Bhosale V., Jindal K., Tolat S., Kura M., Udare S., kulakarni V., Shah B., Raval R., & Marfatia Y. (2010). Comparative Study of the Efficacy and Safety of Acyclovir 1200mg Sustained Release Versus Acyclovir 800mg-Immediate Release in Immunocompetent Patients with Uncomplicated Herpes Zoster, The Indian Practitioner,  63, 759.

ABSTRACT 

To overcome the problem of poor compliance and to improve treatment outcome, a new sustained release formulation of Acyclovir 1200 mg has been developed. This drug was tested in multicentric, prospective, randomized, open label, active controlled, parallel group study in which the efficacy and safety of Acyclovir 1200 mg sustained release (SR) administered three times daily was compared with Acyclovir 800 mg five times a day for treatment of uncomplicated herpes zoster in immunocompetent adults. Total 112 patients suffering from herpes zoster were enrolled into the study at eight sites all over India and were administered either test or reference product as per the randomization schedule. Among that 22 subject were dropped out or withdrawn from the study so 90 subjects completed the clinical phase of the study. Treatment was initiated within 72 hours of onset of zoster rash and was continued for 7 days. In statistical analysis of primary variable i.e. proportion of patients who reached healing of 100% lesions on day 8(Visit-3), 15 (Visit-4), 22 (Visit-5) and 29 (Visit-6), post dosing shows no significant difference in rate of a healing of 100% lesions between test and reference product (p>0.05 level of significance, fisher exact test). Patients proportion of 100% loss of pain is 71.74% and 63.64% for test product and reference product respectively Test product is equally effective as reference product in showing 100% loss of pain on study completion (p=0.6761 > 5% level of significance, Chi-Square test). In conclusion, test product Acyclovir 1200 mg Sustained Release Tablets was found as effective and safe as reference product Acyclovir 800 mg Immediate Release Tablets in treatment of immunocompetent patients with uncomplicated Herpes Zoster.