The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.
Number of Participants With a Virological Response
For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).
Time frame: 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation
Number of Participants With a Biochemical Response
A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.
Time frame: 52 weeks (EOT), 104 weeks (EOF)
Number of Participants With a Combined Response
The combined response was defined as an ALT level below the upper reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L.
Time frame: 52 weeks (EOT), 104 weeks (EOF)
Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)
Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum.
Time frame: 52 week (EOT)
Number of Participants With a Liver Histology Response
The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis \[0-10\], lobular inflammation \[0-4\], portal inflammation \[0-4\], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored \[0-4\]) in the pre- and post-treatment liver biopsies. The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT.
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Time frame: Baseline and 52 week (EOT)