万赛维治疗效果如何？

It is an antiviral drug used to treat patients with acquired immunodeficiency syndrome (AIDS) combined with cytomegalovirus (CMV) retinitis, and to prevent CMV infection in high-risk solid organ transplant patients. On August 11, 2010, the U.S. Food and Drug Administration (FDA) approved the increased use of Vancevir in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

How effective is the treatment with Vancevi?

A double-blind, double-dummy active-controlled clinical trial was conducted in high-risk patients with CMV susceptibility (D+/R-) after heart, liver, and kidney transplantation. The patients started taking valganciclovir hydrochloride tablets (900 mg once a day) or oral ganciclovir (1000 mg three times a day) within 10 days after transplantation until 100 days after transplantation.

CMV infection as judged by the research efficacy committee includes CMV syndrome and tissue-infiltrating infection. The incidence of CMV infection within 6 months after transplantation was 12.1% in the valganciclovir hydrochloride tablets group (n=239) and 15.2% in the oral ganciclovir group (n=125). Most CMV infection cases occurred later in the valganciclovir hydrochloride tablets group after stopping preventive treatment (after 100 days) than in the ganciclovir group.

The incidence of acute rejection within 6 months after transplantation was 29.7% in the valganciclovir hydrochloride tablets group and 36.0% in the oral ganciclovir group (n=125).

A double-blind placebo-controlled trial was conducted on 326 high-risk patients with CMV susceptibility (D+/R-) after kidney transplantation to evaluate the efficacy and safety of this product in preventing CMV from 100 days to 200 days after transplantation. Patients were randomly divided into 1:1 groups. One group received this product (900 mg, once a day) from 10 days to 200 days after transplantation, and the other group received this product (900 mg, once a day) from 10 days to 100 days after transplantation, followed by placebo treatment for 100 days.

Studies extending the prophylactic treatment of CMV with this product until 200 days after transplantation confirmed that the 200-day dosing regimen is better than the 100-day dosing regimen in preventing CMV infection in high-risk kidney transplant patients during the first 12 months after transplantation. Proportion of patients developing CMV infection in the first 12 months after transplantation.

Patients were assumed to have CMV infection if there was no week 52 assessment or if CMV infection was not confirmed before this time point.

The graft survival rate at 12 months after transplantation was 98.2% (160/163) for the 100-day dosing regimen and 98.1% (152/155) for the 200-day dosing regimen. The incidence of biopsy-confirmed acute rejection 12 months after transplantation was 17.2% (28/163) for the 100-day dosing regimen and 11.0% (17/155) for the 200-day dosing regimen.

Judging from the above research data, the treatment effect is very good.