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- Title
Predictors of response to tenofovir disoproxil fumarate plus peginterferon alfa-2a combination therapy for chronic hepatitis B.
- Authors
Marcellin, P.; Ahn, S. H.; Chuang, W.‐L.; Hui, A. J.; Tabak, F.; Mehta, R.; Petersen, J.; Lee, C.‐M.; Ma, X.; Caruntu, F. A.; Tak, W. Y.; Elkhashab, M.; Lin, L.; Wu, G.; Martins, E. B; Charuworn, P.; Yee, L. J.; Lim, S. G.; Foster, G. R.; Fung, S.
- Abstract
Background In patients with chronic hepatitis B, tenofovir disoproxil fumarate ( TDF) plus pegylated interferon ( PEG- IFN) for 48-weeks results in higher rates of hepatitis B surface antigen ( HBsAg) loss than either monotherapy. Aim To identify baseline and on-treatment factors associated with HBsAg loss at Week 72 and provide a model for predicting HBsAg loss in patients receiving combination therapy for 48 weeks. Methods A secondary analysis of data from an open-label study where patients were randomised to TDF (300 mg/day, oral) plus PEG- IFN (PI, 180 μg/week, subcutaneous) for 48 weeks ( TDF/ PI-48w); TDF plus PEG- IFN for 16 weeks, TDF for 32 weeks ( TDF/ PI-16w+ TDF-32w); TDF for 120 weeks ( TDF-120w) or PEG- IFN for 48 weeks ( PI-48w). Logistic regression methods were used to identify models that best predicted HBsAg loss at Week 72. Results Rates of HBsAg loss at Week 72 were significantly higher in the TDF/ PI-48w group (6.5%) than in the TDF/PI-16w+TDF-32w (0.5%), TDF-120w (0%) and PI-48w (2.2%) groups ( P = 0.09). The only baseline factor associated with response was genotype A. HBsAg decline at Week 12 or 24 of treatment was associated with HBsAg loss at Week 72 ( P < 0.001). HBsAg decline >3.5 log10 IU/mL at Week 24 in the TDF/ PI-48w group resulted in a positive predictive value of 85% and a negative predictive value of 99% for HBsAg loss at Week 72. Conclusions HBsAg decline at Week 24 of TDF plus PEG- IFN combination therapy may identify patients who, after completing 48 weeks of treatment, have a better chance of achieving HBsAg loss at Week 72.
- Subjects
TENOFOVIR; CHRONIC hepatitis B; HEPATITIS associated antigen; LOGISTIC regression analysis; INTERFERON alpha; THERAPEUTICS
- Publication
Alimentary Pharmacology & Therapeutics, 2016, Vol 44, Issue 9, p957
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/apt.13779