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Patient History

In a patient with recurrent HSV-1 will OTC Docosanol 10 % Cream ( Abreva ) as compared to prescription- strength pills (Acyclovir) decrease the duration of an outbreak when administered in the prodromal stage? LaTesha McLee. Patient History. 32 years old African American female

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Patient History

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  1. In a patient with recurrent HSV-1 will OTC Docosanol 10 % Cream (Abreva) as compared to prescription- strength pills (Acyclovir) decrease the duration of an outbreak when administered in the prodromal stage?LaTeshaMcLee

  2. Patient History • 32 years old African American female • No medications to report, No allergies • Has been getting “cold sores” since she was 12 years old • No contraindications to dental treatment • Chief Complaint: “ How do I make my cold sores go away faster?”

  3. Treatment of Recurrent Herpes Labialis with Oral Acyclovir • Found through PubMed: http://www.ncbi.nlm.nih.gov/pubmed/2153735 • Double-blind, randomized, patient initiated clinical trial • Conducted at 2 locations: University of Utah School of Medicine and University of Michigan School of Dentistry

  4. Methodology • 174 nonimmunocompromised patients—18 years of age or older • All with history of HSV-1 • Treated with Acyclovir capsules, 400 mg capsules five times a day for five days or placebo capsules • For 97 % of the patients treatment started within 1 hour of the first sign or symptom of recurrence ( prodrome stage)

  5. Oral Acyclovir capsules (200 mg)

  6. Summary of Findings • Drug treatment did not affect the development of lesions • Acyclovir did accelerate lesion resolution among patients that could start treatment in the prodrome or erythema lesion stage • For this group the mean duration of pain was reduced by 36 %, and the mean healing time to lost of crust by 27 % • Patients taking the Acyclovir showed a healing response in 5.8 days vs 7.9 days in patients taking the placebo

  7. Summary of Findings (con’t) • In summary, in order for a patient to accomplish a decrease in duration of an outbreak with oral Acyclovir in regards to HSV-1, two conditions must be considered • Patient must be treated in the prodrome or erythema stage • Patient must experience more severe lesions that undergo the classic stages of HSV-1

  8. Oral Acyclovir in Prevention of Herpes Labialis • Found through PubMed: http://www.ncbi.nlm.nih.gov/pubmed/9474615 • Three-center, randomized, double blind, placebo- controlled acyclovir clinical trial • Conducted among Canadian skiers over a two year period

  9. Methodology • 239 patients, 237 were included in the study—18 years of age or older • All had a history of HSV-1—greater than 50 % sun-induced trigger • For a minimum of three days and a maximum of seven days, each patient received 800 mg of oral acyclovir twice a day (1600 mg daily) 12-24 hours prior to sun exposure • Minimum of 3 hours of outdoor activity was mandatory each day • 123 patients received the placebo, 114 patients received acyclovir

  10. Summary of Findings • No difference in healing time in either the acyclovir group or the placebo group for the first 4 days • Patients using the Acyclovir healed slightly faster on days 5 & 6 • Nearly all patients in both groups were healed by day 7

  11. Summary of Findings (con’t) • 5 adverse reactions (Acyclovir group) • Knee throbbing • Constipation • Cold sore discomfort • Stomach ache • Depression • 6 adverse reactions ( Placebo) • 4 instances of headache • 1 instance each of insomnia and diarrhea • All adverse events cleared up in 6 days

  12. Summary of Findings (con’t) In summary, 800 mg of oral acyclovir taken twice a day was not remarkably better than the placebo either in effectiveness, prevention or in adverse effects when it comes to recurrent HSV-1.

  13. Clinical Efficacy of Topical Docosanol 10 % Cream for Herpes Simplex Labialis • Found through PubMed: http://www.ncbi.nlm.nih.gov/pubmed?term=(Herpes%20labialis)%20AND%20docosanol%20topical%20cream • 2 identical double blind, randomized, placebo-controlled clinical trial • Conducted at 21 sites including university clinics, private practices and public health facilities all over the United States • 8 sites were assigned to study 06 and 13 sites to study 07

  14. Methodology • 737- otherwise healthy adults—18 years of age or older • All with a documented history of HSV-1 • Randomized to receive either Docosanol10% Cream or polyethylene glycol placebo • Study drug and placebo were administered in the prodrome or erythema stage • Treatment was administered 5 times daily until healing (crust spontaneously fell off) or there was no longer an active lesion present with twice- daily visits for a maximum of 10 days • Subjects were instructed to reapply after heavy exercise, showering or bathing. • Extra applications were not included in study

  15. Summary of Findings • Median healing time in the 370 Docosanoltreated patients was 4.1 days, 18 hours shorter than observed in the 367 placebo treated patients • From the time of treatment initiation the Docosanol group experienced: • Cessation of pain, tingling, itching and burning • Complete healing of classic lesions • Cessation of ulcer or soft crust stage in classic lesions • Aborted episodes were observed by 40 % in the Docosanolgroup vs 30 % in the placebo group

  16. Summary of Findings (con’t) In summary, when initially administered in the prodrome or erythema stage, and then applied 5 times/daily Docosanol 10 % Cream is safe and effective in the treatment of recurrent HSV-1. Healing time appears to be favorable for the only FDA-approved OTC treatment for HSV-1.

  17. Discussion Because HSV-1 is a virus and there is no cure for it, many lifestyle factors play a major role in the initiation of an outbreak, as well as how frequently an outbreak may occur. The following factors may initiate an HSV-1 outbreak: • Stress • Menstrual cycle/hormonal changes • Pregnancy • Cold/illness • Direct sun exposure

  18. Discussion According to my findings, OTC Docosanol 10 % Cream seems to be more affective in decreasing the duration of an HSV-1 outbreak as compared to oral Acyclovir when administered in the prodrome stage. However, oral Acyclovir as a daily regimen seems to be affective and beneficial in preventing outbreaks in a patient with very frequent outbreaks.

  19. Treatment Plan I recommended the following for my patient: • Docosanol 10% Cream ( Abreva) at the first sign of an outbreak—used as directed • If she notices that she is getting more frequent outbreaks, I suggested that maybe she ask her PCP for a prescription for a daily regimen for oral Acyclovir or similar • Listen to her body, monitor lifestyle factors

  20. References Spruance, S. L., Stewart, J.C.B., Rowe, N. H., McKeough, M. B., Wenerstrom, G., & Freeman, D. J. (1990). Treatment of Recurrent Herpes Labialis with Oral Acyclovir. Journal of Infectious Disease, 161, 185-190. Raborn, G.W., Martel, A, Grace, M.G.A., & McGraw, W.T. (1998). Oral acyclovir in Prevention of Herpes Labialis: Oral Surgery Oral Medicine Oral Pathology, 85, 55-59 Sacks, S. L, Thisted, R. A., Jones, T.M., Barbarash, R. A.,Mikolich, D. J., Ruoff, G. E., …Berg, J. E. (2001). Clinical Efficacy of Topical Docosanol10% Cream for Herpes Simplex Labialis: A Muliticenter, randomized, placebo-controlled trial. Journal of American Academy of Dermatology, 45, 222-230.

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