Pre-exposure prophylaxis for HIV prevention

Tablets of Truvada, a tenofovir/emtricitabine combination used for HIV pre-exposure prophylaxis

Pre-exposure prophylaxis for HIV prevention, commonly known as PrEP, is the use of antiviral drugs as a strategy for the prevention of HIV/AIDS by people that do not yet have HIV/AIDS.[1] PrEP is one of a number of HIV prevention strategies for people who are HIV-negative but who have a higher risk of acquiring HIV, including sexually-active adults who are at increased risk of contracting HIV, people who engage in intravenous drug use (see drug injection), and serodiscordant sexually-active couples.[2]

The first form of PrEP for HIV prevention—emtricitabine and tenofovir disoproxil (FTC/TDF; Truvada)—was approved in 2012.[3] In October 2019, the U.S. Food and Drug Administration (FDA) approved the combination of emtricitabine and tenofovir alafenamide (FTC/TAF; Descovy) to be used as PrEP in addition to Truvada, which provides similar levels of protection.[4] Descovy, however, is currently approved only for cisgender males and transgender women as the efficacy has not been assessed in people at risk for HIV through receptive vaginal sex.[2]

In December 2021, the FDA approved cabotegravir (Apretude), which is an injectable form of PrEP manufactured by Viiv Healthcare. Regulators believe it will improve medication adherence because it has to be taken just once every two months, and it will also widen adoption as it eliminates the need to hide pills or pharmacy visits for discretion.[5]

In its 2021 guidelines, the World Health Organization (WHO) recommends multiple forms of PrEP for HIV prevention:[6]

  • Oral PrEP using TDF-containing compounds for anyone at substantial risk of HIV infection;
  • Event-driven PrEP for men who have sex with men; and
  • The dapivirine vaginal ring (DPV-VR) for women at substantial risk of HIV infection who do not have access to oral PrEP.[6]

This article provides information regarding PrEP's medical uses, contraindications and side effects, societal and cultural perspectives on its usage, and recent research studies.

Medical uses

Indications for use

United States

In the United States, federal guidelines updated in 2021 now recommend healthcare providers discuss and provide information on the use of pre-exposure prophylaxis (PrEP) for HIV prevention for all sexually active adults and adolescents.[2] The Centers for Disease Control and Prevention (CDC) recommends providers take a targeted sexual history of their patients to assess specific risk for HIV acquisition and suggest PrEP to the following patients:[2]

  • Sexually active adults and adolescents who have had anal or vaginal sex in the past 6 months and any of the following:
    • 1 or more partner(s) with unknown HIV status and inconsistent condom use;
    • An HIV-positive sexual partner (especially if they have an unknown or detectable viral load);
    • A bacterial sexually transmitted infection (STI) in the past 6 months.
  • Patients reporting injection drug use within the last 6 months and any of the following:
    • An HIV-positive injecting partner;
    • Shared injection equipment.

Additionally, these updated guidelines recommend providers prescribe PrEP to any patient that requests it, regardless of their stated risk factors.[2]

United Kingdom

In the United Kingdom the BHIVA/BASHH guidelines on the use of HIV pre-exposure prophylaxis (PrEP) 2018[7] recommend:

  • On-demand or daily oral Tenofovir – emtricitabine (TD-FTC) for HIV-negative MSM who are at elevated risk of HIV acquisition through unprotected anal sex in the previous six months and ongoing unprotected anal sex.
  • On-demand or daily oral TD-FTC for HIV-negative MSM having unprotected anal sex with partners who are HIV positive, unless the partner has been on ART for at least six months and their plasma viral load is <200 copies/mL.
  • Tenofovir (TDF) alone should not be offered to MSM.
  • Daily oral TD-FTC for HIV-negative heterosexual men and women having unprotected sex with partners who are HIV positive, unless the partner has been on ART for at least six months and their plasma viral load is <200 copies/mL.
  • Daily oral TD-FTC for heterosexual men and women on a case-by-case basis with current factors that may put them at increased risk of HIV acquisition.
  • TDF alone can be offered to heterosexual men and women where FTC is contraindicated.
  • PrEP is not recommended for people who inject drugs where needle exchange and opiate substitution programs are available and accessed by the individual.
  • PrEP with daily oral TD-FTC for HIV-negative trans women who are at risk of HIV acquisition through unprotected anal sex in the previous six months and ongoing unprotected sex.
  • Daily oral TD-FTC for HIV-negative trans women and trans men who have unprotected sex with partners who are HIV positive, unless the partner has been on ART for at least six months and their plasma viral load is <200 copies/mL.

