HerShield: Empowering Women Through Innovative Drug Delivery

Genital herpes is a lifelong infection affecting more than 500 million people worldwide. In the US alone, each year approximately one million people are newly diagnosed with herpes and $1 billion is spent on treatment. Individuals infected with herpes experience painful viral outbreaks along with significant psychological stress, social stigma, and anxiety. Current therapies suppress viral load to decrease the length and severity of symptoms, but they are not curative. Condoms, dental dams, and antiviral medication are all available prevention options, but are usually controlled by the partner with the infection, and proper use may not be negotiable or verifiable, especially as the herpes (HSV-2) virus can be transmitted even when one partner is not showing symptoms. A new self-controlled vaginal film called HerShield empowers people with vaginas to protect themselves against genital herpes.

Description

HerShield is a biodegradable film applied intra-vaginally that contains the antiviral drug tenofovir that has demonstrated activity against HSV-2 infection when used vaginally. HerShield does not require an applicator. It is both portable and discreet. HerShield is also environmentally-friendly and inexpensive. Two phase I clinical trials have demonstrated that the first generation prototype of HerShield is safe and delivers sufficient quantities of drug for protection from herpes infection. HerShield’s demonstrated ability to deliver antiviral medication indicates a potential to deliver antiretrovirals to protect against HIV; moreover, as HSV-2 infection increases the risk of HIV infection, its present application serves as a moderate preventative against HIV as well.

Applications

• Prevention of herpes
• Potential use with antiretrovirals to prevent HIV
• Delivery of probiotics and other agents for vaginal health

Advantages

• Self-controlled, allowing individuals to feel secure and take control over their own sexual health
• Portable, discreet, and less “messy” than water-based gels
• Biodegradable and non-toxic
• Affordable and accessible

Invention Readiness

Successful phase 1 clinical tests demonstrate effective antiviral drug delivery

IP Status

https://patents.google.com/patent/US20230346693A1

Related Publication(s)

Bunge, K. E., Dezzutti, C. S., Hendrix, C. W., Marzinke, M. A., Spiegel, H. M. L., Moncla, B. J., Schwartz, J. L., Meyn, L. A., Richardson‐Harman, N., Rohan, L. C., & Hillier, S. L. (2018). FAME-04: A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of film and gel formulations of tenofovir. Journal of the International AIDS Society, 21(8). https://doi.org/10.1002/jia2.25156

Robinson, J. A., Marzinke, M. A., Fuchs, E. J., Bakshi, R. P., Spiegel, H. M. L., Coleman, J. S., Rohan, L. C., & Hendrix, C. W. (2018). Comparison of the Pharmacokinetics and Pharmacodynamics of Single-Dose Tenofovir Vaginal Film and Gel Formulation (FAME 05). JAIDS Journal of Acquired Immune Deficiency Syndromes, 77(2), 175–182. https://doi.org/10.1097/qai.0000000000001587