Comparative study of three doses of interferon‐α2a in chronic active hepatitis B

Abstract

To determine the efficacy of interferon-alpha 2a in chronic active hepatitis B, 238 patients were randomly divided, into four groups: three groups received either 2.5 MIU m-2, 5.0 MIU m-2 or 10.0 MIU m-2, three times weekly by intramuscular injection for 12-24 weeks; and a control group received no treatment. Patients were followed for up to 12 months after treatment was discontinued. There was a statistically significant difference in response [clearance of hepatitis B e antigen (HBeAg) and hepatitis B viral DNA (HBV-DNA)] between treated and untreated patients (37 vs 13%) but no statistically significant difference was seen between treatment groups (33%, 34% and 43% for the 2.5, 5.0 and 10.0 MIU m-2 groups, respectively). A transient rise in transaminases (seroconversion hepatitis) was seen in responders, but levels returned to within the normal range after response to treatment. In patients responding to interferon therapy there was a significant reduction in the severity of the hepatitis. Interferon-alpha 2a was generally well tolerated with respect to vital signs and laboratory parameters.

Retreatment of chronic hepatitis B e antigen-positive patients with recombinant interferon alfa-2a

“…The dose and treatment duration were selected because better results are obtained with doses of 4.5 to 18 MU 3 times per week during 12 to 24 weeks 6,8,14 and with prolongation of the treatment period. 13 For these reasons, a 6-month treatment course was chosen with a dose of 9 MU of recombinant IFN (rIFN)-␣-2a (Roferon-A, F. Hoffmann-La Roche, Basel, Switzerland), subcutaneously, 3 times per week.…”

“…At that time, 62 patients who were HBeAg-and HBV DNA-positive in serum with abnormal ALT values (documented at least 3 times within the 6 months screening period) and a chronic HBV 12 documented in a liver biopsy obtained within 1 year before inclusion had been enrolled. The patients should have undergone a previous treatment of only one course of any type of IFN-␣ treatment (recombinant or lymphoblastoid) for at least 12 weeks with a minimum of 13.5 million units (MU) per week 8,13 ; at the end of the first IFN-␣ cycle ( at least 6 months before enrollment in this study) patients should have been HBeAg-positive.…”

“…At that time, 62 patients who were HBeAg-and HBV DNA-positive in serum with abnormal ALT values (documented at least 3 times within the 6 months screening period) and a chronic HBV 12 documented in a liver biopsy obtained within 1 year before inclusion had been enrolled. The patients should have undergone a previous treatment of only one course of any type of IFN-␣ treatment (recombinant or lymphoblastoid) for at least 12 weeks with a minimum of 13.5 million units (MU) per week 8,13 ; at the end of the first IFN-␣ cycle ( at least 6 months before enrollment in this study) patients should have been HBeAg-positive.The following patient exclusion criteria were used: (1) evidence of any other type of liver disease, i.e., anti-hepatitis C virus or anti-hepatitis D virus positive, alcohol, ascites, bleeding varices, or Abbreviations: HBV, hepatitis B virus; HBeAg, hepatitis B virus e antigen; ALT, alanine transaminase; HBsAg, hepatitis B virus surface antigen; IFN-␣, interferon alfa.From the …”

“…1,2 Interferon alfa (IFN-␣) has been used as therapy for this disease, leading to a sustained loss of HBV DNA and hepatitis B e antigen (HBeAg) (and seroconversion to anti-HBe) and biochemical improvement (normalization of alanine transaminase [ALT] values) in around 25% to 40% of the treated patients. [2][3][4][5][6][7][8][9][10] However, the remaining patients do not achieve a response, including those patients who relapse after achieving an initial response and patients who do not respond. These patients may potentially benefit from another cycle of IFN-␣ treatment.…”

Sustained response to peginterferon alfa-2a (40 kD) with or without lamivudine in Asian patients with HBeAg-positive and HBeAg-negative chronic hepatitis B

“…Probably, as a result of perinatal infection with predominantly genotype C, Asian patients have traditionally been considered to have difficult-to-treat CHB, as overall experience in clinical trials suggest that a nonAsian ethnic origin is predictive of a favorable response [4]. Although Asian patients were found to have a response similar to that of non-Asians, where levels of hepatitis B deoxyribonucleic acid (HBV DNA) and alanine aminotransferase (ALT) were comparable [5], predominantly they tend to have higher levels of viral DNA and lower levels of ALT than non-Asians [6]. The genotype of HBV also appears to affect the outcome of therapy with interferon, with higher response rates noted for genotypes A and B than for genotypes D and C [7,8].…”