Other Countries

Other government health agencies from around the world have devised their own national guidelines for how to use PrEP to prevent HIV infection in those at high risk, including Botswana, Canada, Kenya, Lesotho, South Africa, Uganda, the Zambia, and Zimbabwe.[8]

Eligibility, follow-up care, dosage

Per WHO guidelines, initiation of PrEP can be done if a person tests negative for HIV, has no signs of current HIV infection, has good kidney function (creatinine clearance >30 ml/min4) and no contraindications to the medication.[2] Once PrEP is initiated, individuals are asked to see their healthcare provider at least every three to six months. During those visits, providers should repeat testing for HIV, test for other sexually transmitted infections, monitor kidney function, and/or test for pregnancy.[9][2] Individuals must test negative for HIV prior to PrEP initiation because persons infected with HIV taking PrEP medication are at risk for becoming resistant to emtricitabine. Consequently, people with HIV infection and resistance to emtricitabine will have fewer options for selecting HIV treatment medications.[10]

A bottle of a generic version of emtricitabine/tenofovir, used for PrEP

Oral PrEP is typically taken daily following potential exposure. The CDC recommends follow-up visits at least every three months to provide HIV tests, medication adherence counseling, behavioral risk reduction support, side effect assessment, STI symptom assessment, and STI testing for sexually active individuals with symptoms of a current infection.[2] Pregnancy tests should also be done every three months for woman who may become pregnant.[2] At three months and every six months thereafter, renal function and presence of bacterial STI is assessed.[11][2] Effectiveness of PrEP is associated with adherence, meaning the more consistently a person takes the medication as prescribed the greater the chance at reducing their risk for HIV.[12]

Injectable PrEP (Cabotegravir) follows similar guidelines for eligibility and initiation criteria as oral PrEP medications.[2] However, instead of daily dosing, people who use injectable forms of PrEP will received one initial dose following a second dose after 1 month.[2] They can repeat dosing every 2 months after. Follow-up testing includes repeat HIV testing and STI screening. Those who decide to discontinue injectable PrEP may begin using oral PrEP within 2 months of their last injection.[2]

PrEP has been shown to be effective at reducing the risk of acquiring HIV in individuals at increased risk.[9] Studies evaluating PrEP efficacy to reduce risk of HIV infection found a linear relationship between adherence and effectiveness of medication. This means that the more closely people follow recommended dosing of PrEP, the more effective the medication is at preventing infection.[13] However, PrEP is not 100% effective at preventing HIV, even in people who take the medication as prescribed.[14] There have been several reported cases of people who acquired HIV despite taking PrEP.[15] People taking PrEP may use combination prevention strategies along with PrEP, such as condoms and other protective barriers methods.[9] If someone on PrEP acquires HIV, they may experience the signs and symptoms of HIV/AIDS.[16]

Event-driven PrEP

Although the daily, oral dosing schedule is still recommended for all individuals taking PrEP medication for HIV infection prevention, event-driven pre-exposure prophylaxis, or ED-PrEP, is an option for men who have sex with men. ED-PrEP is also referred to as "2+1+1" dosing, because the dosing regimen involves a person taking two pills two to twenty-four hours prior to sex, one pill twenty-four hours after taking the first two pills, and a last pill taken forty-eight hours after taking the first two pills.[17] This dosing regimen was first proven effective to reduce the relative risk of HIV infection by 86% in the IPERGAY randomized clinical trial performed in Canada and France in 2015.[18] This has only been evaluated with Truvada and not other drugs. According to the WHO, ED-PrEP should be considered for HIV infection prevention in men who have sex with men who have relatively infrequent sex, who are able to plan sex or delay sex for about two hours, and who find this dosing schedule convenient. ED-PrEP is not recommended for use in other populations, such as women and men who have sex with cisgender women, due to the lack of safety and efficacy data available.[18] ED-PrEP can be beneficial to help reduce the pill burden for people and decrease costs, as fewer pills are needed.[19]

PrEP During Pregnancy and Postpartum

The World Health Organization (WHO) recommendations support the use of PrEP in pregnant and breastfeeding people who are at substantial risk of HIV infection.[2][6][20] A growing body of evidence demonstrates the safety of TDF-containing oral PrEP during pregnancy and breastfeeding. This is an important time for prevention, as acquiring HIV during pregnancy increases the risk of transmission to the infant.[6] Global oral PrEP accessibility for women, including those who are either pregnant or breastfeeding, is limited. In addition, there is minimal research on the effects of injectable PrEP and pregnancy outcomes.[21] Efforts to increase accessibility to women who are at risk for HIV are necessary for reducing rates of global HIV infections.[22]

Contraindications

Truvada and Descovy

Truvada and Descovy are contraindicated for use as pre-exposure prophylaxis (PrEP) in individuals who have an unknown or positive HIV status.[2][23][24] HIV positive or negative status must be determined before someone begins the use of either of these medications as PrEP.[23][24] Additionally, any hypersensitivity or severe allergy to any ingredient, emtricitabine, tenofovir disoproxil, or tenofovir alafenamide is a contraindication for continued use of these medications.[23][24]

Side effects

Research shows that pre-exposure prophylaxis (PrEP) is generally safe and well tolerated for most individuals, although some side effects have been noted to occur.

