AEGiS-CATIE: Cidofovir for herpes

Cidofovir for herpes

TreatmentUpdate84 - Vol. 9, No. 10 - pp. 4; December, 1997
Sean Hosein

In people with HIV infection, weakened immunity--perhaps caused by dysfunctional CD8+ cells--allows herpes infection to get out of control. The virus that causes these lesions is called HSV (herpes simplex virus). Skin lesions caused by the virus can be painful and may grow worse if left untreated. Standard treatment is acyclovir tablets or cream. In cases where the virus has become resistant to acyclovir, there are few convenient options. Foscarnet and ganciclovir can be used, but they have side effects and must be given intravenously. Viroptic (trifluridine) eye drops have been successfully used to treat lesions in some people. Now the drug cidofovir (Vistide), in the form of a gel has been found to cause herpes lesions to heal in about 30% of treated people. Although this version of the drug is not licensed anywhere, the drug is available on a compassionate basis from Gilead Sciences at 1-800-445-3235.

Study Details

Thirty PHAs (4 female, 26 male) were enrolled in this study; their average CD4+ cell count was about 9 cells. Some subjects had used foscarnet and/or Viroptic prior to entering this study to control their lesions. All subjects had used oral acyclovir at least 1 gram/day for 10 days or iv acyclovir 15mg/kg/day for 10 days without obtaining relief. Researchers divided subjects into three groups; one group received fake cidofovir gel (placebo), another got cidofovir 0.3% gel and the last received cidofovir 1% gel. Neither doctors nor subjects knew who received which product. Subjects applied the gel to their lesions for 5 consecutive days followed by 10 days of observation. After this time all subjects could get further treatment with cidofovir if the lesions did not shrink or if new ones appeared.

Results

Complete healing of lesions occurred in 30% of subjects receiving cidofovir, 3 of 11 (27%) PHAs receiving cidofovir 0.3% gel and 3 of 9 receiving the cidofovir 1% gel. No subject receiving placebo had their lesions heal. These differences between subjects on placebo and subjects on cidofovir were statistically significant; that is, not likely due to chance alone. Three of the 6 subjects whose lesions healed later had them recur. Healing of the lesions was not connected to CD4+ cell counts, gender or the length of time people were infected with HSV. Subjects on cidofovir also experienced less pain from their lesions than did subjects on placebo. Cidofovir also greatly reduced production of HSV in treated lesions.

Toxicity

"Over 80%" of subjects experienced minor side effects, mainly "burning, pain or itching" in their lesions. In subjects receiving fake cidofovir the figure was 80%.

The FDA has so far refused to approve cidofovir gel for the treatment of herpes lesions. The manufacturer, Gilead Sciences, has made the drug available on a compassionate basis to people with HSV lesions that do not heal when treated with acyclovir. Doctors may contact the company for further details at 1-800-445-3235.

REFERENCES:

1. Lalezari J, Schacker T, Feinberg J, et al. A randomzied, double-blind, placebo-controlled trial of cidofovir gel for the treatment of acyclovir-unresponsive mucocutaneous herpes simplex virus infection in patients with AIDS. Journal of Infectious Diseases 1997;176:892-898.

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