Current management and recommendations for access to antiviral therapy of herpes labialis.

Herpes labialis is a common skin infective condition, worldwide, which is primarily caused by HSV-1. Recurrent episodes of herpes labialis, also known as cold sores, can be frequent, painful, long-lasting and disfiguring for infected patients. At present, there are two types of antivirals for the treatment of herpes labialis, topical and oral, which are available over the counter or as prescription-only. The aim of antiviral therapy is to block viral replication to enable shortening the duration of symptoms and to accelerate healing of the lesions associated with herpes labialis. This review examines the evidence for the effectiveness of current topical and oral antivirals in the management of recurrent episodes of herpes labialis. In most countries, oral antivirals for herpes labialis are available as prescription-only. However, in early 2010, the oral antiviral famciclovir was reclassified from prescription-only medicine to pharmacist-controlled status in New Zealand. The benefits and risks associated with moving an antiviral therapy for herpes labialis from prescription-only to pharmacist-controlled status are reviewed here, and the implications for patients, general physicians and pharmacists are considered.

Oral antivirals for the acute treatment of recurrent herpes labialis.

OBJECTIVE: To evaluate the use and benefit of oral antivirals in the acute treatment of episodic, recurrent herpes labialis. DATA SOURCES: A literature search was performed in MEDLINE (1966-August 2003) using acyclovir, famciclovir, valacyclovir, cold sores, herpes labialis, and HSV-1 as search terms. DATA SYNTHESIS: We reviewed 5 placebo-controlled and 2 comparative studies evaluating oral antivirals for acute treatment of recurrent herpes labialis. No studies directly compared different antivirals. Studies discussing the efficacy of antivirals for chronic suppression of herpes simplex virus-1 infection were not included. CONCLUSIONS: Treatment with oral antivirals decreases the duration of lesion episodes and pain by approximately one day; however, the antivirals do not abort lesions from developing. Clinical implications of these results appear relatively modest.

Antiviral therapy for herpes zoster: randomized, controlled clinical trial of valacyclovir and famciclovir therapy in immunocompetent patients 50 years and older.

OBJECTIVE: To compare the efficacy and safety of valacyclovir hydrochloride and famciclovir for the treatment of herpes zoster. DESIGN: A double-blind, randomized, controlled, multicenter clinical trial in which patients received 7 days of treatment and were followed up for 24 weeks. SETTINGS: Patients reported directly to specialist centers or were referred from primary care centers. PATIENTS: There were 597 otherwise healthy immunocompetent outpatients, aged 50 years and older, who presented within 72 hours of onset of zoster rash. INTERVENTIONS: Treatment with valacyclovir hydrochloride (1 g 3 times daily) or famciclovir (500 mg 3 times daily) for 7 days. MAIN OUTCOME MEASURES: Resolution of zoster-associated pain and postherpetic neuralgia, rash healing, and treatment safety. RESULTS: Intent-to-treat analysis did not detect statistically significant differences for valacyclovir vs famciclovir on resolution of zoster-associated pain (hazard ratio, 1. 02; 95% confidence interval, 0.84-1.23; P =.84). Furthermore, no differences were evident between treatments on rash healing rates and on a range of analyses of postherpetic neuralgia. Safety profiles for valacyclovir and famciclovir were similar, with headache and nausea being the more common adverse events. CONCLUSIONS: Valacyclovir treatment is comparable to famciclovir treatment in speeding the resolution of zoster-associated pain and postherpetic neuralgia. Current wholesale prices indicate that valacyclovir is the more cost-effective treatment for herpes zoster ($83.90 vs $140.70 per course).

Cost effectiveness of newer antiviral agents for herpes zoster: is the evidence spotty?

Famciclovir and valaciclovir were approved for use in the treatment of herpes zoster despite controversy over antiviral therapy in zoster due to high costs and uncertain benefits. To explore these issues, a Markov decision model was developed, and the incremental cost effectiveness of antiviral treatment for herpes zoster was estimated using these agents compared with no antiviral therapy. A third-party payer perspective was taken. Sensitivity analyses were performed, modeling differences in antiviral efficacy, postherpetic neuralgia (PHN) risk, and other illness parameters. Treatment of severely symptomatic acute zoster was found reasonable from a cost-effectiveness standpoint in base-case and worst-case scenarios. Treatment of mildly symptomatic acute zoster was more expensive but would likely be considered cost effective in scenarios where PHN risk was higher, PHN duration longer, or antiviral shortening of PHN greater. Further research comparing antiviral efficacy in herpes zoster is needed.

Economic evaluation of famciclovir in reducing the duration of postherpetic neuralgia.

The economic impact of famciclovir therapy for postherpetic neuralgia (PHN) in patients with acute herpes zoster was studied. A decision-analytic model of the treatment of herpes zoster and PHN was used to compare the cost of PHN between patients treated with oral famciclovir 500 mg three times daily for seven days and patients not receiving any antiviral therapy. The effects of famciclovir on PHN in the model were based on the results of a randomized, double-blind trial in 419 adult outpatients. The cost of the course of famciclovir therapy (21 tablets) was estimated as the sum of the drug's wholesale acquisition cost and the pharmacy dispensing cost. The cost of treating PHN (physician visits, medications, and miscellaneous nondrug therapy) was estimated by consulting a panel of physicians. According to the model, the cost of treating PHN was $85 lower per famciclovir recipient ($294 for famciclovir versus $379 for no antiviral therapy). The net cost of famciclovir therapy was $23 per patient ($108 for acquisition and dispensing minus the $85 savings). Among patients 50 years of age or older, famciclovir reduced the average cost of PHN by $155 ($414 for famciclovir versus $569 for no antiviral therapy) and yielded a net savings of $7 per patient. A model for the use of famciclovir to treat acute herpes zoster showed that the cost of such therapy was largely offset by savings in the cost of treating this complication.

[Prevention of hepatitis B--analysis of cost-effectiveness after liver transplantation]. / HBV-Prophylaxe--Kosten/Nutzenanalyse nach Lebertransplantation.

HBV recurrence, despite immunoprophylaxis which occurred in 67% of our patients, remains the main problem following liver transplantation for HBV infection. Pretransplant viral replication (HBV-DNA) and probably viral mutation may account to some degree for the failures involved in hyperimmunoglobulin prophylaxis. In order to improve the cost/benefit relationship, only HBV-DNA and HBeAG-negative patients should be selected or preoperatively seroconverted by nucleosides (famciclovir, lamivudine); post-operatively a variable HIG prophylaxis should be administered.