New licensing agreement set to double HIV vaginal ring supply in Africa

Good news for the thousands of girls and women in the sub-Saharan Africa region: A new licensing agreement is set to double the continental supply of a game-changing, long-acting HIV prevention tool. Made of flexible silicone, the dapivirine vaginal ring, or DPV-VR, which slowly releases the antiretroviral drug dapivirine in the vagina over one month, is the first long-acting HIV prevention method that is approved for use in women aged 18 and above. It has been described as an HIV prevention “breakthrough” and is reported to reduce the risk of HIV infection in women by over 50%. UNAIDS statistics indicate that in 2022, 53% of all people living with HIV were women and girls. In sub-Saharan Africa, girls and young women aged 24 and younger remain one of the most at-risk populations for HIV and AIDS, with infections over three times higher than those of similarly aged boys and young men. The production licensing agreement between the Population Council and Kiara Health, a South Africa-based pharmaceutical manufacturing and health solutions company, will offer women and girls in the region more options to protect themselves from HIV infection, said Anita Bhatia Garg, senior director for strategy and commercial relations at Population Council, the nongovernmental organization spearheading the international rollout of DVR. Under the agreement, Kiara Health will manufacture around 1 million of the PreP rings per year, doubling the current 500,000 rings that are currently supplied by the Swiss firm SPS Pharma for free distribution to women across Africa. SPS Pharma will continue manufacturing the ring for other global regions while Kiara Health supplies the African market. The agreement involves the transfer of technology, skills and know-how, and capacity building from the Population Council to Kiara Health. It also involves resource mobilization, grant funding, technical assistance for the technology transfer, and regulatory certification, including World Health Organization prequalification, marketing, and distribution operations. Garg said local production of the ring, which has regulatory approval for use in 11 countries in East and southern Africa, means that countries will have less logistical costs associated with the distribution of the ring, giving hope to the scores of women who are at high risk of HIV infection due to gender disparities. She said the licensing agreement with the South African pharmaceutical firm will also make the ring affordable and increase women’s access to the product, which will be purchased by country governments with support from the Global Fund to Fight AIDS, Tuberculosis and Malaria. The ring which lasts for 28 days currently costs between $12 to $15 but once the South African company starts production the cost is expected to drop to around $2.76 per ring as recommended by South Africa’s hospital expert review committee in 2022. “Women need different choices for HIV prevention at different stages of their lives, and the ring could be a critically important option. It complements existing HIV prevention tools and circumvents well-documented challenges that adolescent girls and young women face in taking pills on a daily basis,” Garg said. She said currently the ring is being offered to women through more than 30 implementation and pilot centers across six countries — Eswatini, Kenya, Lesotho, South Africa, Uganda, and Zimbabwe. While DVR is not approved for use in pregnant and breastfeeding women, results from a recent study in which 207 healthy pregnant women used the ring indicate that it may be safe to use. Similarly, another study found that the ring did not pose safety concerns when used by women who were breastfeeding. Jim Sailer, interim co-president and executive director at the Population Council’s Center for Biomedical Research, said in a press statement that women bear the brunt of the HIV/AIDS epidemic and deserve multiple options to protect themselves against the lifelong disease. “The virus is one of the biggest threats to the health and well-being of women. In sub-Saharan Africa, one adolescent girl or young woman becomes infected with HIV every three minutes. We cannot achieve the Sustainable Development Goal (SDG) of ending HIV by 2030 unless we curtail this epidemic in women,” Sailer said. He said the Reversing the Epidemic in Africa with Choices in HIV Prevention, or REACH, study recently published in Lancet HIV found that, after using both PrEP and the ring for six months each, 67% of the participants chose to use the ring while 31% preferred oral PrEP with 2% choosing to use neither. While studies document challenges to daily pill-taking, other newer formulations — including DVR and injectable cabotegravir — can directly address barriers to PrEP use among adolescent girls and young women, the REACH study concluded. Diantha Pillay, associate director for product access at the Population Council’s South African affiliate office, added that because of economic disparities and uneven power dynamics within sexual partnerships, women and girls are often unable to negotiate safer sex or even choose when or with whom they have sex. “These factors also drive gender-based violence, which further increases women’s risk of HIV infection. Therefore, there is a need for comprehensive prevention strategies that include options that women control,” she said. To ensure a long-term goal of commercial sustainability and local leadership, the Population Council is working toward granting an exclusive license for DVR in the current territories to Kiara Health which plans to set up local manufacturing capabilities over the next several years, to substantially lower the cost of the product. Meanwhile, the council is developing a longer-duration dapivirine ring that women would use for three months to significantly lower annual costs and offer women a more convenient option to protect themselves. Development of this longer-duration ring will be completed and submitted for regulatory approval by June after which Kiara Health will assume a leading role in ensuring its access.