Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Saturday, 11 November 1996.
"This double-blind study is very important because for the first time we have shown that famciclovir is significantly effective in reducing both hepatitis B virus replication and the amount of alanine aminotransferase (ALT), a liver enzyme which is abnormally increased in patients with chronic hepatitis B," explains lead study researcher Professor Christian Trepo from the Liver Unit, Hotel Dieu, Lyon, France.
The study involved 333 patients with chronic hepatitis B from 64 centers in 14 countries. Seventy-three percent of patients were male, the majority (75 percent) were Caucasian, but a significant minority (23 percent) were Asian, a group known to respond poorly to traditional treatment with interferon therapy. All patients had markers (HBs Ag and HBe Ag - hepatitis B antigens) for active, chronic hepatitis B infection for at least six months and showed ongoing replication of the hepatitis B virus (tested positive for the presence of hepatitis B virus DNA, a highly sensitive marker of active hepatitis B virus replication). Patients were randomized to receive 16 weeks of treatment with Famvir (500 mg, 250 mg or 125 mg) or placebo three times a day. This cohort of patients were particularly difficult to treat as 41 percent had previously failed to respond to prior interferon therapy, most had very high hepatitis B virus DNA levels (median 3,600 picograms) and the median ALT was very low (1.7 times upper limit of normal range).
"Famciclovir treatment resulted in a rapid, dose-dependent suppression of hepatitis B virus replication," says Professor Trepo. "In all famciclovir treatment groups, the effect on hepatitis B virus DNA levels was evident within one week of therapy (p<0.0001) and was maintained throughout the 16 week treatment period.
"All doses of famciclovir significantly reduced patients' levels of ALT. More importantly, the normalization of liver enzymes was sustained eight months after the 16 week treatment period in 50 percent of patients in the famciclovir 500 mg group. This is the first time that a prolonged benefit has been shown after short term therapy with a nucleoside analogue. It may indicate that famciclovir has, in effect, 'incapacitated' the hepatitis B virus multiplication," Professor Trepo explains.
In the famciclovir 500 mg three times daily treatment group, by the end of the study, there was significantly more seroconversion (loss of the antigen HBe Ag and appearance of antibodies to HBe Ag) compared to the placebo group (p=0.04). Seroconversion indicates that a person is mounting an immune response to the hepatitis B virus by producing antibodies to fight the infection.
"This unexpected finding is potentially very exciting," Professor Trepo commented. "It will be interesting to see whether the finding is confirmed in the longer term famciclovir studies currently ongoing."
The safety profile of famciclovir was found to be comparable to placebo with no serious adverse events related to famciclovir treatment.
"These data reinforce the safety observed in liver transplant patients treated up to three years with famciclovir," adds Professor Trepo.
Worldwide, there are an estimated 350 million hepatitis B carriers (or five percent of the world's population). Each year, an additional 10 to 30 million people are expected to become infected with the hepatitis B virus. In addition, many carriers may not experience symptoms and are unaware that they could be passing on this potentially fatal disease to others. In the United States, infection is most often transmitted through sexual contact or exposure to infected blood.
The aim of chronic hepatitis B treatment is to stop the virus from replicating to prevent ongoing liver damage, cirrhosis and liver cancer. Interferon is currently the most widely used antiviral agent for the treatment of hepatitis B.
The success rate of interferon in terms of inducing seroconversion varies between 14 and 75 percent depending on the age when hepatitis B infection is acquired, race and immune function of the patient and severity of liver disease.
Side effects of interferon treatment include a "flu-like" illness with headache, muscle pain, diarrhea, nausea, reversible hair loss and depression. There is also a genetically-engineered vaccine to prevent hepatitis B infection that has been available since 1989.
Famciclovir (Famvir), first launched in the U.K. in 1994, is a product of SmithKline Beecham (NYSE: SBH). In the United States, Famvir is currently indicated for recurrent genital herpes and the treatment of acute herpes zoster (shingles) in immunocompetent individuals. Famvir is being studied for the treatment of a number of other infections caused by the viruses belonging to the family of human herpesviruses in both immunocompetent and immunocompromised individuals. In addition, a major trial is currently underway to determine the effects of Famvir on herpes latency/reactivation by assessing recurrences of genital herpes after treatment of the patient's first episode.
SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures, and markets pharmaceuticals, vaccines, over-the-counter medicines, and health-related consumer products, and provides healthcare services including clinical laboratory testing, disease management, and pharmaceutical benefit management. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com.
CONTACT: Sharyn Arnold, 215-751-7074, for SmithKline Beecham
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