Efficacy and safety of famciclovir for treating mucocutaneous herpes simplex infection in HIV-infected individuals. Collaborative Famciclovir HIV Study Group.
OBJECTIVE
To compare the efficacy and safety of 7 days' treatment with famciclovir 500 mg twice a day versus acyclovir 400 mg five times a day, for mucocutaneous herpes simplex virus (HSV) infection in HIV-infected individuals.


METHODS
Randomized, double-blind, parallel-group study to demonstrate equivalence for the primary efficacy parameter.


METHODS
Forty-eight hospital-based or specialist public-health clinics in 12 countries.


METHODS
Two-hundred and ninety-three HIV-positive patients with recurrent HSV infection (orolabial or genital) starting treatment within 48 h of first appearance of herpetic lesions.


METHODS
Proportion of patients developing new lesions during treatment (primary outcome measures); Time to complete healing of lesions, time to cessation of viral shedding, time to loss of lesion-associated symptoms, number of withdrawals due to treatment failure (secondary outcome measures).


RESULTS
Equivalence was defined prospectively and famciclovir was equivalent to acyclovir in preventing new lesion formation: new lesions occurred in 16.7% and 13.3% of patients, respectively [difference, 3.4%; 95% confidence interval (CI), -4.8-11.5]. The groups were comparable in time to complete healing (median 7 days for both groups; hazard ratio, 1.01; 95% CI, 0.79-1.29; P = 0.95), cessation of viral shedding (median of 2 days [hazard ratio = 0.93; 95% C.I. 0.68, 1.27; p = 0.64]), and loss of lesion-associated symptoms (median 4 days; hazard ratio, 0.99; 95% CI, 0.75-1.30; P = 0.93). Similar numbers in each group withdrew because of treatment failure. There were no differences between groups in the incidence of adverse events.


CONCLUSIONS
Famciclovir given twice a day is as effective and well tolerated as high-dose acyclovir for mucocutaneous HSV infections in HIV-infected individuals, and has the convenience of less frequent dosing.
Romanowski
B
B
Medical Microbiology and Immunology, Edmonton, Alberta, Canada.
Aoki
F Y
FY
Martel
A Y
AY
Lavender
E A
EA
Parsons
J E
JE
Saltzman
R L
RL
D015075:2-Aminopurine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000212:Acyclovir / Q000627:therapeutic use*; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D000077595:Famciclovir; D005260:Female; D015658:HIV Infections; D006679:HIV Seropositivity; D006561:Herpes Simplex / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011355:Prodrugs / Q000627:therapeutic use; D013997:Time Factors
D000998:Antiviral Agents; D011355:Prodrugs; D015075:2-Aminopurine; D000077595:Famciclovir; D000212:Acyclovir