Abstract
BackgroundThis study aimed to evaluate the predictive values of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) levels in 171 Chinese patients with chronic hepatitis B who received a 48-week course of pegylated interferon alfa-2b therapy at 1.5 mcg/kg.MethodsHBsAg, HBeAg, and hepatitis B virus (HBV) DNA levels were measured at baseline and weeks 12, 24, 48, and 72. Clinical responses were defined as a combined response (CR, HBeAg seroconversion [sustained response, SR] combined with HBV DNA level <2,000 IU/mL at week 72). The positive predictive value and negative predictive value were calculated for HBsAg alone and/or combined with HBeAg and HBV DNA at weeks 12 and 24.ResultsOf 171 patients included, 58 (33.9 %) achieved a SR. Of patients who achieved a SR, 33 (56.9 %) achieved a CR. Totally 19.3 % (33/171) patients achieved CR and 80.7 % (138/171) patients did not. Patients with HBsAg <1500 IU/mL at week 12 had a 47.4 % chance of achieving an off-treatment SR and patients with a HBsAg decrease >1.5 logIU/mL at week 12 had a 54.5 % chance. Patients with HBsAg >20,000 IU/mL at weeks 12 and 24 had a 93.8 and 100.0 % chance, respectively, of not achieving a CR. An HBsAg level or changes at weeks 12 and 24, combined with HBeAg or HBV DNA, increased the chance for a SR and CR.ConclusionsOn-treatment HBsAg quantification, alone or in combination with HBeAg or HBV DNA, predicted off-treatment SR and CR after 48 weeks of PEG-IFNα-2b therapy, and thus, may guide clinicians in making a therapeutic decision to continue or terminate the therapy.
Highlights
This study aimed to evaluate the predictive values of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) levels in 171 Chinese patients with chronic hepatitis B who received a 48-week course of pegylated interferon alfa-2b therapy at 1.5 mcg/kg
The present study aimed to evaluate the predictive values of on-treatment HBsAg, alone or combination with HBeAg and hepatitis B virus (HBV) DNA, for different clinical responses in Chinese HBeAg-positive Chronic hepatitis B (CHB) patients treated with Pegylated interferon (PEG-IFN) alfa-2b
Patients were eligible for the P05170 study if they were between 18 and 65 years of age, had CHB for at least 6 months, were positive for HBeAg and HBsAg, had an alanine aminotransferase (ALT) level between 2 and 10 times of upper limit of normal (ULN) range, had HBV DNA levels exceeding 20,000 IU/mL, and had not received IFN therapy within the previous 6 months
Summary
This study aimed to evaluate the predictive values of hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) levels in 171 Chinese patients with chronic hepatitis B who received a 48-week course of pegylated interferon alfa-2b therapy at 1.5 mcg/kg. Induction of a sustained off-therapy virological and biochemical response in HBeAg-negative patients (either HBeAg-positive cases at baseline with durable anti-HBe seroconversion or HBeAg-negative cases from baseline) is a satisfactory end point, because it has been shown to be associated with. Pegylated interferon (PEGIFN) possesses both antiviral and immunomodulatory effects and is one recommended therapy for CHB patients [7,8,9]. PEG-IFN can produce a robust off-treatment response in CHB patients [10,11,12,13]. Several virological biomarkers such as HBsAg, HBeAg, and HBV DNA levels are reported to be predictive of the long-term response with PEGIFN treatment [15,16,17,18,19,20,21]
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