盐酸缬更昔洛韦片治疗CMV视网膜炎疗效如何？

It is the L-valyl ester (prodrug) of ganciclovir. After oral administration, it is rapidly converted into ganciclovir by esterases in the small intestine and liver. Ganciclovir is a synthetic analog of 2’-deoxyguanosine that inhibits herpes virus replication in vitro and in vivo.

In May 2001, the US FDA approved the listing of Valganciclovir Hydrochloride Tablets for clinical use in the treatment of acute retinitis caused by CMV infection in patients with acquired immunodeficiency syndrome. In May 2003, its indications were expanded. Valganciclovir Hydrochloride Tablets are used to prevent and treat secondary CMV infection in organ transplant recipients. On August 11, 2010, Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved valganciclovir hydrochloride tablets for the treatment of adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

The antiviral effect of valganciclovir hydrochloride tablets has been clinically confirmed by treating AIDS patients with newly diagnosed retinitis (clinical study WV15376). After 4 weeks of treatment with valganciclovir hydrochloride tablets, the detection rate of CMV virus decreased from 46% (32/69) to 7% (4/55). 

Clinical studies of valganciclovir hydrochloride tablets in AIDS patients infected with CMV retinitis have shown that valganciclovir hydrochloride tablets and intravenous ganciclovir are equally effective in the induction treatment of CMV retinitis.

In the study, patients with newly diagnosed CMV retinitis were randomly assigned to the valganciclovir hydrochloride tablet group or the intravenous ganciclovir group for induction therapy. The proportion of patients with progression of CMV retinitis at week 4 was the same in both groups. After induction therapy, both groups of patients in the study continued to receive maintenance therapy with valganciclovir hydrochloride tablets 900 mg per day.

The mean (median) time from randomization to progression of CMV retinitis was 226 (160) days and 219 (125) days in patients who received induction or intravenous ganciclovir followed by maintenance therapy with valganciclovir hydrochloride tablets, respectively.