Planning for future milestones to expand
Any strategy to slow, and ultimately end, the epidemic must include a diverse prevention pipeline that addresses women’s comprehensive sexual and reproductive health needs. Using the dapivirine ring as a platform technology, IPM is steadily advancing a range of promising next-generation products that could offer women more effective and convenient tools to protect their health.
In 2016, IPM and MTN prepared for a Phase I study of IPM’s three-month dapivirine-only ring that would offer women longer-lasting protection. The study is planned for 2017 and will evaluate the safety and pharmacokinetics of rings with different doses of dapivirine.
IPM and MTN also planned for a Phase I trial of IPM’s three-month dapivirine-contraceptive ring that is designed to prevent HIV and unintended pregnancy, two leading contributors to death and disability among women of reproductive age. Initiated in 2017, the trial is assessing the ring’s safety and pharmacokinetics and includes the three-month dapivirine-only ring for comparison. Results from both Phase I studies will inform next steps for the dapivirine-contraceptive ring and help define the possible regulatory pathway for the three-month dapivirine-only ring.
Under agreements with leading pharmaceutical companies, IPM is also exploring products that would combine the potency of different ARVs with mechanisms of action that have not been used for prevention. Introducing new routes of attack and disabling the virus in multiple ways in a single product could help reduce the chance of acquiring drug-resistant HIV and improve the product’s overall effectiveness.
Data analysis began in 2016 for a Phase I safety and tolerability trial of a vaginal tablet containing DS003, a gp120 entry inhibitor licensed from Bristol-Myers Squibb. Results are expected in 2017 and will inform the development of a DS003-dapivirine vaginal ring. In addition, IPM is planning analytical and preformulation studies of darunavir — a protease inhibitor licensed from Janssen that is currently used for HIV treatment — to inform future prototypes of a darunavir-dapivirine vaginal ring.
“HIV infection cannot be undone or reversed. The ring can save their lives. The ring can give young women back some power. The ring could become an important arsenal in the fight against HIV among young women, so I'll be keeping my eye and ear close to its further development. The ring has in me a new advocate!”
– Gqibelo Dandala, chief executive officer, Future of the African Daughter
“We need new prevention tools if we are to escape this epidemic. Investment in research and development for new prevention tools remains a critical goal for us all.”
– Naledi Pandor, minister of science and technology of South Africa