INTRAVENOUS ACYCLOVIR TREATMENT FOR POSTHERPETIC NEURALGIA

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Postherpetic neuralgia (PHN) is a painful condition that occurs after resolution of herpes zoster rash (shingles). It occurs primarily in people over the age of 50. Symptoms, including persistent burning or lancinating pain and extreme skin sensitivity, may significantly affect their quality of life and lead to feelings of despair. Numerous treatments, including tricyclic antidepressants, anticonvulsants, and opioid narcotics, are often ineffective or have serious adverse side effects in elderly patients. Additionally, these treatment strategies are designed to relieve symptoms, not eliminate the cause of the pain. Although the mechanism of PHN is unknown, intriguing evidence has emerged suggesting that a persistent infection of varicella-zoster virus in sensory ganglia may lead to PHN. Therefore, aggressive treatment of PHN by antiviral drugs that inhibit viral replication should effectively relieve pain and improve quality of life. Patients enrolled in this study, after satisfying all inclusion and exclusion criteria, would be admitted to the GCRC for 14 days and treated with an intravenous infusion of acyclovir. While on the GCRC, patients would be monitored daily for any adverse effects of the treatment, including a basic metabolic panel measured every other day, and a CBC on day 9. Blood drawn on days 1, 5, 9 and 13 would also be used to assess the presence of VZV DNA in blood mononuclear cells using the polymerase chain reaction. Patients would be asked to fill out two questionnaires, the Pain Assessment Survey and the Short Form 36 Health Survey four times: at the beginning of the study, immediately after IV therapy, immediately after oral therapy, and four weeks following the end of treatment with oral valacyclovir. The Pain Assessment Survey consists of the Numeric Rating Scale for Pain, the Patient Global Impression of Change, and the Pain Description. Pain will be assessed using the Numeric Rating Scale for Pain, an 11-point scale with 0 representing no pain and 10 representing the worst pain ever experienced. Quality of life will be assessed using the Patient Global Impression of Change and the SF-36 Health Survey. The entire PAS takes less than 15 minutes to complete, and the SF-36 takes less than 10 minutes to complete. The primary endpoint is the change in NRSP score. The primary efficacy analysis will be based on the improvement or deterioration in the NRSP score between the first day of treatment and four weeks after completion of the oral valacyclovir regimen. The secondary end points are improvement in pain measured by the Patient Global Impression of Change scale and quality of life as measured by the SF-36 Health Survey. Improvement will be measured by the difference in scores on the first day of treatment, after IV therapy, after oral therapy, and four weeks following completion of the oral valacyclovir treatment.