Abstract
Herpes simplex virus (HSV) orolabial and anogenital infection causes substantial and recurring disease in healthy individuals due directly to infection of these sites and, indirectly, due to its complications. These complications include eczema herpeticum plus erythema multiforme and neonatal HSV infection, respectively. Four drugs: acyclovir, famciclovir, valacyclovir and penciclovir, are currently licensed by the Therapeutics Products Directorate of Health Canada for the management of HSV infections. Although these drugs are only approved for four orolabial and anogenital infections in healthy persons, their efficacy and safety for 13 other related uses in this population have been demonstrated in controlled clinical trials, so called off-label uses. In this review, the evidence supporting these 17 uses, the drugs and regimens evaluated, and their current costs, are described.
Highlights
Herpes simplex virus (HSV) orolabial and anogenital infection causes substantial and recurring disease in healthy individuals due directly to infection of these sites and, indirectly, due to its complications
The pharmacological therapy of oral and genital herpes simplex virus (HSV) infection in the immunocompetent host has been dominated by acyclovir (ACV)
Reported clinical trials have reinforced our knowledge about appropriate antiviral drug treatments for these infections, while other trials have identified noteworthy off-label uses, which is to say, uses demonstrated in controlled clinical trials for which formal approval has not been sought from or granted by the Therapeutic Products Directorate (TPD) of Health Canada
Summary
Contemporary antiviral drug regimens for the prevention and treatment of orolabial and anogenital herpes simplex virus infection in the normal host: Four approved indications and 13 off-label uses. Four drugs: acyclovir, famciclovir, valacyclovir and penciclovir, are currently licensed by the Therapeutics Products Directorate of Health Canada for the management of HSV infections These drugs are only approved for four orolabial and anogenital infections in healthy persons, their efficacy and safety for 13 other related uses in this population have been demonstrated in controlled clinical trials, so called off-label uses. In spite of the numerous controlled trials reported, there is a general paucity of studies directly comparing the relative merits of the available drugs This has left the physician with little evidence to use to select among the available agents, ACV and PCV, and their respective oral prodrugs, VCV and FCV.
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