Acyclovir is used topically as a 5% cream for the treatment of recurrent herpes labialis (perioral herpes, cold sores, fever blisters) in immunocompetent individuals. Acyclovir is used topically as a 5% ointment in the treatment of limited, non-life-threatening, mucocutaneous herpes simplex virus (HSV-1 and HSV-2) infections in immunocompromised individuals. The manufacturer states that acyclovir ointment may be used topically for the management of initial genital herpes; however, topical therapy is not usually recommended for the treatment of genital herpes.
For systemic uses of acyclovir,
Acyclovir 5% cream is used topically for the treatment of recurrent herpes labialis (perioral herpes, cold sores, fever blisters) in immunocompetent adults and children 12 years of age or older. Efficacy of acyclovir 5% cream in immunocompromised individuals has not been established. In 2 randomized, double-blind, vehicle-controlled studies in immunocompetent adults with a history of recurrent herpes labialis (at least 3 episodes during the past year), self initiation of topical acyclovir 5% cream within 1 hour of onset of prodromal symptoms or the first clinical sign of herpes labialis decreased the duration of the episode and also decreased patient-assessed duration of pain. In these studies, the mean duration of herpes labialis episodes for patients with a known duration was 4.3-4.6 days in those treated with topical acyclovir versus 4.8-5.2 days in those treated with vehicle cream; the mean patient-assessed duration of pain was 2.9-3.1 days and 3.2-3.5 days, respectively. There was no evidence that use of topical acyclovir prevented the development of classic herpes labialis lesions (progression to vesicles, ulcers, and/or crusts).
In immunocompromised adults with herpes labialis (oral and perioral herpes), topical application of acyclovir 5% ointment to the lesions has decreased the duration of viral shedding and the duration of pain. In one study, acyclovir was not effective in reducing total healing time or delaying the onset of recurrent infections. However, in this study, the duration of viral shedding (time from patient enrollment in the study until 2 consecutive negative cultures were obtained) was 2.5 days in acyclovir-treated patients compared with 9.5 days in placebo-treated patients; pain persisted for more than 3 weeks after onset of illness in 10% of acyclovir-treated patients and in about 50% of placebo-treated patients.
Acyclovir 5% ointment has been used in the treatment of initial episodes of genital herpes in adults. However, topical antiviral agents are not recommended for the treatment of genital herpes since these agents offer only minimal clinical benefit. The US Centers for Disease Control and Prevention (CDC) and some clinicians recommend that oral acyclovir, oral famciclovir, or oral valacyclovir be used for the treatment of first episodes of genital herpes, episodic treatment of recurrent infections, or suppressive therapy of recurrent infections in immunocompetent adults and adolescents.
Controlled studies of first episodes of genital herpes infections, both primary and non-primary, have shown that topical therapy with acyclovir 5% ointment does not reduce the frequency or delay the time of appearance of new lesions following initiation of treatment, nor does it delay the onset of recurrent infections. However, topical therapy with acyclovir generally decreases the duration of viral shedding (time from onset of therapy until the last positive culture), the duration of pain and itching, and the time required for crusting and healing of lesions in these patients.
Studies of treatment of recurrent genital herpes infections have generally shown little if any therapeutic benefit following topical therapy with acyclovir 5% ointment. In controlled studies in patients (males and females) with recurrent infections, topical acyclovir appeared to decrease the duration of viral shedding and modestly reduce the time required for crusting and healing of lesions in males. No significant effect on healing or crusting of lesions was noted in females. No significant reduction in duration or degree of pain or itching was noted in patients of either sex. Acyclovir has not been effective in reducing the frequency or delaying the onset of subsequent recurrent infections. Similar disappointing results have occurred when topical acyclovir therapy for the prevention of recurrent genital herpes infections was initiated immediately following the development of prodromal symptoms (e.g., itching, burning, tingling, numbness). In one large, placebo-controlled, multicenter study, the duration of viral shedding was reduced in females, but not males, and the time required for crusting was reduced in males, but not females; however, these reductions were of borderline significance only and there was no evidence of symptomatic improvement with acyclovir nor other differences compared with placebo.
For information on current recommendations for the treatment of genital herpes, see Uses: Genital Herpes, in Acyclovir 8:18.32.
Mucocutaneous Herpes Simplex Virus (HSV) Infections
Acyclovir 5% ointment is used topically in the treatment of limited, non-life-threatening, nongenital, mucocutaneous HSV-1 and HSV-2 infections in immunocompromised adults. However, systemic therapy (e.g., oral or IV acyclovir) generally is preferred for the treatment of mucocutaneous herpes simplex infections in immunocompromised individuals.
Ophthalmic HSV Infections
An ophthalmic ointment containing acyclovir 3% (not currently available) has been used in the topical treatment of HSV ophthalmic infections; however, commercially available acyclovir 5% ointment should not be applied to the eye.
For other uses of acyclovir, see 8:18.32.