Tools for Practice


#94 Simplicity for simplex (cold sores): a pill in the pocket takes the tingling away


CLINICAL QUESTION
Do antivirals (oral or topical) or docosanol (Abreva®) improve healing time for patients with recurrent herpes labialis (cold sores)?

BOTTOM LINE
One or two doses of famciclovir may improve cold sore healing by about 2 days, while valacyclovir and longer courses of topical acyclovir or docosanol (Abreva®) may improve healing by 0.5-1 day. 


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EVIDENCE
Placebo-controlled randomized controlled trials (RCT) of: 
  • Immunocompetent patients with recurrent cold sores (most ≥3 episodes/year). 
  • Starting treatment ≤1 hour of prodrome symptoms (unless specified). 
Oral antivirals: 
  • Three larger RCTs: 
    • Famciclovir: 1500mg x1 or 750mg BID x1 day (477 patients).1 
    • Valacyclovir: 1 day (2g BID) or 2 day (2g BID then 1g BID) (1856 patients).2 
    • Acyclovir: 400mg 5 times/day x5 days (174 patients).3 
  • Healing time improvement: 
    • Famciclovir: 2-2.5 days. 
    • Valacyclovir: 0.5~1 day. 
    • Acyclovir: not significant.  
Topical acyclovir: 
  • RCT: acyclovir 5% cream 5 times/day x4 days (1341 patients).4 
    • Healing time improved ~0.5 day.  
Docosanol 10% (Abreva®): 
  • RCT: docosanol 5 times/day started <12 hours of symptoms until healing occurred (743 patients).5 
    • Healing time improved ~0.75 day.  
Limitations: 
  • No direct comparisons of different oral agents.1,2 
  • Many studies industry-supported1-4,5 and by same author.1-4 
Context:  
  • Antivirals generally help cold sores heal in 4-5 days versus 5-6 days.1-4 
  • 35% of patients experience >4 recurrences per year.6  
  • Cost for treating one recurrence (using study dose regimens):  
    • Oral antivirals: ~$20 (valacyclovir 1 day) to $44 (acyclovir 5 days). 
    • Topical acyclovir (4g) ~$40 or docosanol (2g) ~$25. 
  • Health Canada has approved only valacyclovir for treating cold sores,7 while FDA has approved valacyclovir,8 famciclovir9 and acyclovir9,11 (oral and topical).  
updated jan 29, 2018
August 19, 2013

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Author(s):

  • Hoan LInh Banh BScPharm PharmD
  • Michael R Kolber MD CCFP MSc
  • Tony Nickonchuk BScPharm CDE APA

1. Spruance SL, Bodsworth N, Resnick H, et al. Single-dose, patient-initiated famciclovir: A randomized, double-blind, placebo-controlled trial for episodic treatment of herpes labialis. J Am Acad Dermatology. 2006; 55:47-53.

2. Spruance SL, Jones TM, Blatte MM, et al. High-dose, short duration, early valacyclovir therapy for episodic treatment of cold sores: results of two randomized, placebo-controlled, multicenter studies. Antimicrob Agents Chemother. 2003; 47:1072-80.

3. Spruance SL, Stewart JC, Rowe NH, et al. Treatment of recurrent herpes simplex labialis with oral acyclovir. J Infect Dis. 1990; 161:185-90.

4. Spruance SL, net R, Marbury T, et al. Acyclovir cream for treatment of herpes simplex labialis: results of two randomized, double-blind, vehicle-controlled, multicenter clinical trials. Antimicrob Agents Chemother. 2002; 46:2238-43.

5. Sacks SL, Thisted RA, Jones TM, et al. Clinical efficacy of topical docosanol 10% cream for herpes simplex labialis: a multicenter, randomized, placebo-controlled trial. J Am AcadDermatol. 2001; 45:222-30.

6. Dreno B, Malkin JE, Saiag P, et al. Patients’ profile, burden of disease and quality of life in recurrent herpes labialis: a survey conducted in USA and France. Journal of the European Academy of Dermatology and Venereology. 2012; 26:1454-60.

7. Valtrex [drug product monograph].Mississauga, ON. GlaxoSmithKline Inc, 2009.

8. FDA Drug efficacy supplemental approval in 2002. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/EfficacySupplementApprovals/ucm081883.htm. Accessed June 7, 2013.

9. FDA Drug efficacy supplemental approval in 2006. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/EfficacySupplementApprovals/ucm081895.htm. Accessed June 7, 2013.

10. Zovirax (capsules, tablets, suspension) [package insert]. Research Triangle Park, NC. GlaxoSmithKline, 2007.

11. Zovirax (5% cream) [package insert]. Research Triangle Park, NC. GlaxoSmithKline, 2011.

Authors do not have any conflicts of interest to declare.