Initial side effects may be experienced called "start-up syndrome." This includes nausea/abdominal pain, headaches, weight loss and/or diarrhea, which generally resolve within a few weeks of starting the PrEP medication.[2][9][25]

Research has shown that the use of Truvada has been associated with mild to moderate declines in kidney function, mostly associated with older people over 50, those with predisposing conditions such as diabetes, or glomerular filtration rate lower than 90.[26][23][27] These declines were usually of no concern, stabilized after several weeks of being on the drug, and reversed once the drug was discontinued.[28][29] In addition, a recent meta-analysis indicated no change in hepatic or renal function in patients using PrEP.[30] However, some of these side effects were serious enough for several people on PrEP to file lawsuits against the makers of Truvada as well as the makers of other similar drugs.[31][32][33]

While osteopenia or bone loss was reported in clinical studies, it was considered minimal and did not lead to osteoporosis.[34][35] When comparing bone fractures between active participants and control groups there was no significant difference in bone fractures.[35]

Fat redistribution and accumulation was more commonly seen in individuals receiving antiretroviral therapy, particularly older antiretrovirals, for the treatment of HIV.[36] No significant changes in fat redistribution or change in fat had been noted when used as a pre-exposure prophylaxis. Research and study outcome analysis suggests that emtricitabine/tenofovir does not have a significant effect on fat redistribution or accumulation when used as pre-exposure prophylaxis in HIV negative individuals.[37] As of early 2018, these studies have not assessed in detail subtle changes in fat distribution that may be possible with the drug when used as PrEP, and statistically significant – though transient – weight changes have been attributed to detectable drug concentrations in the body.[38]

Other potential serious side effects of Truvada include acute exacerbations of hepatitis B in individuals with HBV infection, lactic acidosis, and severe hepatomegaly with steatosis.[23]

Descovy research and data from public use has shown similar "start-up" effects; however, some data indicate that Descovy is better for one's kidneys and for those with a diagnosis of osteoporosis.[39] The DISCOVER trial that compared descovy versus truvada for PrEP showed that descovy produced safer kidney and bone outcomes.[40]

The injectable form of PrEP, Cabotegravir, shares similar side effects to oral PrEP such as nausea and headache. However, one of the most common side effect is pain at injection site.[21]

Boxed warnings

Both Truvada and Descovy carry a black box warning for the combination of emtricitabine/tenofovir, as this combination of drugs can result in the acute worsening of hepatitis B infection when discontinued. This combination of drugs is also known to increase HIV resistance to these medications when used as pre-exposure prophylaxis (PrEP) in individuals who have already (recently) been infected with HIV. Cabotegravir (Apretude) shares a similar black box warning to only use the medication if a person tests negative for HIV infection. It is recommended that individuals continue to periodically get tested to determine their HIV status to ensure proper continuing use of these medications for PrEP.[23][24]

Society and culture

Access and adoption

  Approved
  Under review
  Not approved
  No data

Approval for use

Truvada was previously only approved by the U.S. Food and Drug Administration (FDA) to treat HIV in those already infected. In 2012, the FDA approved the drug for use as pre-exposure prophylaxis (PrEP), based on growing evidence that the drug was safe and effective at preventing HIV in populations at increased risk of infection.[41] The FDA has approved two additional medications for PrEP since then, approving Descovy in 2019 and Cabotegravir (Apretude) in 2021.[4][5][2]

In 2012, the World Health Organization (WHO) issued guidelines for PrEP and made similar recommendations for its use among men and transgender women who have sex with men. The WHO noted that "international scientific consensus is emerging that antiretroviral drugs, including PrEP, significantly reduce the risk of sexual acquisition and transmission of HIV regardless of population or setting."[42]: 8, 10, 11  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."[43]: 4  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."[44]

As of 2018, numerous countries have approved the use of PrEP for HIV/AIDS prevention, including the United States, South Korea,[45] France, Norway,[46] Australia,[47] Israel,[48] Canada,[48] Kenya, South Africa, Peru, Thailand, the European Union[49][50], United Kingdom and Taiwan.[51]

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.[52]

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 March 21, 2018, the Federal Minister for Health announced that PrEP will be subsidized by the Australian Government through the Pharmaceutical Benefits Scheme (PBS) from April 1, 2018.[53] The Laurus Labs branded version is also available on PBS from October 2024.[54]

