Viral prophylaxis treatment methods and pre-exposure prophylaxis kits

Abstract

The present disclosure provides compositions and methods for the prevention of HSV infection in an HSV seronegative individual.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application No. 62 / 021,589 filed Jul. 7, 2014, which is incorporated by reference herein in its entirety.BACKGROUND OF THE INVENTION[0002]Herpes simplex virus (HSV) causes life-long viral disease in those infected and there is currently no cure. HSV infection typically leads to establishment of latent viral infection in nerve cells, with consequences of this infection covering a spectrum from no symptoms to repeated and / or severe episodes of active form of the disease. Active forms of the disease can manifest as cold sores and / or genital herpes.[0003]Worldwide, there are over 500 million people infected with HSV type 2 (HIV-2), with an estimated 23 million new infections annually. It has been estimated by the Centers for Disease Control and Prevention that in the United States alone in 2008, 16 percent of the population was infected with HSV-2 and in excess of 90% of U.S. citizens we...

AI Technical Summary

Benefits of technology

[0007]Clinical treatment of HSV has shifted from focusing on acute treatment of symptomatic outbreaks (e.g., treatment of lesions) to reducing the frequency of symptomatic outbreaks, thus reducing the viremia and amount of viral shedding in the seropositive individual. This has led to the development of suppressive therapy, in which the seropositive individual attempts to maintain a low-level concentration of an HSV antiviral drug in the bloodstream so that the number of outbreaks is potentially reduced, and to reduce viral shedding, potentially lowering the risk of transmission. However, suppressive treatment with antiviral drugs does not completely eliminate all viral shedding, providing a possible transmission pathway for infection of seronegative individuals.

[0027]In some embodiments, the subject is exposed to HSV from the HSV seropositive partner during physical contact. In some embodiments, the administered composition suppresses HSV replication in the subject. In some embodiments, the administered composition suppresses HSV activation in the subject. In some embodiments, the administered composition reduces the risk of HSV infection in the subject. In some embodiments, the risk of HSV infection in the subject is reduced by at least about 50%, 60%, 70%, 80%, 90% or 95%.

[0045]In some embodiments, the subject is exposed to HSV from the HSV seropositive partner during physical contact. In some embodiments, the administered composition suppresses HSV replication in the subject. In some embodiments, the administered composition suppresses HSV activation in the subject. In some embodiments, the administered composition reduces the risk of HSV infection in the subject. In some embodiments, the risk of HSV infection in the subject is reduced by at least about 50%, 60%, 70%, 80%, 90%, or 95%.

Problems solved by technology

Herpes simplex virus (HSV) is associated in many infected individuals with recurrences that manifest themselves as cold sores and / or genital herpes, both of which are often painful and embarrassing.

However, suppressive treatment with antiviral drugs does not completely eliminate all viral shedding, providing a possible transmission pathway for infection of seronegative individuals.