CLJI Worldwide's VIBLOK Addresses Unmet Need in Prevention of Herpes Simplex Virus Transmission in Men and Women - Seite 2

In the absence of a cure, treatment of HSV-2 focuses on symptom relief once a genital lesion develops, reducing recurrent episodes of lesion development, and preventing viral transmission between sexual partners. Not only are genital lesions due to HSV-2 often very painful, they also increase the risk of acquiring and transmitting HIV. An HSV-2 seropositive individual is 2-3 times more likely to acquire HIV, while an HIV-infected individual is 3 times more likely to transmit HIV if they are also HSV-2 seropositive [2-8].

In addition to physical symptoms, STIs may cause psychological and psychosexual morbidity. Among some individuals with recurrent genital herpes, a range of emotional responses may be seen, including depression, anguish, distress, anger, diminution of self-esteem and hostility towards the person believed to be the source of infection [9].

"A number of individuals in the trial have shared the emotional distress they experience as a result of having HSV-2," explains Aletha Veenendaal, Principle Investigator at the EB Flevo clinical trial site in The Netherlands. "One trial participant burst into tears as she described her confusion and heartbreak when her ex-boyfriend, who denied giving her HSV-2, left her with recurrent outbreaks." Veenendaal continues, "Now, many years later, she hopes that something positive will come out of her experience."

Despite the use of medical treatments and condoms, genital herpes transmission may still occur through unprotected areas of the skin via micro-sized lesions, which are often exacerbated by grooming practices of the genital area, such as shaving and waxing [10]. Furthermore, while most people with HSV-2 are asymptomatic, viral shedding occurs even when symptoms are not present and can lead to HSV-2 transmission [3]. There is an immediate and growing need for STI prevention as more and more individuals are infected. In the United States, the CDC estimates that almost 20 million new STIs occur each year (50% among people aged 15-24 years old), accounting for nearly $16 billion in health care costs [11].

VIBLOK is an investigational device being evaluated in Europe and the outcomes of this clinical trial will be used to support the product application for CE Mark. It does not have an approved Investigational Device Exemption in the United States.

The SAFE Trial reflects just one of the pioneering studies, sponsored by CLJI Worldwide, that aims at investigating overlooked aspects of healthcare and subsequently solving real problems with scientifically and clinically proven products.