PROVE1 trial, 1 in which in the group with an identical treatment schedule, the percentage of patients obtaining SVR with respect to RVR was 75% only. In other words, RVR seems easier to obtain with telaprevir, but less frequently predicts a favorable treatment outcome. A possible explanation might
HBeAg and hepatitis B virus DNA as outcome predictors during therapy with peginterferon alfa-2a for HBeAg-positive chronic hepatitis B
โ Scribed by Michael W. Fried; Teerha Piratvisuth; George K. K. Lau; Patrick Marcellin; Wan-Cheng Chow; Graham Cooksley; Kang-Xian Luo; Seung Woon Paik; Yun-Fan Liaw; Peter Button; Matei Popescu
- Publisher
- John Wiley and Sons
- Year
- 2008
- Tongue
- English
- Weight
- 414 KB
- Volume
- 47
- Category
- Article
- ISSN
- 0270-9139
No coin nor oath required. For personal study only.
โฆ Synopsis
The aims of this study were to evaluate the usefulness of quantitative hepatitis B e antigen (HBeAg) values for predicting HBeAg seroconversion in patients treated with peginterferon alfa-2a and to assess the dynamic changes in quantitative HBeAg during therapy, compared with conventional measures of serum hepatitis B virus DNA. Data were analyzed from a large, randomized, multinational phase III registration trial involving 271 HBV-infected HBeAg-positive patients who received peginterferon alfa-2a plus oral placebo for 48 weeks. HBeAg levels were measured serially during therapy using a microparticle enzyme immunoassay validated with in-house reference standards obtained from the Paul Ehrlich Institute (PEIU/mL). In patients who achieved HBeAg seroconversion, levels of HBeAg consistently decreased during treatment and remained at their lowest level during the 24 weeks of posttreatment follow-up. After 24 weeks of treatment, 4% of patients with the highest levels of HBeAg (>100 PEIU/mL) achieved HBeAg seroconversion, yielding a negative predictive value of 96%, which was greater than that obtained for levels of HBV DNA (86%). Late responders to peginterferon alfa-2a could also be differentiated from nonresponders by continued decrease in HBeAg values, which were not evident by changes in HBV DNA. Conclusion: These analyses suggest quantitative HBeAg is a useful adjunctive measurement for predicting HBeAg seroconversion in patients treated with peginterferon when considering both sensitivity and specificity compared with serum HBV DNA.
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Ferenci is a consultant for, advises, is on the speakers' bureau of, and received grants from Roche. Dr. Janssen is a consultant for and received grants from Roche, Bristol-Myers Squibb, Schering-Plough, Novartis, and Gilead. Dr. Flisiak received grants from Roche.
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