A statistically significant reduction in Viracept-associated diarrhea through a step-wise dietary and pharmacological intervention program was reported. The study was conducted in association with the Sunnybrook and Women's College Health Sciences Centre in Toronto and Agouron Pharmaceuticals Canada Inc, a Pfizer Company.
An interim analysis of a study that investigated the effectiveness of a step-wise dietary and pharmacological intervention on the management of diarrhea associated with Viracept (nelfinavir mesylate) was presented. This study, which consisted of nutritional counseling, psyllium, calcium carbonate and loperamide, examined the daily bowel movement frequency, daily stool form scores, incontinence and urgency incidence, and self-reported quality of life ratings.
The results indicated that among 18 study patients, mean daily bowel movement frequency decreased by 32 percent, and mean daily stool form scores improved by 44 percent, representing an overall shift in consistency from loose to semi-/well-formed stools. Furthermore, incontinence and urgency incidence were reduced respectively from 5/18 to 1/18 patients and 6/18 to 1/18, and quality of life ratings related to both gastrointestinal disturbance and overall physical/psychosocial function generally improved.
The step-wise intervention method included bi-weekly reviews and adjustments, maintenance of a daily diary to record bowel movement frequency, urgency, incontinence, and stool-form consistency. Self-reported quality of life changes were measured using questions adapted from gastrointestinal (IBS-QOL), HIV-specific (HAT-QOL) and generic instruments (MOS SF-36). At baseline, patients in this study had a mean duration of 33 months (2.75 years) on Viracept, mean CD4 count of 554 cells/mm3, and 89 percent of patients had an undetectable viral load (<50 copies/mL).
"Diarrhea is a common side effect of antiretroviral therapy among patients with HIV. While most often manageable and mild, it can impact quality of life for some," said Dr. Rachlis. "Our interim analysis indicates clinically and statistically significant reductions in incidence with our algorithm, as well as an enhanced quality of life, which is particularly promising for those taking or considering Viracept."
The recommended dosage for Viracept is 1,250 mg [two 625 mg tablets (US) or five 250 mg tablets] twice daily or 750 mg (three 250 mg tablets) three times daily. It is recommended that Viracept should be taken with a meal when used in combination with other antiretroviral agents.