Efficacy of peginterferon α-2a and predictors of response in HBeAg-negative, genotype D-naive patients

Abstract

BackgroundPeginterferon (PEG-IFN) α-2a has been shown to induce a sustained virologic response (SVR) in 20–30% of “hepatitis B e antigen (HBeAg)”-negative patients.AimTo determine the safety and efficacy of PEG-IFN α-2a in HBeAg-negative, genotype D-naive patients and to analyze the predictors of response.MethodsThis prospective, multicenter, open-label, nonrandomized trial was conducted at four hospitals. A total of 35 consecutive HBeAg-negative naive genotype D patients received PEG-IFN α-2a for 48 weeks.ResultsBased on a cutoff of hepatitis B virus (HBV) DNA <400 copies ml−1, an early virologic response (EVR) at week 12, end of treatment virologic response (ETVR) at week 48, and SVR at week 72 were achieved by 3 (9%), 9 (26%), and 8 patients (23%), respectively. The EVR rate improved to 43%, ETVR to 49%, and SVR to 57%, when a HBV DNA cutoff level of <20,000 copies ml−1 was used. Pretreatment HBsAg level was not a predictor for SVR on univariate analysis, but correlated with decline in HBV DNA levels at weeks 48 and 72. On multivariate logistic regression analysis, low body weight, high alanine aminotransferase (ALT), low HBV DNA, and low triglyceride levels were identified as baseline predictors of SVR.ConclusionHBeAg-negative genotype D-naive patients treated with PEG-IFN α-2a achieved SVR in 23 (HBV <400 copies ml−1) and 57% (HBV <20,000 copies ml−1) of patients, a better response than previously reported that might be related to the absence of drug resistance in these naive patients. Pretreatment predictors of SVR were low body weight, high ALT, low HBV DNA, and low triglycerides.

Kinetics of Hepatitis B Surface Antigen Level in Chronic Hepatitis B Patients who Achieved Hepatitis B Surface Antigen Loss during Pegylated Interferon Alpha-2a Treatment

“…IFN has antiviral and immunomodulatory properties that result in direct inhibition of viral replication and enhancement of the cell-mediated immune response in the process of virus clearance. Reportedly, PEG-IFN therapy can only achieve 30–40% HBeAg seroconversion in HBeAg-positive patients, 19.2–40.0% sustained viral response (SVR) after cessation of therapy in HBeAg-negative patients,[ 12 ] and 2.0–7.0% HBsAg loss/seroclearance,[ 8 13 ] which remains far from satisfactory. Even if HBeAg seroconversion and SVR are well-recognized, continuous long-term viral suppression does not ensure HBsAg clearance when treatment is discontinued.…”

Prevalence and characterization of occult hepatitis B infection among blood donors in central Saudi Arabia

“… 24 It has been reported that treatment of HBV genotype D infections in the absence of HBeAg with peginterferon alpha-2a for 72 weeks reduced the viral load to <400 copies/mL in only 23% of the patients. 33 Compared with this observation therapy with the nucleoside analogues such as entecavir, or tenofovir for 48 weeks has been shown to reduce the viral load to undetectable levels in 58.4-66% of the HBV infected patients with negative HBeAg. 34 , 35 In the current study, the majority of OBIs identified (88.2%) were genotype D. However, the result obtained was not surprising since the vast majority of HBV infections in Saudi Arabia are genotype D. 24 Similar to our study, a study conducted on blood donors from Italy and Poland showed that the prevalence of HBV genotype D among OBIs was significantly higher than that of other genotypes.…”

Prevalence and characterization of occult hepatitis B infection among blood donors in central Saudi Arabia

“…It has been reported that treatment of HBV genotype D infections in the absence of HBeAg with peginterferon alpha-2a for 72 weeks reduced the viral load to <400 copies/mL in only 23% of the patients 33. Compared with this observation therapy with the nucleoside analogues such as entecavir, or tenofovir for 48 weeks has been shown to reduce the viral load to undetectable levels in 58.4-66% of the HBV infected patients with negative HBeAg 34,35.…”