Great advancements have been made in recent years towards the treatment and prevention of HIV/AIDS, which currently affects over 35 million people globally, according to data from the WHO. While rates of infection have been declining due to advancements in technology and increased access to healthcare and education, upwards of 70% of those affected live in Sub-Saharan Africa. Condom use is still low in the region, but the importance of safe sex and prevention is taking hold. A recently developed product, if brought to the continent, could be a valuable tool in the fight against the disease.
An Australian-based biotech firm has unveiled an antiviral compound, capable of destroying and deactivating up to 99.9% of HIV, Herpes, and other sexually-transmitted viruses, and hopes to have the product on the shelves in the coming months. Starpharma Holdings Ltd., based in Melbourne, has been working on it since at least 2008. The firm is finally ready to team up with one of the world’s largest condom makers, Ansell (maker of Lifestyles condoms), to bring to market a condom that can not only act as a barrier to STIs but can essentially kill them on contact. The product is called VivaGel, and it is composed of 0.5% astrodimer sodium, which is a non-antibiotic, antimicrobial gel. The astrodimer is part of the dendrimer family, which is a nano-scale molecule that binds to viruses and prevents them from affecting an organism’s cells. Starpharma employs dendrimer technology in a number of its other products. It was originally developed as a vaginal microbicide for treatment of genital herpes, HIV and STIs, including human papillomavirus (HPV), which is the “causative agent of cervical cancer.”
According to Dr. Jackie Fairley, CEO and Executive Director at Starpharma, VivaGel works by reducing the number of virus particles, by inactivating them. This then reduces the overall viral load, which reduces the risk of potential infection. The gel will be mixed with lubricant and will be marketed as a condom branded as “Lifestyles Dual Protect”. Dr. Fairly stated that the biotech firm has no current plans to sell VivaGel as a “stand-alone product.”
The substance has undergone myriad lab test and clinical trials throughout the course of its development. VivaGel has been approved by Australian regulators, and has recently gained Conformity Assessment Certification from Australia’s Therapeutic Goods Administration (TGA), which is similar to the FDA in the USA or the CE Mark in the EU. Passing this key step in the regulatory process means that the product is likely to be on the market within months. The final step is to have the product listed on the Australian Register of Therapeutic Goods (ARTG). In anticipation of this final step, Starpharma has entered into a licensing agreement with Ansell and Okamoto, a leading condom producer in Japan. Japan is the world’s second largest condom market in the world, and will be a secondary location for the production and sale of VivaGel once it is set for market.
Starpharma has received a number of research grants to support the development of VivaGel. Initially it was externally funded from the development stage through to clinical trials, and was licensed to SSL International PC (Durex) in 2008. At that time, development was also supported through public funding for HIV research. Since 2012, the USA has been interested in the product, and is supporting clinical trials that involve the product in the treatment of bacterial vaginosis, a common infection that increases a woman’s susceptibility to contracting an STI/STD. The National Institute of Health (NIH) and the National Institute of Allergy and Infectious Disease (NIAID) in the USA have jointly contributed $20.3 million dollars toward the project. The funds have been supported by the Australian government’s $100 million Pharmaceutical Partnerships Program, which has contributed about 8 million toward the project as of last year. Starpharma will work alongside the NIH and NIAID under a collaborative research agreement, with teams of internationally recognized leaders in HIV/AIDS treatment and prevention methods. Others involved in the partnership include the Burnet Institute (Australia), the National Centre for HIV Epidemiology and Clinical Research (University of New South Wales), and the Thai Red Cross AIDS Research Centre.
Though VivaGel is not yet on the shelves, and plans have not been set to disperse the product across the Global South, the potential impact that the product and others like it that may follow is still apparent. It is indicative of the advancements in current research and technology. The fact that these condoms are capable of deactivating these viruses on contact might help to increase condom use in Sub-Saharan Africa and other regions, where faith in contraceptives is low. For now, we will follow the development of the product, and will continue with updates once it hits the market.
For more on Starpharma, and VivaGel, see their website, or watch this short PowerPoint presentation outlining the development and purpose of VivaGel. Click here for more articles about innovations in the fight against HIV/AIDS.