Access and adoption In September 2025, partnerships led by the
Clinton Health Access Initiative,
Unitaid, and the
Gates Foundation secured agreements with
Indian manufacturers to provide lenacapavir for HIV prevention at US$40 per patient annually in 120 low- and middle-income countries.
Approval for use Truvada was previously only approved by the US
Food and Drug Administration (FDA) to treat HIV in those already infected. In 2012, the FDA approved the medication for use as pre-exposure prophylaxis (PrEP), based on growing evidence that the medication was safe and effective at preventing HIV in populations at increased risk of infection. The FDA has approved two additional medications for PrEP since then, approving Descovy in 2019 and cabotegravir (Apretude) in 2021. In 2014, on the basis of further evidence, the WHO updated the recommendation for men who have sex with men to state that PrEP "is recommended as an additional HIV prevention choice within a comprehensive HIV prevention package." In November 2015, the WHO expanded this further, on the basis of further evidence, and stated that it had "broadened the recommendation to include all population groups at substantial risk of HIV infection" and emphasized that PrEP should be "an additional prevention choice in a comprehensive package of services." , numerous countries have approved the use of PrEP for HIV/AIDS prevention, including the United States, South Korea, France, Norway, Australia, Israel, Kenya, South Africa, Peru, Thailand, the European Union, United Kingdom, and Taiwan. New Zealand was one of the first countries in the world to publicly fund PrEP for the prevention of
HIV in March 2018. Funded access to PrEP will require that people undergo regular testing for HIV and other sexually transmitted infections, and are monitored for risk of side effects. People taking funded PrEP will receive advice on ways to reduce the risk of HIV and sexually transmitted infections. In Australia, the country's
Therapeutic Goods Administration approved the use of Truvada as PrEP in May 2016, allowing Australian providers to legally prescribe the medication. On 21 March 2018, the Federal Minister for Health announced that PrEP will be subsidized by the Australian Government through the Pharmaceutical Benefits Scheme (PBS) from 1 April 2018. The Laurus Labs branded version is also available on PBS from October 2024.
Lenacapavir Lenacapavir could be available in the world's poorest countries by 2025 or 2026, pending regulatory approvals from bodies like the US
Food and Drug Administration (FDA) and the
World Health Organization (WHO).
The Global Fund to Fight AIDS, Tuberculosis and Malaria, stated that the goal is to begin distributing
Gilead Sciences' lenacapavir within that timeframe. Already approved as a treatment for multi-drug resistant HIV—costing approximately $42,250 for the first year in the US—lenacapavir has also shown strong efficacy in preventing HIV infection during recent clinical trials. Gilead is actively seeking regulatory approvals for its preventive use worldwide. To expedite access for low- and middle-income countries, the Global Fund will collaborate with the US
President's Emergency Plan for AIDS Relief (PEPFAR), with financial backing from the
Children's Investment Fund Foundation and the
Bill and Melinda Gates Foundation, aiming to make the expensive drug affordable in these regions from the outset.
Lenacapavir, as Yeztugo, is indicated for pre‑exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing more than who are at risk for HIV-1 acquisition. The
European Commission has approved Gilead's twice-yearly injectable lenacapavir—under the name Yeytuo—for HIV prevention across the
European Union, as well as in Norway, Iceland, and Liechtenstein. Gilead must now negotiate pricing and reimbursement terms with each country's health system, following a similar June approval in the U.S. where the drug is sold as Yeztugo and carries a list price exceeding $28,000 annually—an obstacle cited by some insurers. Additionally,
Gilead has submitted regulatory applications in several other countries—including
Australia, Brazil, Canada, South Africa, and Switzerland—and plans further filings in Latin America, while also expanding access in low- and middle-income nations through strategic agreements.
Availability and pricing in the United States and
tenofovir alafenamide, used for PrEP under the brand
Descovy, developed by
Gilead Sciences Within the United States, Truvada and Descovy are brand name products of
Gilead Sciences that cost around /month (a 30-day supply) at wholesale price. In other countries around the world, generic Truvada is available for a much lower price. Expected fall of 2020,
Teva Pharmaceuticals will begin producing a generic version of Truvada within the United States; however, it has been reported that the details surrounding the rights to the patent are unclear, which makes it difficult to predict if this will increase access to the medications. In the meantime, there are several assistance programs at the local, state, and national level for gaining access to PrEP at reduced costs. In December 2019, the US announced the
Ready, Set, PrEP program to provide free PrEP to the uninsured through major drugstore chains. The Ready, Set, PrEP program is led by the
US Department of Health and Human Services (HHS) and allows qualifying individuals to fill their prescription for PrEP medication free of cost at their choice of participating pharmacies or through the mail. NPIN PrEP Provider Data and Locator Widget was launched on the CDC website to provide a comprehensive, national directory of public and private providers in the US that offer pre-exposure prophylaxis (PrEP) to prevent HIV infection. The database includes over 1,800 PrEP providers from all 50 US states as well as US territories. Beginning in January 2020, after California Governor
Gavin Newsom signed Senate Bill 159 (SB159) in 2019, licensed pharmacists in California are authorized to initiate and dispense a 30 to 60 day supply of pre-exposure prophylaxis (PrEP) or the full course of
post-exposure prophylaxis (PEP) without a doctor's prescription, given certain clinical criteria of the individual are met. The bill acts as an extension of
Medi-Cal benefits (the
Medicaid program in the state of California). The law is recognized by pharmacist organizations, health providers, legislators, and the general public to be the removal of a barrier to direct and time-dependent access to these medications, especially for those in communities most affected by HIV/AIDS.
