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Statement from TAG’s HIV Project on FDA’s Approval of Injectable Pre-Exposure Prophylaxis

CONTACT: Natalie Shure, natalie.shure@treatmentactiongroup.org

New York City, December 22, 2021 —Treatment Action Group (TAG) welcomes and celebrates the U.S. Food and Drug Administration’s (FDA) approval of Apretude brand cabotegravir, the first injectable medication for use as pre-exposure prophylaxis (PrEP) to reduce the risk of HIV transmission. Clinical trial results from two HIV Prevention Trials Network studies (HPTN 083 and 084) have demonstrated that long-acting shots administered around every eight weeks, or six times per year, were more effective for preventing acquisition of HIV through sexual activity, and associated with fewer side effects compared to daily oral medication. Importantly, the HPTN 084 trial proved the efficacy of injectable cabotegravir PrEP in women, a population that was omitted from clinical trials of Descovy (tenofovir alafenamide/lamivudine), a previously licensed PrEP intervention.

The recent FDA approval of injectable cabotegravir makes this new PrEP formulation an important addition to our HIV prevention toolbox. In combination with barrier protections, other effective biomedical interventions, and structural interventions to address social determinants of health – including resolving persistent disparities in access to PrEP that have hampered uptake by communities at highest risk of acquiring HIV, such as young Black and Latinx sexual minority men, Black women, and transgender people – injectable cabotegravir will bring us closer to the goal of ending the HIV epidemic in the U.S.

As TAG’s work has highlighted, we believe injectable cabotegravir’s potential  can be fully realized only when proactive steps are taken to guarantee universal access to this HIV prevention intervention. The work that led to the development and approval of injectable cabotegravir are certainly to be lauded. Yet, in order for this new PrEP option to maximally contribute toward ending the U.S. HIV epidemic, we must immediately and fully scale-up additional intervention studies, demonstration projects, and sociobehavioral science studies that address unique barriers to access for all major vulnerable populations – including transgender and gender-nonconforming people; Black, indigenous, Latinx and other communities of color; cisgender women; people who use drugs; and people living in the Southern U.S. and rural communities, which are generally underserved by HIV prevention services relative to urban areas.

Proactive steps to ensure universal access to cabotegravir and future long-acting technologies include: meaningful engagement and outreach to groups disproportionately affected by HIV; culturally competent messaging and education efforts; elimination of financial and other social-structural barriers such as systemic racism and provider discrimination in order to ensure access and uptake irrespective of identity, socioeconomic status, health insurance status, or geographic region; as well as equitable and evidence-based healthcare delivery in socially and economically marginalized communities. Critically, all forms of PrEP must be administered free of charge (i.e., with respect to both drug copays and associated clinical and laboratory services) for anyone who needs it, without cost-sharing; and pricing both domestically and globally must ensure unencumbered access among heavily impacted populations.

We call on all stakeholders, particularly federal, state and local health policymakers and health departments, to continue supporting the efforts of HIV advocates and community-based organizations, and commit to making universal access a reality, so that as many people as possible can benefit from injectable cabotegravir and all future innovations in biomedical HIV prevention.

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