Recent Approval of Xerese in Canada: 5% Acyclovir and 1% Hydrocortisone Topical Cream in the Treatment of Herpes Labialis

Harrison P. Nguyen, BA; Kelly R. Stiegel, BS; Christopher Downing, MD; Stephen K. Tyring, MD, PhD, MBA


Skin Therapy Letter. 2014;19(3) 

In This Article

Other Therapies for Herpes Labialis

Prior to the authorization of Xerese™ by Health Canada, the mainstays of treatment for recurrent HSL included over-thecounter docosanol cream, and prescription-only members of the acyclovir family (oral and topical). If ACHC is contraindicated for use in a particular patient due to adverse effects, docosanol or acyclovir may provide therapeutic benefit.

Docosanol 10% cream (Abreva®) is an approved treatment for recurrent herpes labialis, with efficacy demonstrated in two identical double-blind, placebo-controlled studies conducted at 21 sites.[13] Therapy was initiated at the onset of prodromal symptoms or the erythema stage in subjects who were otherwise healthy adults with documented histories of herpes labialis. Treatment was administered 5 times daily until healing occurred, with twice-daily visits to the investigative clinic for the first 7 days. For the 370 patients who were treated with docosanol, the median time to heal was 4.1 days, which was 18 hours shorter than the healing time for the 367 patients treated with placebo ( Table 2 ). The patients treated with docosanol also reported earlier cessation of pain and exhibited complete healing, as well as experienced reduced lesion progression to the ulcer or soft crust stage.

A well-established mainstay in the treatment of recurrent herpes labialis is valacyclovir. This prodrug of acyclovir has proven to be a safe and effective therapy for long-term HSV suppression.[14] It has been studied in children, pregnancy, and immunocompromised patients. The most common adverse events associated with oral valacyclovir are headache, rhinitis, infection, nausea, and pharyngitis, with all of these occurring infrequently. Despite many years of use by clinicians, HSV resistance remains low at approximately 0.1–0.4% in the UK and the US.[14]

A new form of acyclovir was recently approved by the US FDA in April 2013. This medication consists of acyclovir in the form of a mucoadhesive buccal tablet (ABT) (Sitavig®), which is applied to the upper gum region within the first hour of prodromal symptoms. A Phase 3 double-blind trial found that acyclovir, utilizing the proprietary Lauriad® technology, decreased the median duration time and development of primary vesicular lesions when compared to placebo ( Table 1 and Table 2 ).[15]

Lastly, a non-pharmacologic treatment for recurrent HSL involves low-level light therapy. A paper published in 2013 demonstrated that 1072 nm light-emitting diode therapy applied 3 times a day for 2 days was able to shorten healing time in patients with HSL to a median of 129 hours vs. 177 hours for the control group ( Table 2 ).[16]