Lenacapavir

Lenacapavir could be available in the world’s poorest countries by late 2025 or early 2026, pending regulatory approvals from bodies like the FDA and the World Health Organization. The Global Fund to Fight AIDS, Tuberculosis and Malaria, stated that the goal is to begin distributing Gilead Sciences’ lenacapavir within that timeframe.[55] Already approved as a treatment for multi-drug resistant HIV—costing approximately $42,250 for the first year in the U.S.—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.[56] To expedite access for low- and middle-income countries, the Global Fund will collaborate with the U.S. 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.[57]

Availability and pricing in the United States

A bottle of 200 mg/25 mg emtricitabine 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 $2200/month (a 30-day supply) at wholesale price.[58][59] 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.[60][61] In the meantime, there are several assistance programs at the local, state, and national level for gaining access to PrEP at reduced costs.[58] Gilead has an "advancing access" co-pay coupon program that can be accessed by individuals and providers alike to help cover some of the monthly costs of these medications.[62]

In December 2019, the U.S. announced the Ready, Set, PrEP program to provide free PrEP to the uninsured through major drugstore chains.[63] The Ready, Set, PrEP program is led by the U.S. 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.[64]

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 U.S. that offer pre-exposure prophylaxis (PrEP) to prevent HIV infection. The database includes over 1,800 PrEP providers from all 50 U.S. states as well as U.S. territories.[65]

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).[66] 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.[67]

Politics and culture

Since the FDA approval of PrEP for the prevention of HIV, moves toward greater adoption of PrEP have been 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.[68] 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.[69] 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.[70] 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.[71] 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.[72] Other states and cities that have initiated "Getting to Zero" campaigns include Massachusetts, Connecticut, Illinois, San Diego, Silicon Valley/Santa Clara, and Miami-Dade.[73][74][75][76][77] In the UK the campaign Prepster has targeted young people of color[78]

Despite those efforts, PrEP remains controversial among some who worry that widespread PrEP adoption could cause public health issues by enabling risky sexual behaviors.[79][80][81] For instance, AIDS Healthcare Foundation founder and director 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.[82] New research, however, indicates that there is no change in STI rates following PrEP implementation.[83][84] Other critics point out that despite implementation of PrEP, significant disparities exist. For example, some point out that African Americans bear a disproportionate burden of HIV infections but may be less likely than whites to access PrEP.[85] 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.[86]

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.[87] PrEP does not prevent the transmission of sexually transmitted infections other than HIV, and is not 100% effective.[88]

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.[89] Other barriers include stigma and stereotyping from family, friends and providers.[89] A systematic review found that awareness of PrEP is low, but individuals were receptive to use when presented with information.[90] Common barriers to PrEP use include lack of communication between an individual and their doctor, stigmatization, concerns about safety, side effects, and cost and effectiveness.[91][90] 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.[92] However, primary care providers believe this is out of their scope of practice and PrEP use should be managed by HIV specialists.[92]

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".[93][94] Numerous other barriers were identified, including lack of quality LGBTQ care, cost, and adherence to medication use.[92]

Transgender women are disproportionally affected by HIV/AIDS,[95] and PrEP is often underused. Similar to the MSM community, stigma surrounding HIV posed as a barrier for PrEP use, along with low awareness, social support and tailored communication of PreP usage for transgender people.[95] Additional barriers transgender women face include concerns about side effects, hormone therapy, adherence, and interaction with healthcare workers.[96]

Challenges encountered by people engaging in injection drug use include limited access to healthcare providers, expense of medication, and follow-up for HIV testing.[92]

Cisgender women believe they are at low risk for HIV transmission even though they meet eligibility requirements for PrEP.[97] Low marketing for women, potential stigma from support system and lack of knowledge about PrEP posed as a barrier.[98][97]

For more information regarding barriers to healthcare access within the LGBTQIA+ community, see Healthcare and the LGBT community.

Research studies

Initial studies of PrEP strategies in non-human primates showed a reduced risk of infection among animals that receive ARVs prior to exposure to a simian form of HIV.[medical citation needed] A 2007 study at UT-Southwestern (Dallas) and the University of Minnesota showed PrEP to be effective in "humanized" laboratory mice.[99] In 2008, the iPrEx study demonstrated 42% reduction of HIV infection among men who have sex with men,[100] and subsequent analysis of the data has suggested that 99% protection is achievable if the drugs are taken every day.[101] Below is a table summarizing some of the major research studies that demonstrated PrEP with Truvada to be effective across different populations.[citation needed]

PrEP approaches with agents besides Truvada are being investigated. On December 20, 2021, the FDA approved Cabotegravir (Apretude), which was the first injectable drug for PrEP that is taken every two months.[5] There has been some evidence that other regimens, like ones based on the antiretroviral agent Maraviroc, could potentially prevent HIV infection.[102] Similarly, researchers are investigating whether drugs could be used in ways other than a daily pill to prevent HIV, including PrEP-releasing implants or rectally administered PrEP.[103]