Politics and culture Since the FDA approval of PrEP for the prevention of HIV, moves toward greater adoption of PrEP have met some issues, especially around the overall public health effect of widespread adoption, the cost of PrEP and associated disparities in availability and access. Many public health organizations and governments have embraced PrEP as a part of their overall strategy for reducing HIV. For example, in 2014 New York state governor
Andrew Cuomo initiated a three-part plan to reduce HIV across New York that specifically emphasized access to PrEP. Similarly, the city of
San Francisco launched a "Getting to Zero" campaign. The campaign aims to dramatically reduce the number of new HIV infections in the city and relies on expanding access to PrEP as a key strategy for achieving that goal. Public health officials report that since 2013 the number of new HIV infections in San Francisco has decreased almost 50% and that such improvements are likely related to the city's campaign to reduce new infections. Additionally, numerous public health campaigns have been launched to educate the public about PrEP. For instance, in New York City in 2016
Gay Men's Health Crisis launched an ad campaign in bus shelters across the city reminding riders that adherence to PrEP is important to ensuring the regimen is maximally effective. In
Washington, D.C., a PrEP campaign was launched to increase the number of D.C. residents taking PrEP. Social media pushes, such as an ad campaign called "PrEP for Her", targeted African-American women, who, along with gay and bisexual African-American men, are at high risk of infection in the district. Other states and cities that have initiated "Getting to Zero" campaigns include Massachusetts, Connecticut, Illinois, San Diego, Silicon Valley/Santa Clara, and Miami-Dade. In the UK, the campaign
Prepster has targeted young people of color. Despite those efforts, PrEP remains controversial among some who worry that widespread PrEP adoption could cause public health issues by enabling risky sexual behaviors.
AIDS Healthcare Foundation founder Michael Weinstein has been vocal in his opposition to PrEP adoption, suggesting that PrEP causes people to make riskier decisions about sex than they would otherwise make, although the organization is the largest provider of PrEP in the U.S. New research, however, indicates that there is no change in STI rates following PrEP implementation. Still other critics of PrEP object to the high cost of the regimen. For example, the U.K.'s NHS initially refused to offer PrEP to individuals citing concerns about cost and suggested that local officials ought to bear the responsibility of paying for the drug. However, following significant advocacy efforts, the NHS started to offer PrEP to people in the UK in 2017.
Impact on the culture of men who have sex with men PrEP is used predominantly by men who have sex with men, often as an alternative to
condoms to allow otherwise unprotected "bareback" sex. For the first time since the outbreak of the AIDS crisis, PrEP makes somewhat HIV-protected sex without condoms possible, and since its availability,
sex without condoms has increased. PrEP does not prevent the transmission of sexually transmitted infections other than HIV and is not 100% effective.
Barriers to use Recent systematic reviews have investigated barriers to PrEP. On a structural level, findings indicate cost of PrEP, having multiple healthcare providers, and the frequency of follow-ups play a role. Other barriers include stigma and stereotyping from family, friends and providers. A possible explanation for low PrEP recommendations from physicians is the "Purview Paradox." This refers to HIV specialists believing primary care providers should be responsible for recommending and prescribing PrEP to patients. Within the MSM community, the greatest barrier to PrEP use has been the stigma surrounding HIV and gay men. Gay men on PrEP have experienced "
slut-shaming". Numerous other barriers were identified, including lack of quality LGBTQ care, cost, and adherence to medication use. and PrEP is often underused. Similar to the MSM community, stigma surrounding HIV poses a barrier for PrEP use, along with low awareness, requiring social support and tailored communication for transgender people regarding PrEP usage. Challenges encountered by people engaging in injection drug use include limited access to healthcare providers, expense of medication, and follow-up for HIV testing. Low marketing for women, potential stigma from support system and lack of knowledge about PrEP posed as a barrier. == Research studies ==