盐酸缬更昔洛韦片最常见不良反应

The tablet is the L-valyl ester (prodrug) of ganciclovir, which is rapidly converted into ganciclovir by esterases in the small intestine and liver after oral administration. Valganciclovir hydrochloride tablets are a synthetic 2’-deoxyguanylate analogue that inhibits herpes virus replication in vitro and in vivo. What are the most common adverse reactions of Valganciclovir Hydrochloride Tablets?

(1) Treatment of CMV retinitis in AIDS patients: In a clinical trial in which 79 patients in each group were randomly treated with valganciclovir or intravenous ganciclovir for 28 days (21 days of induction treatment, 7 days of maintenance treatment), the safety data of the two groups were comparable. The most frequently reported adverse events were diarrhea, neutropenia, and pyrexia. Diarrhea, oral candida infection, headache, and fatigue were more commonly reported in the oral valganciclovir group, whereas nausea and injection site-related events were more commonly reported in the intravenous ganciclovir group. Across both clinical trials (n=370), the most commonly reported adverse events (% of patients) in the Vancevir treatment group, regardless of severity and whether drug-related, were diarrhea (38%), pyrexia (26%), nausea (25%), neutropenia (24%), and anemia (22%). Most adverse events were mild or moderate. Regardless of severity, the most common events reported by investigators to be related (including possibly unrelated, possibly related, and probably related) to vasevir were neutropenia (21%), anemia (14%), diarrhea (13%), and nausea (9%).

(2) Prevention of CMV infection in organ transplant patients: The adverse reaction data are from a clinical trial. Solid organ transplant patients received valganciclovir (n=244) or oral ganciclovir (n=126), starting within 10 days after transplantation, until 100 days after transplantation, and observed until 28 days after drug withdrawal. Regardless of severity and whether drug-related, the most frequently reported adverse events (% of patients) in the valganciclovir treatment group (n=244) in this clinical trial were diarrhea (30%), tremor (28%), and graft rejection (24%), nausea (23%), headache (22%), leg edema (21%), constipation (20%), back pain (20%), insomnia (20%), hypertension (18%), and vomiting (16%). These adverse events were also seen in patients taking oral ganciclovir with similar rates. Most adverse events were mild to moderate.