Data on efficacy and safety of PrEP in adolescents are insufficient. Risks and benefits of PrEP use should be considered for adolescents.[11]

Study Type Type of PrEP Study Population Efficacy Percent of patients who took medication (adherence)
CAPRISA 004 Double-blind, randomized Pericoital tenofovir gel South African females 39% reduction of HIV infection[104] 72% by applicator count[105]
iPrEx Oral emtricitabine/tenofovir Men who have sex with men and transgender women 42% reduction of HIV infection.[100] 99% reduction estimated with daily adherence[101] 54% detectable in blood[106]
Partners PrEP Oral emtricitabine/tenofovir; oral tenofovir African heterosexual couples Reduction of infection by 73% with Truvada and 62% with tenofovir[107] 80% with Truvada and 83% with tenofovir[108] detectable in blood
TDF2 Oral emtricitabine/tenofovir Botswana heterosexual couples 63% reduction of infection[25] 84% by pill count[109]
FEM-PrEP Oral emtricitabine/tenofovir African heterosexual females No reduction (study halted due to low adherence) <30% with detectable levels in blood[110]
VOICE 003 Oral emtricitabine/tenofovir; oral tenofovir; vaginal tenofovir gel African heterosexual females No reduction in oral tenofovir or vaginal gel arms [oral emtricitabine/tenofovir arm ongoing][25] <30% with detectable levels in blood[111]
Bangkok Tenofovir Study Randomized, double-blind Oral tenofovir Thai male injection drug users 48.9% reduction of infection[112] 84% by directly observed therapy and study diaries[113]
IPERGAY Randomized, double-blind Oral emtricitabine/tenofovir French and Quebecois gay males 86% reduction of infection[18][114] (video summary Archived 11 July 2021 at the Wayback Machine) 86% with detectable levels in blood[18]
PROUD Randomized, open-label Oral tenofovir-emtricitabine High-risk men who have sex with men in England 86% reduction of HIV incidence[115]
HPTN 083 Randomized, double-blind Cabotegravir versus emtricitabine/tenofovir Transgender women and cisgender men who have sex with men in Argentina, Brazil, Peru, Thailand, the U.S., Vietnam, and South Africa. Highly efficacious compared to daily oral TDF/FTC.[116]
Discover study Randomized, double-blind oral TDF/FTC versus TAF/FTC High-risk men who have sex with men in Europe, North and South America TAF/FTC was non-inferior with more favorable bone and kidney outcomes [117]

Possibility of increased risk-taking

While PrEP appears to be extremely successful in reducing HIV infection, there is mixed evidence that there might be a change in use of condoms in anal sex,[118] raising risks of spreading sexually transmitted infections other than HIV. In a meta-analysis, researchers found no significant increase in risk for STIs following starting PrEP.[84] The same systematic review found there to be no change in amount of sexual partners or condom use while using PrEP.[84] In addition, PrEP be an opportunity for MSM to access sexual health care, testing, treatment and counseling services.[119]

Emerging treatments

Although HIV PrEP medications are only available in oral tablet and injectable formulations, other formulations are being developed and studied. The emerging treatments expand HIV prevention strategies for women. For example, a vaginal gel formulation of tenofovir and an intravaginal ring releasing dapivirine are under investigation for efficacy.[17] Out of three completed trials evaluating safety and efficacy of tenofovir vaginal gel, only the CAPRISA 004 trial showed the drug to be efficacious in decreasing the risk of HIV infection. However, the demonstrated effectiveness of tenofovir vaginal gel was deemed not significant enough to move forward with the product. In contrast, the ASPIRE study and The Ring Study evaluating the dapivirine-releasing intravaginal ring have demonstrated efficacy in reducing incidence of HIV infection. In addition to these two treatments, an injectable form of cabotegravir is being evaluated for efficacy in the HPTN 03 and HPTN 04 trials.[22]

At the 2024 International AIDS Conference, PrEP with long-acting injectable cabotegravir (CAB-LA; Apretude) appears safe during pregnancy among cisgender women, according to an analysis from the HPTN 084 open-label extension trial.[120] Researchers observed composite poor pregnancy outcomes in 33% of pregnancies with active CAB-LA use, 38% with prior CAB-LA use, and 27% with no CAB-LA use.[121]

