Treatment of Mucocutaneous Herpes Simplex Virus Infections Unresponsive to Acyclovir With Topical Foscarnet Cream in AIDS Patients: A Phase I/II Study

Abstract

The efficacy and toxicity of foscarnet cream for the treatment of mucocutaneous herpes simplex virus lesions or lesions that were clinically unresponsive to systemic acyclovir treatment (median, 30.5 days) in AIDS patients were studied in a phase I/II, open-label, nonrandomized multicenter trial. In the study, 20 patients with advanced stages of AIDS were treated with foscarnet 1% cream five times a day for a mean duration of 34.5 days. Response of index lesions (n = 20) was judged to be completely healed (8 lesions), excellent (4 lesions), or good (1 lesion) in 65% of lesions. The median time to first negative herpes simplex virus culture of index lesion was 8 days. Among 15 patients with pain at baseline, 11 had complete resolution of pain and 2 had at least a 50% reduction. Clinical adverse events included skin ulceration (4 patients), application site reactions (3 patients), fever (3 patients), and headache (3 patients). Five (25%) patients developed new lesions due to herpes simplex virus at sites other than those being treated topically while enrolled in the study. Topical foscarnet 1% cream appears to be a safe and effective treatment for acyclovir-unresponsive mucocutaneous herpes simplex virus infection in AIDS patients.

2006 United Kingdom National Guideline on the Sexual Health of People with HIV: Sexually Transmitted Infections

“…Both topical 1% foscarnet cream 74,76 and 1% cidofovir gel 77 have been shown to produce significant benefits in lesion healing, pain reduction and virological effect in drug-resistant herpes in PWHIV (evidence level Ib, A).…”

Antiviral Drug Resistance in Herpesviruses

“…Topical formulations of FOS, including a 1 % cream (Javaly et al 1999) and a 2.4 % solution (Pechere et al 1998), were effective in the treatment of mucocutaneous HSV infections unresponsive to ACV. Topical formulations of CDV have been also used successfully for the treatment of drug-resistant mucocutaneous HSV infections (Lalezari et al 1997;Sacks et al 1998;Sims et al 2007;Evans et al 2011).…”

Management of multidrug‐resistant viruses in the immunocompromised host

“…Topical 1% foscarnet preparations have been reported to increase lesional healing in immunosuppressed patients with ACV-resistant HSV, although experience is limited and 1% cream is not commercially available in the UK (Javaly et al, 1999).…”