The Population Council, in collaboration with Oak Crest Institute of Science, is developing a three-month intravaginal ring (IVR) to prevent unintended pregnancy and HIV.
HIV continues to be a global health crisis, with over 1.5 million people newly infected every year. Sub-Saharan Africa accounts for over two-thirds of all global HIV infections, with women and girls shouldering a disproportionate burden (63%) of all new HIV infections in 2020. In addition, 40% of all pregnancies—85 million pregnancies a year—are unintended.
There is a significant unmet need for multipurpose prevention technology (MPT) products that protect women against HIV and/or unintended pregnancy. Although several MPTs are in development, the current pipeline is dominated by antiretroviral (ARV) products with progestin-only contraception using levonorgestrel. To expand the HIV prevention landscape, more easy-to-use, non-ARV, self-administered products are urgently needed.
The Population Council is developing a three-month, pod-type intravaginal ring containing the progestin etonogestrel (ETG), the estrogen ethinyl estradiol (EE), and the anti-HIV lectin QGriffithsin (QGRFT)—the EEQ IVR—to prevent unintended pregnancy and HIV. This product offers a highly effective contraceptive combination with QGRFT, which is a naturally occurring algae-derived protein that inhibits HIV and is the most potent anti-HIV agent described in the literature. QGRFT is not an anti-retroviral (ARV) drug, which means that its prolonged use should not provoke resistance in users to ARVs.
The EEQ IVR is currently in the preclinical phase of development. In conjunction with the EEQ IVR development work, a three-month pilot crossover clinical study is currently underway with 24 US couples. The study compares adherence, preference, and acceptability of three non-medicated silicone intravaginal rings (IVRs). These IVRs, each used for 30 days, have the same cross-sectional diameter but different outer diameters. The outcomes of this trial will inform the size of the EEQ IVR. This trial is being performed with the Albert Einstein College of Medicine and Emory University.
The EEQ IVR offers significant advantages over ARV and progestin-only contraceptive products. It could reduce both the emergence of drug-resistant HIV and common irregular bleeding complaints associated with use of progestin-only contraceptives. The EEQ IVR would be the first non-ARV MPT for women at high risk for both unintended pregnancy and HIV acquisition. The EEQ IVR has the potential to advance the MPT and drug delivery fields. In addition, the clinical study results may inform both the final size of the EEQ IVR and influence the size of future vaginal rings to be developed.