Intravenous penciclovir for treatment of herpes simplex infections in immunocompromised patients: Results of a multicenter, acyclovir-controlled trial

The efficacy and safety of penciclovir (PCV) for the treatment of herpes si mplex virus (HSV) infections in immunocompromised OC) patients were studied in a double-blind, acyclovir (ACV)-controlled, multicenter study. A total of 342 patients with mucocutaneous HSV infections received 5 mg of PCV per kg every 12 or 8 h (q12h or q8h) or 5 mg of ACV per kg q8h, beginning withi n 72 h of lesion onset and continuing for up to 7 days. The mean age of the patients was 49 years; 94% were,white and 52% were female. The main reason s for their IC states were hematologic disorder (63%) and transplant plus h ematologic disorder (16%). Clinical and virological assessments were perfor med daily during the 7-day treatment and then every other day until lesion healing. The primary efficacy parameter addressed new lesion formation. Sec ondary end points focused on viral shedding, healing, and pain. Approximate ly 20% of patients in each treatment group developed new lesions during the rapy; thus, equivalence with ACV (defined prospectively) was demonstrated f or both q12h and q8h PCV regimens. For all three treatment groups, the medi an time to the cessation of viral shedding was 4 days and the median time t o complete healing was 8 days; there were no statistically significant diff erences in the rates of complete healing or the cessation of viral shedding when the results for PCV q12h and q8h were compared with those for ACV q8h . In addition, there was no statistically significant difference between PC V q12h or q8h, compared with ACV q8h, for the resolution of pain. PCV was w ell tolerated, with an adverse event profile comparable to that of ACV. In conclusion, PCV q12h is a well-tolerated and effective therapy for mucocuta neous HSV infection in IC patients and offers a reduced frequency of dosing compared with ACV q8h.