Researchers from the Medizinische Hochschule in Hannover, Germany in association with the clinic of infective diseases at the University of Bari, Italy have shown that treatment of acute hepatitis C with interferon alfa-2b prevents chronic infection.
Because of the potential clinical implications the study was published early on the internet at the website of The New England Journal of Medicine. It will also appear in the November 15 paper edition.
Hepatitis C (HCV) affects around 170 million people worldwide. Between 15 and 20% of people exposed to the virus clear it spontaneously. For the majority, however, chronic infection is established. Current estimates suggest that around 10% of HCV-positive people will develop cirrhosis (liver scarring) in 20 years and this figure may rise as high as 30% as further time progresses. Chronic HCV infection can also lead to liver cancer and liver transplantation.
Treatments for chronic hepatitis C infection have been developed and have been improving over the past few years, though at best, HCV is eradicated in around 50% of patients.
There is no standard therapy for acute infection.
Between 1998 and 2001 44 patients with acute HCV infection were enrolled into the study. The mean age of participants was 36. In total, 25 were women. The reported modes of infection were; intravenous drug use (9), needle-stick injury (14), medical procedures (7), sexual contact (10) and undetermined (4).
The average time since infection and the onset of hepatitis-related symptoms was 54 days. On average, treatment was initiated 89 days after infection. In total 27 patients (61%) had HCV genotype 1 (in chronic infection this genotype requires longer treatment and is associated with a less favorable response to therapy). None of the patients in the study were HIV co-infected.
Patients received 5 million units of interferon alfa-2b subcutaneously daily for 4 weeks, then three times weekly for a further 20 weeks. Only one patient dropped out of the study because of side-effects.
Response to treatment was not influenced by the viral genotype, patient’s sex or the mode of transmission.
Twenty-four weeks after the completion of therapy, 98% (42/43) of patients had undetectable HCV RNA and normal serum alanine amino transferase (ALT) levels. It is likely that a limited proportion of these patients would have cleared the virus on exposure. However, at present, there are no means to identify such patients.
No placebo group was included in the study. However, researchers were able to compare their results with a group of untreated patients who were seen and followed during a similar observation period (1995 to 2000). In total 70% of these patients proceeded to chronic infection.
Treatment at such an early stage has distinct advantages for the patient; treatment may potentially be for a shorter period than might be required if chronic infection is established: the use of interferon monotherapy and the exclusion of ribavirin may decrease the occurrence of side-effects, and improve quality of life. Further improvements in quality of life may be seen if pegylated interferon were used, as this only requires once weekly subcutaneous injection. Studies of this drug at acute infection should be highly recommended.
Early identification and treatment of HCV represents our best chance to eradicate the virus and significantly decrease complications from the virus and the likelihood of death.
Jaeckel, E et al. Treatment of Acute Hepatitis C with Interferon Alfa-2b. The New England Journal of Medicine, 15 November 2001.
Freeman A et al. Estimating Progression to Cirrhosis in Hepatitis C Virus Infection. Hepatology 2001; 809-16.