See also

References

  1. ^ "Pre-Exposure Prophylaxis". HIV.gov. 3 December 2019. Retrieved 3 August 2020.
  2. ^ a b c d e f g h i j k l m n o p q Centers for Disease Control and Prevention: US Public Health Service (2021). "Preexposure prophylaxis for the prevention of HIV infection in the United States - 2021 Update: a clinical practice guideline" (PDF). Archived (PDF) from the original on 14 August 2023. Retrieved 23 August 2023.
  3. ^ "Oral PrEP TDF/FTC". PrEPWatch. 17 February 2023. Retrieved 23 August 2023.
  4. ^ a b "FDA approves the second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic". U.S. Food and Drug Administration (FDA) (Press release). 3 October 2019. Archived from the original on 10 October 2019. Retrieved 10 October 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ^ a b c "FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention". U.S. Food and Drug Administration. 20 December 2021. Retrieved 20 April 2022.
  6. ^ a b c d Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach. Geneva: World Health Organization. 2021.
  7. ^ BHIVA/BASHH guidelines on the use of HIV pre-exposure prophylaxis (PrEP) 2018
  8. ^ "National Policies and Guidelines for PrEP". PrEP Watch. Archived from the original on 8 December 2018. Retrieved 5 December 2017.
  9. ^ a b c d US Public Health Service. "Preexposure prophylaxis for the prevention of HIV infection in the United States - 2014" (PDF). Centers for Disease Control and Prevention (CDC). Archived from the original (PDF) on 11 April 2018. Retrieved 15 December 2017.
  10. ^ Riddell J, Amico KR, Mayer KH (March 2018). "HIV Preexposure Prophylaxis: A Review". JAMA. 319 (12): 1261–1268. doi:10.1001/jama.2018.1917. PMID 29584848. S2CID 205096939.
  11. ^ a b "Pre-exposure Prophylaxis for the Prevention of HIV Infection in the United States – 2017 Update Clinical Practice Guideline" (PDF). Centers for Disease Control and Prevention.
  12. ^ Chou R, Evans C, Hoverman A, Sun C, Dana T, Bougatsos C, et al. (June 2019). "Preexposure Prophylaxis for the Prevention of HIV Infection: Evidence Report and Systematic Review for the US Preventive Services Task Force". JAMA. 321 (22): 2214–2230. doi:10.1001/jama.2019.2591. PMID 31184746.
  13. ^ Mayer KH, Allan-Blitz LT (December 2019). "PrEP 1.0 and Beyond: Optimizing a Biobehavioral Intervention". Journal of Acquired Immune Deficiency Syndromes. 82 (2): S113–S117. doi:10.1097/QAI.0000000000002169. PMC 6830954. PMID 31658197.
  14. ^ "Pre-Exposure Prophylaxis (PrEP) | HIV Risk and Prevention | HIV/AIDS | CDC". www.cdc.gov. 4 June 2020. Retrieved 30 July 2020.
  15. ^ Ryan B (16 February 2017). "PrEP Fails in a Third Man, But This Time HIV Drug Resistance Is Not to Blame". Poz. Retrieved 15 December 2017.
  16. ^ Daar ES, Little S, Pitt J, Santangelo J, Ho P, Harawa N, et al. (January 2001). "Diagnosis of primary HIV-1 infection. Los Angeles County Primary HIV Infection Recruitment Network". Annals of Internal Medicine. 134 (1): 25–9. doi:10.7326/0003-4819-134-1-200101020-00010. PMID 11187417. S2CID 34714025.
  17. ^ a b Desai M, Field N, Grant R, McCormack S (December 2017). "Recent advances in pre-exposure prophylaxis for HIV". BMJ. 359: j5011. doi:10.1136/bmj.j5011. PMC 6020995. PMID 29229609.
  18. ^ a b c d Molina JM, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, et al. (December 2015). "On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection". The New England Journal of Medicine. 373 (23): 2237–46. doi:10.1056/NEJMoa1506273. PMID 26624850.
  19. ^ What's the 2+1+1? Event-driven oral pre-exposure prophylaxis to prevent HIV for men who have sex with men: Update to WHO's recommendation on oral PrEP. Geneva: World Health Organization; 2019 (WHO/CDS/HIV/19.8). Licence: CC BY-NC-SA 3.0 IGO.
  20. ^ "Preventing HIV During Pregnancy And Breastfeeding in the Context of PrEP". WHO Technical Brief: 16. 2017.
  21. ^ a b Guidelines on Long-Acting Injectable Cabotegravir for HIV Prevention. WHO Guidelines Approved by the Guidelines Review Committee. World Health Organization. 2022. PMID 36417549.
  22. ^ a b Hodges-Mameletzis I, Fonner VA, Dalal S, Mugo N, Msimanga-Radebe B, Baggaley R (August 2019). "Pre-Exposure Prophylaxis for HIV Prevention in Women: Current Status and Future Directions". Drugs. 79 (12): 1263–1276. doi:10.1007/s40265-019-01143-8. PMID 31309457. S2CID 196811170.
