Roche Diagn. Sys.). The EVR rates for the A, B, C, D groups were as follow: 86,2% (25/29), 80,9% (38/47), 75,8% (25/33) and 60% (15/25), respectively.

[Pegylated interferon-alfa 2a with ribavirin in chronic viral hepatitis C (final report)]. / Pegylowany interferon alpha-2a z rybawiryna w leczeniu przewleklego wirusowego zapalenia watroby typu C (raport koncowy z badan).

UNLABELLED: We evaluated the efficacy and safety of peginterferon alfa-2a [40KD] (Peg-IFNalpha-2a) plus ribavirin in patients with chronic hepatitis C in an open-label programme in a routine clinical setting in Poland. Patients received Peg-IFNalpha-2a 180mg/week plus ribavirin 800-1200 mg/d for 48 weeks. Sustained virological response (SVR) was defined as undetectable HCV RNA (<50IU/mL) at the end of follow-up (week 72). 466 adults were enrolled. Most patients (87.3%) had genotype 1 infection. 440 subjects (94,4%) completed treatment. The overall SVR rate was 55.7%. A higher SVR rate was obtained in treatment-naïve patients (58.7%) than in relapsers (47.8%; p=0,048). SVR rates in genotype 1 and non-1 patients were 51.1% and 88.5%, respectively (p<0.001). There were significant higher SVR rates in patients with lower baseline fibrosis (p=0,01). There were no differences in SVRs by gender or viral load. Hemoglobin, leukocyte and neutrophil levels decreased significantly during treatment, but returned to baseline after the end of treatment. ALT levels decreased significantly during treatment in patients with and without an SVR. 38.4% of patients experienced adverse events like neutropenia, anemia, thrombocytopenia, and other. There was one death (severe thrombocytopenia). CONCLUSIONS: The overall SVR achieved in this predominantly genotype 1 population was 55.7%. SVR rates were significantly higher in treatment-naïve patients, those with non-1 genotypes, and in patients with lower baseline fibrosis scores.