Nucleos(t)ide analogues (NAs) and peginterferon have complementary effects inchronic hepatitis B, but it is unclear whether combination therapy improvesresponses in genotype D-infected patients. We conducted an open-label study ofpeginterferon alfa-2a 180 μg/wk added to ongoing NA therapy in hepatitis Be antigen (HBeAg)-negative, genotype D-infected patients with hepatitis B virusDNA <20 IU/mL. The primary endpoint was proportion of patients with ≥50% declinein serum HBsAg by the end of the 48-week add-on phase. Seventy patients receivedtreatment, 11 were withdrawn at week 24 for no decrease in HBsAg, and 14 withdrewfor other reasons. Response rate (per-protocol population) was 67.4% (29/43) atweek 48 (95% confidence interval [CI]: 51, 81) and 50.9% (28/55) at week 96 (95% CI:38, 66). Median serum HBsAg decreased throughout peginterferonalfa-2a treatment and was significantly lower than baseline at weeks 48, 72 and 96(P < 0.001). Decreases in HBsAg of ≥0.5-log10 and ≥1-log10 were documented in 19(44.2%) and 6 (14.0%) patients at week 48 and 6 (10.9%) and 17 (30.9%) patients atweek 96. The proportion of patients with HBsAg <1000, <500, <100 and <10 IU/mLat ≥1 timepoint during treatment was 78.6% (n = 44), 57.1% (n = 32), 21.4% (n = 12)and 7.1% (n = 4). Interferon gamma-induced protein 10 increased from baseline up toweek 48, with week 12 levels significantly associated with response at week 48.Addition of peginterferon alfa-2a to ongoing NA therapy significantly decreasedHBsAg levels in HBeAg-negative patients with genotype D infection (ClinicalTrials.gov NCT01706575).
|Numero di pagine||8|
|Rivista||Journal of Viral Hepatitis|
|Stato di pubblicazione||Published - 2019|