  23. ^ a b c d e f "Truvada- emtricitabine and tenofovir disoproxil fumarate tablet, film coated". DailyMed. Retrieved 9 December 2019.
  24. ^ a b c d "Descovy- emtricitabine and tenofovir alafenamide tablet". DailyMed. Retrieved 3 August 2020.
  25. ^ a b c Celum CL (December 2011). "HIV preexposure prophylaxis: new data and potential use". Topics in Antiviral Medicine. 19 (5): 181–5. PMC 6148898. PMID 22298887.
  26. ^ Marcus JL, Hurley LB, Hare CB, Nguyen DP, Phengrasamy T, Silverberg MJ, et al. (December 2016). "Preexposure Prophylaxis for HIV Prevention in a Large Integrated Health Care System: Adherence, Renal Safety, and Discontinuation". Journal of Acquired Immune Deficiency Syndromes. 73 (5): 540–546. doi:10.1097/QAI.0000000000001129. PMC 5424697. PMID 27851714.
  27. ^ Ascher SB, Scherzer R, Estrella MM, Shigenaga J, Spaulding KA, Glidden DV, et al. (April 2020). "HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine and changes in kidney function and tubular health". AIDS. 34 (5): 699–706. doi:10.1097/QAD.0000000000002456. PMC 7071971. PMID 31794523.
  28. ^ "New research at CROI 2016: How PrEP changes kidney function". San Francisco AIDS Foundation. 8 March 2016. Retrieved 3 August 2020.
  29. ^ Tetteh RA, Yankey BA, Nartey ET, Lartey M, Leufkens HG, Dodoo AN (April 2017). "Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns". Drug Safety. 40 (4): 273–283. doi:10.1007/s40264-017-0505-6. PMC 5362649. PMID 28130774.
  30. ^ Pereira M, de Castro CT, Magno L, Oliveira Td, Gomes FS, Neves FM, et al. (2023). "Adverse effects of daily oral pre-exposure prophylaxis in men who have sex with men and transgender women: a systematic review and meta-analysis". Cadernos de Saúde Pública. 39 (Suppl 1): e00089522. doi:10.1590/0102-311XEN089522. ISSN 0102-311X. PMC 10712916. PMID 38088646.
  31. ^ Kenslea G (11 April 2019). "41 HIV and PrEP Patients File California Personal Injury Lawsuit Over Gilead's TDF-Based Drugs". AIDS Healthcare Foundation (AHF). Retrieved 9 December 2019.
  32. ^ "AHF Calls on Gilead to Set Up $10 Billion Fund for Victims Harmed by its TDF-based Drugs". AIDS Healthcare Foundation (AHF). 16 July 2019. Retrieved 10 December 2019.
  33. ^ Petersen M (29 May 2016). "A question of timing: A lawsuit claims Gilead Sciences could have developed a less-harmful version of its HIV treatment sooner". Los Angeles Times. Retrieved 9 December 2019.
  34. ^ Grigsby IF, Pham L, Mansky LM, Gopalakrishnan R, Carlson AE, Mansky KC (March 2010). "Tenofovir treatment of primary osteoblasts alters gene expression profiles: implications for bone mineral density loss". Biochemical and Biophysical Research Communications. 394 (1): 48–53. doi:10.1016/j.bbrc.2010.02.080. PMC 2847063. PMID 20171173.
  35. ^ a b Kasonde M, Niska RW, Rose C, Henderson FL, Segolodi TM, Turner K, et al. (13 March 2014). "Bone mineral density changes among HIV-uninfected young adults in a randomised trial of pre-exposure prophylaxis with tenofovir-emtricitabine or placebo in Botswana". PLOS ONE. 9 (3): e90111. Bibcode:2014PLoSO...990111K. doi:10.1371/journal.pone.0090111. PMC 3953113. PMID 24625530.
  36. ^ "Changes to Your Face and Body (Lipodystrophy & Wasting)". Poz. Retrieved 16 February 2018.
  37. ^ "PrEP does not raise lipids or alter body fat, safety study finds". Retrieved 16 February 2018.
  38. ^ "Truvada as HIV PrEP not associated with net fat increase". www.healio.com. Retrieved 16 February 2018.
  39. ^ "Resource: Side-by-side comparison: Truvada and Descovy for PrEP". San Francisco AIDS Foundation. Retrieved 3 August 2020.
  40. ^ Mayer KH, Molina JM, Thompson MA, Anderson PL, Mounzer KC, De Wet JJ, et al. (25 July 2020). "Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial". The Lancet. 396 (10246): 239–254. doi:10.1016/S0140-6736(20)31065-5. PMC 9665936. PMID 32711800.
  41. ^ Gilead. "U.S. Food and Drug Administration Approves Gilead's Truvada for Reducing the Risk of Acquiring HIV". Gilead. Retrieved 15 December 2017.
  42. ^ "Guidance on oral pre-exposure prophylaxis (PrEP) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV: recommendations for use in the context of demonstration projects" (PDF). World Health Organization (WHO). July 2012.
