FDA approves herpes drug for HIV patients

The U.S. Food and Drug Administration in Rockville, MD, recently approved Famvir (famciclovir) manufactured by SmithKline Beecham in Philadelphia for the treatment of recurrent herpes simplex virus (HSV) in HIV-infected patients. Nearly 95% of all HIV-infected patients also are infected with either HSV-1, HSV-2, or both, with studies suggesting that genital herpes is a major co-factor in the spread of HIV.

Herpes infections are one of the most commonly diagnosed infections among HIV/AIDS patients. These infections are often more painful and produce more tissue damage in HIV-infected individuals than in otherwise healthy adults. In addition, HIV-infected individuals experience more frequent and severe outbreaks than those in healthy adults. HSV can spread to other parts of the body such as the liver or lungs, causing potentially life-threatening complications. In addition, open HSV lesions formed during outbreaks facilitate the transmission of HIV.

In a double-blind, multicenter study, 293 HIV patients with recurrent genital herpes or cold sores were treated within 48 hours of lesion onset with either famciclovir 500 mg twice daily or a high dose of acyclovir 400 mg five times daily for seven days. Although roughly 40% of the 293 patients had CD4 counts below 200 cells/mm3, famciclovir was effective in healing herpes lesions and reducing new lesion formation.

Twice-daily dosing significant consideration

Acyclovir was also effective in treating herpes lesions; however, the fact that famciclovir must only be taken twice daily is significant, says Sorana Segal-Maurer, MD, with New York Medical Center of Queens. "People with AIDS are typically taking large amounts of medications that require frequent dosing, making noncompliance a common problem. The fact that Famvir needs to be taken only twice a day is significant, given the fact that missing even one or two pills on a more frequent regimen may compromise the overall effectiveness of a patient's treatment," says Segal-Maurer, who specializes in the treatment of HIV.

Famvir is the oral form of penciclovir. it is rapidly absorbed in the bloodstream and provides 77% bioavailability.