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PegIFN for HBV, HDV, & HCV
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"LONG TERM EFFECTS OF INTERFERON ALPHA THERAPY INTRAVENOUS DRUG USERS WITH TRIPLE INFECTION BY HEPATITIS B, C AND D VIRUS"
Reported by Jules Levin
Corinne Castelnau, INSERM U481, Clichy, France; Emmanuel Gordien, Service de virologie, Bobigny, France; Nathalie Boyer, Michelle Martinot, INSERM U481, Clichy, France; Paul Deny, Service de Virologie, Avicenne, France; Patrick Marcellin, INSERM U481, Clichy, France
The aim of this study was to evaluate the long term effects of interferon alpha (IFN) therapy in patients with chronic hepatitis related to HBV, HCV and HDV coinfection with or without HIV infection. Often HDV (Delta virus) is present when person has HBV. A blood test is required to check for HDV.
16 males intravenous drug users seen from 1990 to 1994 (9 anti-HIV positive), aged 25-40 years, with chronic active hepatitis were treated for 12 months with recombinant interferon alpha 2b (Intron-a, Schering Plough), at the dose of 10 MU, three times a week. All were positive for HBsAg, IgM anti-delta (HDV) and anti-HCV. All were serum HBV DNA undetectable. HCV RNA was detected by PCR in one patient. 14/16 had detectable HDV RNA. There was no difference between anti-HIV positive and negative patients with respect to duration of drug use, or duration of infection and histologic lesions (cirrhosis in 3 patients).
Sustained response (SR) was defined by normal serum ALT levels, undetectable HDV RNA and absence of IgM anti-delta at the end of the 12 month post-treatment follow-up.
Results
Treatment was interrupted in 5 patients because of decompensated cirrhosis (1), asthenia (3), decrease of CD4 lymphocyte count (1).
12 patients were non-responders (NR) and a sustained response was observed in 4 patients (1 anti-HIV positive). All 4 sustained responders lost HBsAg, IgM anti-delta and HDV RNA.
During long term follow-up (mean 9 years) in the 4 sustained responders: HBsAg, IgM anti-delta and HDV RNA remained negative, and serum ALT levels remained normal, 2/4 developed anti-HBs. 3/4 patients had a liver biopsy after treatment.
One patient, showed a significant improvement of fibrosis with disappearance of necroinflammation; 2/3 with active cirrhosis at baseline showed cirrhosis without activity; immunostaining for liver HDVAg was negative n 3/3.
Nine non responders were followed during 1 to 9 years. 3/9 died of decompensated cirrhosis (anti-HIV positive).
The authors concluded that intravenous drug addicts with chronic hepatitis related to triple B-C-D infection, IFN therapy induced the loss of serum HBsAg and HDV RNA with a long term sustained virological and biochemical response and clinical and histologic improvement.
TREATMENT OF CHRONIC HEPATITIS DELTA WITH PEG-INTERFERON ALPHA-2B
Corinne Castelnau, INSERM U481, Clichy, France; Emmanuel Gordien, Service de Virologie, Bobigny, France; Nathalie Boyer, Michèle Martinot, INSERM U481, Clichy, France; Paul Deny, Service de Virologie, Bobigny, France; Patrick Marcellin, INSERM U481, Clichy, France
Chronic hepatitis delta is a progressive and severe form of liver disease with currently no satisfactory therapy. We evaluated the biochemical, virological and histological effects of a course of one year of peg-interferon (PEG-IFN) alpha-2b (Schering Plough) in 14 patients with chronic hepatitis delta.
14 patients with chronic hepatitis delta were treated with PEG-IFN alpha 2b (Schering-Plough) for one year at a dose of 1.5 MU/kg/ week during 12 months They consisted of 10 men and 4 women, mean age 40 years with a mean duration of infection of 11 years (range 1 to 29). 7 had a history of intravenous drug use and 6 were black Africans. 11/14 were non responders to a first course of conventional IFN. All had abnormal ALT, were positive for HBsAg, IgM anti-delta, hepatitis delta virus (HDV) RNA. All were HBeAg negative with undetectable HBV DNA. Four were anti-HCV positive (with no detectable HCV RNA) and 2 patients were HIV positive. All had a liver biopsy before inclusion. Response was defined by normalization of ALT and negativation of HDV RNA and IgM anti-delta at the end of treatment and at the end of the 6-month follow-up.
RESULTS
13 patients completed therapy (with mild side effects), 6/13 were end of treatment responders and 5 were sustained responders. One patient lost HBsAg during the treatment (month 9). All the 5 sustained responders were non responders to a previous course of IFN. 4/5 demonstrated a marked histologic improvement. The relapser kept normal ALT during the 6 month follow-up. 4/7 of non responders had a liver biopsy. 2/4 showed an improvement and 2/4 an increase in histologic lesions (2 patients HIV positive).
The authors concluded that in patients with chronic hepatitis delta, non responders to conventional IFN, PEG-IFN alpha-2b administered at the dose of 1.5 MU/kg/week during 12 months may induce a sustained virologic response. This study continues to evaluate the long term efficacy.
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