jc-1 (1).pptx Efficacy of valacyclovir and famciclovir in herpes zoster: A comparative study

Efficacy of valacyclovir and famciclovir in herpes zoster: A comparative study

1. Efficacy of valacyclovir and famciclovir in herpes zoster: A comparative study Ankita Bist , A. Savitha, Kashinath M. Gumma Indian J Pharmacol 2020;52:472-5 Presenter: Dr.Arpitha R

2. ABSTRACT OBJECTIVES: The objective was to evaluate the efficacy of antiviral agent valacyclovir compared with famciclovir in the treatment of herpes zoster. MATERIALS AND METHODS: A comparative study was conducted over a period of 1 year. Data relevant to the study were collected from 60 patients, with active herpes zoster presenting to the outpatient department within 72 hr of the first occurrence of zoster rash. They were divided in to two groups of 30 patients each. The first group of patients received valacyclovir tablet 1000 mg thrice daily, whereas those in the second group were given famciclovir tablet 500 mg thrice daily. Both the drugs were given for 7 days. Periodic follow‑up till 29th day was done for assessment of the effects of given drugs. RESULTS : Significant decrease was observed on comparison of pain scores between the two groups using the visual analog scale, with the drug valacyclovir, than in the famciclovir group at day 29. Furthermore, valacyclovir treatment accelerated the resolution of zoster associated pain in more number of patients compared with famciclovir. CONCLUSION : Oral valacyclovir administered during acute zoster infection for a period of 7 days offers significant benefit compared to famciclovir by providing a well tolerated and greater resolution of pain while maintaining the favorable safety profile, making valacyclovir more efficacious and a better drug in management of Herpes Zoster in comparison to famciclovir. Keywords: Famciclovir, herpes zoster, valacyclovir

3. Introduction Herpes zoster a localized disease also known as varicella zoster and shingles is typically characterized by unilateral radicular pain along with grouped vesicular eruptions. The pharmacotherapy for its management comprises antiviral agents, analgesics, and corticosteroids Valacyclovir accelerates resolution of acute pain associated with herpes zoster and also decreases number of patients complaining of persistent pain.

4. Famciclovir is another antiviral agent, which is a prodrug of penciclovir available with the advantage of a longer intracellular half‑live and a better bioavailability. However, still, there is a paucity of clinical studies comparing the effects of valacyclovir and famciclovir in the literature available and hence, the present study has been undertaken

5. Materials and methods Study population: Patients with herpes zoster Study period : One year Study site: Outpatient department (OPD) of Dermatology at BRIMS, Bidar, Karnataka. Data collection was done by recording patient’s details in a preformed performa , after taking written informed consent from the patients. Individual parameters including demographic details, history of presenting illness, symptoms and signs were recorded.

6. Inclusion criteria Patients of any gender aged above 18 years, with clinically confirmed diagnosis of herpes zoster; new, untreated cases who presented within 3 days of appearance of zoster associated rash.

7. Exclusion criteria Patients with atypical presentations Patients with associated complications Pregnant and lactating females Patients with known immunocompromised status Those treated with other antiviral agents and immunomodulatory drugs Patients with preexisting hepatic or renal impairment Noncompliant and dropout patients were also excluded from the study.

8. It was an analytical observational cohort study ; universal sampling technique was applied. The sample size was calculated as per the average number of active herpes zoster patients, attending the OPD of dermatology during the period of study. A total of 60 patients, two groups of 30 patients each, were enrolled in the study.

9. Patients presenting on the 1st month were prescribed valacyclovir 1000 mg thrice daily, and those presenting on the 2nd month were prescribed famciclovir 500 mg thrice daily. The treatment was given for 7 days . The same alternating drug method was followed for the rest of the 10 months during the study period Valacyclovir or famciclovir for 7 days was given to patients of these groups, respectively. Rationale? Formulation ? With/ without food

10. To maintain the efficacy of drugs, the same brand drugs were used throughout the study duration. Forty milligrams methyl prednisone once daily in the morning for 1 week from the presentation, followed by tapering over the next 2 weeks was added to all the patients. Acetaminophen 500 mg TDS was also added for 1st week, followed by as and when required. Formulation?

