PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Tuesday July 29, 1997 9:59 AM EDT

"There are very few herpes treatments that are safe for use in HIV-infected and other immunocompromised individuals," said Barbara Romanowski, M.D., clinical professor, division of medical microbiology and immunology, University of Alberta and director of sexually transmitted disease services at Alberta Health. "Famvir may soon offer a safe and effective treatment option with a convenient dosing schedule. Convenient dosing is especially important for HIV-infected patients who often take a lot of medications, because it might help increase compliance."

Herpesvirus Infections Common in Immunocompromised Patients

Herpesvirus infections are often more severe in immunocompromised patients than in otherwise healthy adults. In these patients, the herpes virus can spread to other parts of the body such as the liver or lungs which is potentially life threatening. Recurrent genital herpes infections in immunocompromised patients are more painful and produce more necrosis (tissue damage) than in immunocompetent patients. Furthermore, several studies have shown that infection with certain sexually transmitted diseases such as genital herpes may increase the likelihood of transmitting HIV.

Shingles, which is the same virus that causes chicken pox, is characterized by an outbreak of painful and itchy blister-like sores which may last up to six weeks. Immunocompromised patients are at a greater risk of having a shingles attack, and multiple recurrences have been reported in this patient population. Shingles affects an estimated 850,000 Americans each year and is eight times more likely to develop in HIV-infected patients than in otherwise healthy adults.

Studies Show Famvir is An Effective and Convenient Treatment

In a double-blind, acyclovir controlled multicenter study, 148 immunocompromised patients (bone marrow transplant recipients and cancer patients) with herpes zoster were randomized to receive either Famvir 500 mg three times daily or acyclovir 800 mg five times daily for ten days. The median time to complete healing of all lesions was comparable for patients treated with either Famvir or acyclovir. In addition, there were no significant differences between both treatment groups in times to loss of lesion associated symptoms or new lesion formation.

In a separate double-blind, acyclovir controlled multicenter study, 293 HIV-infected patients with HSV disease were treated within 48 hours of lesion onset with either Famvir 500 mg twice daily or acyclovir 400 mg five times daily for seven days. Famvir was comparable to acyclovir in preventing new lesion formation and in median time to complete healing of all lesions. Furthermore, there were no significant differences in times to loss of lesion associated symptoms or cessation of viral shedding.

"This is an important step forward in the management of herpes virus infections in immunocompromised patients," said Dr. Jerry Karabelas, executive vice president, SmithKline Beecham Pharmaceuticals. "Clinical trials have shown that Famvir is a safe and effective treatment option that can be taken less frequently than the currently available treatment. This improved convenience is good news for patients and the physicians who treat them."

Famvir was generally well-tolerated. The most commonly reported side effects observed in both trials included headache, nausea and malaise. Famvir is the oral form of penciclovir and is rapidly absorbed into the body's bloodstream, providing a 77 percent rate of bioavailability versus 15 percent for acyclovir. It is a potent antiviral agent with activity against the herpes viruses. In addition, Famvir has a long intracellular half-life in infected cells in vitro (10-20 hours in herpesvirus infected cells versus one hour or less for acyclovir).

Famvir is indicated for the treatment of recurrent genital herpes and acute herpes zoster in immunocompetent individuals. SmithKline Beecham has filed a new drug application with the FDA for the use of penciclovir IV in the treatment of mucocutaneous herpes simplex and herpes zoster infections in immunocompromised individuals. Other studies are ongoing to evaluate the use of Famvir in the treatment of herpes virus infections in immunocompetent and immunocompromised individuals. In addition, studies are ongoing in the treatment of chronic hepatitis B virus infection.

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.

SOURCE: SmithKline Beecham

Contact: Sharyn Arnold of SmithKline Beecham, 215-751-7074; or Suzanne Sheirr, of Cohn & Wolfe, 212-598-3693

Copyright (c) 1997/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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