Delivering for Women's Health in 2015
A message from Dr. Zeda F. Rosenberg, IPM's CEO
Advances against HIV/AIDS last year gave us many reasons to celebrate. For the first time in the epidemic, more people were put on treatment than were newly infected. AIDS-related deaths declined worldwide at the same time that access to treatment as well as prevention options like voluntary medical male circumcision and pre-exposure prophylaxis (PrEP) expanded.
As we applaud these successes, we must amplify our response to the progress yet to be made for women and girls, who remain at a disproportionate — and alarmingly high — risk of HIV infection. In some parts of the world, young women ages 15 to 24 are more than twice as likely to be infected with HIV as men their age. It is that reality that continues to drive our work here at IPM.
And it is our hope that the most clinically advanced vaginal microbicides — tenofovir gel and IPM’s monthly dapivirine ring — could soon be the world’s first effective women-initiated, antiretroviral (ARV)-based HIV prevention products. Early this year, we will know whether tenofovir gel, designed to be used around the time of sex, is effective in the FACTS 001 trial. We will know by 2016 whether the long-acting dapivirine ring prevents HIV in women. The ring is in parallel Phase III trials: IPM’s Ring Study and the ASPIRE study, being conducted by our partner the Microbicide Trials Network (MTN). Both trials reached full enrollment last year.
Because it can take several years to get an effective product into women’s hands, our work to integrate the dapivirine ring into the broader HIV prevention toolkit has already begun. In 2015, we will continue working with regulatory agencies across Africa to meet country-specific regulatory requirements as we finalize manufacturing plans for potential scale-up to ensure affordable and widespread access to the ring. IPM is also planning future studies to give women in the current Phase III ring studies early access to the product pending its approval; and engaging partners, advocates and health workers to help shape plans for possible roll-out.
A focus on research and development — a key strategy to ending AIDS — rightfully holds a place in the post-2015 agenda. In the HIV prevention field, this means we must build on our accomplishments by continuing to develop a diverse range of technologies that can both outsmart the evolving HIV virus, and respond to women’s individual sexual and reproductive health needs. In 2015, IPM will see two of its products begin first-in-human clinical trials in the United States: Planned for Q3 is a trial of a vaginal formulation that contains DS003, a novel ARV that may help reduce the risk of acquiring drug-resistant HIV. A trial of our 90-day dapivirine-contraceptive ring designed to simultaneously protect against HIV and unintended pregnancy, is set to begin in Q4. We are also proud to support the development of rectal microbicides for both women and men by providing IPM-licensed compounds for clinical trials to be led by MTN and the University of Pittsburgh this year.
Our shared vision for women’s broader HIV prevention and reproductive health in 2015 and beyond is within reach. The inaugural HIV Research for Prevention (R4P) Conference in Cape Town this past fall saw promising developments in multipurpose prevention technologies as well as efforts to scale up existing HIV prevention tools that could benefit women, such as PrEP. We are encouraged by renewed calls for the proposed Sustainable Development Goals to meet women’s fundamental needs, including access to life-saving family planning services and gender equality. We must deliver on these global commitments to ensure that women and girls everywhere have a chance at a healthy future.
IPM is honored to work with partners who share our dedication to improving the well-being of women, their families and their communities. Thank you for continuing to be a champion for HIV prevention, and for women’s sexual and reproductive health and rights. I wish you a healthy, happy and rewarding 2015.