These studies suggest that the glycoprotein D vaccine has efficacy against genital herpes in women who are seronegative for both HSV-1 and HSV-2 at base line but not in those who are seropositive for HSV-1 and seronegative for HSV-2. It had no efficacy in men, regardless of their HSV serologic status.

Once-daily suppressive therapy with valacyclovir significantly reduces the risk of transmission of genital herpes among heterosexual, HSV-2-discordant couples.

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Prevention of sexually transmitted infections is a priority in developed and developing countries. One approach to prevention is the use of topical microbicides, and one promising approach is the use of dendrimers, highly branched macromolecules synthesized from a polyfunctional core. Three new dendrimer products developed to provide stable and cost-efficient microbicides were initially evaluated in vitro for anti-herpes simplex virus activity and then in vivo by using a mouse model of genital herpes. From these experiments one product, SPL7013, was chosen for further evaluation to define the dose and duration of protection. Unformulated SPL7013 provided significant protection from genital herpes disease and infection at concentrations as low as 1 mg/ml and for at least 1 h following topical (intravaginal) administration of 10 mg/ml. This compound was then formulated into three vehicles and further evaluated in mouse and guinea pig models of genital herpes infection. In the murine evaluations each of the formulations provided significant protection at concentrations of 10 and 50 mg/ml. Formulated compounds provided protection for at least 1 h at a concentration of 10 mg/ml. From these experiments formulation 2V was chosen for dose ranging experiments using the guinea pig model of genital herpes. The guinea pig evaluations suggested that doses of 30 to 50 mg/ml were required for optimal protection. From these studies a lead compound and formulation (2V of SPL7013) was chosen for ongoing evaluations in primate models of simian immunodeficiency virus and Chlamydia trachomatis infection.

Current therapies available for the treatment of chronic hepatitis B are limited in their ability to result in a cure. Clevudine is a new pyrimidine analog with potent anti-hepatitis B virus (HBV) activity in vitro. A multicenter dose-escalation study evaluated clevudine at 10, 50, 100, and 200 mg once daily for 28 days. Eligible patients had HBV DNA levels of 3 ؋ 10 6 copies/mL or more, had not undergone nucleoside treatment, and were without human immunodeficiency or hepatitis C virus coinfection. Thirty-two patients were enrolled (5, 10, 10, and 7 patients in the 10-, 50-, 100-, and 200-mg dose groups, respectively), 81% were male, 81% Asian, and 88% were hepatitis Be antigen (HBeAg) positive at baseline. Median pretreatment serum HBV DNA levels ranged from 7.3 to 8.8 log 10 copies/mL. After 28 days, the median HBV DNA log 10 change from baseline was ؊2.5, ؊2.7, ؊3.0, and ؊2.6 log 10 . Six months after dosing, median changes from baseline were ؊1.2, ؊1.4, ؊2.7 and ؊1. H epatitis B virus (HBV) can lead to chronic hepatitis and cirrhosis with 350 million carriers worldwide. 1 Currently approved antiviral regimens have been shown to improve the short-term outcome of the disease in some patients; however, they lack the ability to provide a cure or durable remission in most patients who are chronically infected with HBV. 1 Currently approved drugs include interferon, lamivudine, and adefovir. Interferon can be administered only subcutaneously and is associated with frequent side effects. Lamivudine is an oral drug with a favorable safety profile; however, long-term therapy is required with this drug, which leads to the selection of drug-resistant mutants. 2 Adefovir is another oral drug that also requires long-term therapy. It has been shown to select for resistant mutants in a very limited proportion of patients. 3 Therefore, there is a need for developing new agents for the treatment of HBV infection with improved efficacy.Clevudine [1-(2-deoxy-2-fluoro-␤-L-arabinofuranosyl) thymine] is a nucleoside analog of the unnatural ␤-L configuration. Clevudine has potent activity against HBV and some activity against Epstein-Barr virus in vitro. 4,5 The 50% effective concentration for HBV inhibition values ranged from 0.02 M to 0.84 M in a variety of systems used to evaluate the inhibitory effect of clevudine on wild-type HBV. These values are comparable with From the

These findings suggest that the immunological control of HSV-2 reactivation and lesion clearance may differ and that TLR7 and TLR8 agonists can reduce the frequency of mucosal HSV-2 reactivation.

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