1. Evaluation of effectiveness and safety of acyclovir 1gm twice a day for treatment of recurrent genital herpes Kaushal Verma, M Sunane, Somesh Gupta All India Institute of Medical Sciences New Delhi, India E-mail: prokverma@hotmail.com Conflict of interest – None

3. Introduction ♦ Chronic relapsing disease, with recurrent genital vesicles/ painful erosions ♦ Sexual acquisition of HSV (HSV2>> HSV1) ♦ HSV maintains latent infection in nerve ganglion  recurrent episodes ♦ Recurrent rates usually declines with time ♦ Not a fatal disease

4. Why Treat !!! ♦ Lesions on important body sites ♦ Palliation and promotion of healing ♦ Reducing transmission ♦ Suppression of recurrences ♦ Abort or reduce the duration of episodes ♦ Prevention of complications

5. Challenges in management ♦ Lack of cure & unpredictable nature of recurrences ♦ Cost & compliance issue with suppressive therapy ♦ Communication & counseling issues ♦ Significant impact on Quality of life ♦ Grief reaction to diagnosis ♦ Sexual difficulties: fear of transmission impaired function ♦ Asymptomatic viral shedding ♦ Accounts for 70% of transmission ♦ Viral shedding occurs in 4-75% of days

6. Treatment of recurrent genital herpes ♦ Acyclovir - 200 mg five times a day ♦ Acyclovir - 400 mg three times a day ♦ Acyclovir - 800 mg two times a day ♦ Valacyclovir - 500 mg thrice a day ♦ Valacyclovir - 1000 mg twice a day ♦ Valacyclovir - 1000 mg once a day ♦ Famciclovir - 250 mg two times a day ( for 5-7 days or till complete healing) ♦ Famciclovir - 1000 mg 2 times a day X 1 day (patient initiated)

7. Acyclovir ♦ Safe but poor oral bioavailability (10-20%) ♦ Short plasma t ½  frequent dosing Valacyclovir ♦ Valine ester prodrug of acyclovir: readily absorbed  5 times greater bioavailability ♦ Headache : most common side-effect ( 14-35 %) ♦ ?? Thrombotic Microangiopathy (TMA) : Long term high dose therapy Famciclovir ♦ Diethyl ester form of penciclovir  Rapidly absorbed  greater bioavailability ♦ Safety profile comparable to acyclovir

8. Acyclovir, valacyclovir and famciclovir EQUALLY efficacious and safe in treatment of recurrent genital herpes Valacyclovir and famciclovir offer more convenient dosing regimens but expensive

9. Episodic treatment should start as early as possible since maximum viral replication occurs within 24 hours of the first prodrome symptom

10. We evaluated effectiveness and safety of oral acyclovir 1gm twice daily for 3 days in treatment of recurrent genital herpes

11. Patients’ profile No. of patients :22 Age range (mean) :18-55 yrs (28.95 ± 8.21) Male/female :20 : 2 Duration of disease : 0.1 to 204 months (mean 38.80 ± 50.56) No. of recur / yr : 1-48 (mean 11.45 ± 11.56)

12. Inclusion and exclusion criteria Inclusion: ♦ >16 years age, either sex with clinically active genital herpes Exclusion: ♦ Patients with severe renal, hepatic or heart disease ♦ Pregnant and lactating women ♦ Antiviral therapy within previous 14 days ♦ Immunosuppressed patients including transplant recipients on immunosuppressive drugs, HIV positive ♦ Known hypersensitivity to acyclovir ♦ Unwilling to consent for the study

13. Intervention and follow up Complete clinical and lab evaluation Acyclovir 1gm twice daily orally for 3 days Followed up on day 3, 5 and 7 ♦ Response to treatment – PGA, %age healing VAS ♦ Side effects – Clinical and Lab

14. Response to Treatment (Complete healing) Day No. of patients (%) 3: 09 (41%) 5: 17 (77%) 7 : 20 (91%)

15. Percentage healing of ulcer Day % of healing 3:77.95 ± 26.03 5:90.00 ± 16.20 7:95.00 ± 7.07 Mean healing time - 4.91 ± 2.16 (3 - 10 days) Median healing time - 5 days

16. Improvement in VAS Day No. of patients (%) 3 09 (40.91) 5 21 (95.45) 7 22 (100)

17. Percentage improvement in VAS Day Mean VAS Imp 3:80.45 ± 25.30 5 :97.69 ± 8.32 7:100 ± 0.00

18. Goldberg et al (JAAD 1986): n =157 ♦ Acyclovir 800 mg twice a day x 5 days ♦ Healing time : 5.2 days ♦ Acyclovir 200 mg five times a day x 5 days ♦ Healing time : 6.2 days Both regimens equally effective

19. Wald et al (2002): n = 84 ♦ Acyclovir 800 mg three times x 2 days ♦ Healing time: 4 days Shelley et al (Cutis 1996): n = 36 ♦ Acyclovir 800 mg “stat” at first signs/symptoms ♦ Prevented lesions in 81% (26/32) persons

20. Nilsen et al (Lancet 1982): ♦ Acyclovir 200 mg five times daily x 5 days ♦ Healing time : 5 days Our Study: ♦ Mean healing time - 4.91 ± 2.16 (3-10 days) ♦ Median healing time - 5 days

21. Conclusions ♦ Oral acyclovir in a dose of 1 gm BD x 3 days seems to be effective in the treatment of recurrent genital herpes ♦ Mean healing time : 4.9 days ♦ Median healing time - 5 days ♦ No significant side effects Oral acyclovir in high dose short course (1gm BD x 3d) regimen is effective and safe

23. Incredible India !!

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