This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine (LAM). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96.
Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48.
Unnamed facility
Bari, Apulia, Italy
Unnamed facility
Castellana Grotte, Apulia, Italy
Unnamed facility
Percentage of Participants Achieving the Combined Response at the End of the Follow-up Period
Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to \<20,000 copies/mL (\<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.
Time frame: At the end of the 48-week follow-up period at Week 144
Percentage of Participants Achieving the Combined Response at the End of Treatment
Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to \<20,000 copies/mL (\<3,400 IU/mL). In case of missing end of treatment measurements, the next available post-treatment value was used.
Time frame: At end of treatment at Week 48 or 96 depending on the study arm
Percentage of Participants Achieving the Combined Response at 24 Weeks of Follow-up
Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to \<20,000 copies/mL (\<3,400 IU/mL). In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used.
Time frame: At the end of 24 weeks of follow-up at Week 120
Percentage of Participants Achieving Combined Response Using a Cut-Off for HBV-DNA Levels to 2,000 IU/mL
Combined response was defined here as ALT normalization plus lowering HBV-DNA levels to a cutt-off \<2,000 IU/mL. In case of missing end of treatment measurements, the next available post-treatment value was used. In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
San Giovanni Rotondo, Apulia, Italy
Unnamed facility
Caserta, Campania, Italy
Unnamed facility
Naples, Campania, Italy
Unnamed facility
Naples, Campania, Italy
Unnamed facility
Bologna, Emilia-Romagna, Italy
Unnamed facility
Parma, Emilia-Romagna, Italy
Unnamed facility
Reggio Emilia, Emilia-Romagna, Italy
Unnamed facility
Trieste, Friuli Venezia Giulia, Italy
...and 12 more locations
Time frame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144
Percentage of Participants Achieving Histological Response
Histological response was defined as an improvement by \>/= 2 in the Necroinflammatory Grading and/or by an improvement by \>/= 1 score in Fibrosis Staging according to Ishak. Necroinflammatory Grading ranges 0-14 and is the combined score for necrosis, range 0-10 and inflammation, range 0-4. The participant is scored for only one inflammatory condition. A higher score indicates worse condition. Fibrosis Staging according to Ishak ranges 0-6 and a higher score indicates greater fibrosis.
Time frame: At the end of the 48-week follow-up period at Week 144
Change From Baseline of Quantitative Hepatitis B Surface Antigen (HbsAg) Level at the End of Treatment
Time frame: At the end of treatment at Week 48 or 96 depending on the study arm
Percentage of Participants With Lamivudine Genotype Resistance During PEG-IFN+LAM96 Combined Therapy
Lamivudine resistance mutations were assessed by detection of the following mutations: rtL80V, rtL80I, rtV173G, rtV173L, rtL180M, rtA181T, rtA181V, rtM204V, rtM204I and rtN236T.
Time frame: At the end of the treatment period at Week 96