11. Follow‑up was done on days 3, 8, 15, 22 and 29. Patients were requested to visit in the morning without taking prior medication on the day of follow‑up. For assessment of the compliance, the pill counting method was applied; patients were asked to bring the drug strip in every scheduled visit , so as to check the number of remaining pills in the pack. Rationale?

12. Statistical analysis Statistical analysis was conducted using GraphPad Software, 2365 Northside Dr.Suite 560, San Diego, CA 92108. Assessment of the intensity of pain was done using the visual analog scale  (VAS). It is a numerical rating scale that shows markings ranging from 0 to 10 that represents a continuum; in the increasing order of severity from no to worst pain.

13. The reduction in pain scores between both the groups was analyzed using unpaired t‑test. The rate of pain cessation, i.e., the proportion of patients without pain was compared using the Chi‑square test between the two groups after every visit. P < 0.05 was considered to be statistically significant in both the tests.

14. Ethical considerations The study was done after obtaining clearance from the Institutional Ethical Committee of Bidar Institute of Medical Sciences, Bidar. No. BRIMS/Ethical Committee: BRIMS/IEC/46/2015. IEC No.: IRB 84/2015.

15. Results

16. Discussion When given within 3 days of the appearance of the first lesion, both valacyclovir and famciclovir provide a reduction in duration not only loss of acute pain but also of full crusting and healing of the zoster associated lesions Both were well tolerated with no serious adverse effects

17. Better reduction of pain with valacyclovir treatment was observed, which was found to be statistically significant only on day 29 (P = 0.005). Although valacyclovir provided a faster resolution of pain, and more number of pain free patients by day 29, the difference in number of pain free patients was not statistically significant when compared with famciclovir (P = 0.1590).

18. Valacyclovir, by its virtue of reducing the severity of pain significantly, can be said to have a favorable effect on the development of postherpetic neuralgia. Similar findings were reported by Indradevi et al. at a study conducted in a tertiary care hospital in Puducherry and also by Tyring et al.in their study in the United States.

19. Conclusion Oral valacyclovir administered during acute zoster infection for a period of 7 days offers a significant benefit by its virtue of providing a greater resolution of pain along with good tolerance compared to famciclovir while maintaining the favorable safety profile.

20. References Strauss SE, Oxman  MN, Schmader  KE. Varicella and herpes zoster. In: Wolff K, Goldsmith LA, Katz SI, Gilchrest BA, Paller  AS, Leffell  DJ, editors. Fitzpatrick’s Dermatology in General Medicine. 7th ed.. New York: Mc Graw Hill Publishing Division; 2008. p. 1885‑98. Kawai K, Gebremeskel  BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: Towards a global perspective. BMJ Open 2014;4:e004833. Thomas SL, Hall AJ. What does epidemiology tell us about risk factors for herpes zoster? Lancet Infect Dis 2004;4:26‑33. Wareham DW, Breuer J. Herpes zoster. BMJ 2007;334:1211‑5.

21. Strengths of the study None

22. Limitations of the study- author Antivirals not given exclusively; due to severity of pain, analgesics and corticosteroids had to be added. Some patients required an added dose of pregabalin 75 mg BD depending on the pain severity, thus increasing the chances of error. The study sample size was restricted by number of patients presenting to the hospital over the duration of the study. Some patients still confirmed taking pain relief medication on day of follow‑up

23. Limitations of the study- observed Title of the study Randomization / CONSORT Small sample size Formulation of the drugs not mentioned Pill count method Concomitant medications Rationale for treatment / follow-up

24. Objectives of the study not mentioned Primary or secondary end points not mentioned Not generalizable Baseline characteristics not mentioned Grammatical errors/ spelling mistakes Adverse effects not mentioned in the form of text or tabular column

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