AEGiS-08IAC: ACTG 172: treatment of acyclovir-resistant (ACV-R) mucocutaneous herpes simplex virus (HSV) infection in patients with AIDS: open label pilot study of topical trifluridine (TFT).

8th International AIDS Conference

Amsterdam, Netherlands — July 19-24, 1992

ACTG 172: treatment of acyclovir-resistant (ACV-R) mucocutaneous herpes simplex virus (HSV) infection in patients with AIDS: open label pilot study of topical trifluridine (TFT).

Int Conf AIDS 1992 Jul 19-24; 8:We55 (abstract no. WeB 1056)
Kessler H, Weaver D, Benson C, Pottage J, Safrin S, Nevin T, Davis R, Owens S, Korvick J; Rush Medical College, Chicago, IL.

OBJECTIVES: Effective treatment of ACV-R HSV infections in patients with AIDS is currently limited to intravenous foscarnet (FOS). We evaluated the efficacy of topically applied TFT, an anti-HSV nucleoside analogue in an open pilot, multi-center study.

METHODS: Patients with mucocutaneous HSV lesions unresponsive to greater than or equal to 2 weeks of therapy with oral or parenteral ACV were eligible for study. TFT 1% ophthalmic solution was applied as a thin film to each lesion and was covered with bacitracin/polymyxin ointment and a nonabsorbent dressing t.i.d. Ulcers were treated for 10 to 42 days, with extension of therapy if lesions were responding but not completely healed.

RESULTS: Nine patients (7 M, 2 F) with anogenital (6) or facial (3) ulcers have been treated to date. Ulcers were present a median of 13 weeks (range 2-182) before starting TFT therapy and median ulcer size was 11 cm2 (range 0.36-147 cm2). Seven of 9 patients have responded to therapy. Four patients healed completely in a median of 32 days (range 21-73). Three patients are currently on study a median of 24 days (range 15-30) and all are responding (greater than 50% healing, 2 patients). Two female patients with anogenital lesions did not complete therapy. One (poorly compliant) had no response to 20 days of treatment and one had greater than or equal to 25% healing after 34 days but developed oral HSV-1 and was treated with ACV. One patient relapsed 8 weeks after therapy. Median in vitro susceptibility (IC50) of HSV isolates was less than 0.5 ug/ml (range less than 0.5-1.74 ug/ml). No drug related toxicity was reported.

CONCLUSIONS: Topical TFT as a 1% ophthalmic solution may be an effective alternative therapy for the treatment of ACV-R HSV disease in patients with AIDS. Formulation in a more convenient delivery vehicle warrants further investigation.

Keywords: AEGIS, Acyclovir, Trifluridine, Simplexvirus, Acquired Immunodeficiency Syndrome, Foscarnet, Infection, Antiviral Agents, Herpesvirus 1, Human, AIDS-Related Opportunistic Infections, Reverse Transcriptase Inhibitors, Female, In Vitro, Human, therapy, diagnosis, drug therapy, ICA8
920719
WeB1056