  43. ^ "Policy brief: Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations, 2014" (PDF). World Health Organization (WHO). July 2014.
  44. ^ "WHO expands recommendation on oral pre-exposure prophylaxis of HIV infection (PrEP)" (PDF). World Health Organization (WHO). November 2015. Retrieved 18 December 2015.
  45. ^ "Korea has just approved PrEP but who can afford it at that price?". Gay Star News. 21 February 2018. Archived from the original on 5 January 2021. Retrieved 21 February 2018.
  46. ^ "Norway becomes first country to offer free PrEP - Star Observer". starobserver.com.au. 21 October 2016. Retrieved 12 January 2017.
  47. ^ "Pre-Exposure Prophylaxis (PrEP)". AFAO.org.au. Australian Federation of AIDS Organizations. Retrieved 15 December 2017.
  48. ^ a b "Canada and Israel OK Truvada as PrEP to Prevent HIV". Poz. 1 March 2016. Retrieved 12 January 2017.
  49. ^ Brooks M (22 July 2016). "Truvada Recommended as First Drug for HIV PrEP in Europe". Medscape. Retrieved 15 December 2017.
  50. ^ "First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU". European Medicines Agency (EMA) (Press release). 22 July 2016. Retrieved 12 January 2017.
  51. ^ "Pre-Exposure Prophylaxis (PrEP) for HIV Prevention" (PDF). Gilead Sciences Policy Position. Gilead Sciences. Retrieved 15 December 2017.
  52. ^ "HIV prevention drug Truvada to be publicly funded in New Zealand". TVNZ. Retrieved 7 February 2018.
  53. ^ "PrEP". Australian Federation of AIDS Organisations. Retrieved 31 July 2020.
  54. ^ "Securing supply of PrEP". Department of Health and Aged Care, ministerial press releases. Retrieved 1 October 2024.
  55. ^ Rigby J. "New HIV prevention drug could reach poorest countries by 2025, says health official". Reuters.
  56. ^ Nolen S (2 October 2024). "Gilead Agrees to Allow Generic Version of Groundbreaking H.I.V. Shot in Poor Countries". The New York Times. Archived from the original on 20 December 2024. Retrieved 22 December 2024.
  57. ^ "Global Fund, PEPFAR Announce Coordinated Effort to Reach 2 Million People with Lenacapavir for PrEP to Significantly Reduce Global HIV Infections". www.theglobalfund.org. Retrieved 22 December 2024.
  58. ^ a b "Truvada for HIV PrEP: How Much It Costs and How to Save - GoodRx". The GoodRx Prescription Savings Blog. 29 August 2018. Retrieved 4 August 2020.
  59. ^ Nelson G (22 March 2017). "Truvada". Positively Aware. Retrieved 4 August 2020.
  60. ^ "Generic HIV prevention drug coming in 2020, Gilead says". NBC News. 8 May 2019. Retrieved 4 August 2020.
  61. ^ Straube T (9 May 2019). "Generic PrEP to Arrive in September 2020, but Will Big Savings Follow?". POZ. Retrieved 4 August 2020.
  62. ^ "Gilead Advancing Access® Co-pay Coupon Program". www.gileadadvancingaccess.com. Retrieved 4 August 2020.
  63. ^ McNeil Jr DG (3 December 2019). "200,000 Uninsured Americans to Get Free H.I.V.-Prevention Drugs". The New York Times. Retrieved 10 December 2019.
  64. ^ "Pre-Exposure Prophylaxis". HIV.gov. 2019. Retrieved 3 August 2020.
  65. ^ "NPIN PrEP Provider Data and Locator Widget". Centers for Disease Control and Prevention. Archived from the original on 31 August 2022. Retrieved 31 July 2020.
  66. ^ "Bill Text - SB-159 HIV: preexposure and postexposure prophylaxis". leginfo.legislature.ca.gov. Retrieved 31 July 2020.
  67. ^ "California Makes PrEP and PEP Available Without Prescription". www.advocate.com. 7 October 2019. Retrieved 31 July 2020.
  68. ^ New York State Department of Public Health. "Ending the AIDS Epidemic in New York State". New York State Department of Public Health. Retrieved 15 December 2017.
  69. ^ "About HIV and San Francisco". Getting to Zero. San Francisco Department of Public Health. Retrieved 15 December 2017.
  70. ^ Allday E (15 September 2017). "Aggressive prevention pays off as new HIV infections in SF hit a record low". San Francisco Chronicle. Retrieved 15 December 2017.
  71. ^ Gay Men's Health Crisis (8 August 2016). "GMHC Launches PrEP Ad Campaign in New York City Bus Shelters". Gay Men's Health Crisis. Retrieved 15 December 2017.
  72. ^ Simmons-Duffin S. "PrEP Campaign Aims To Block HIV Infection And Save Lives In D.C." Washington Post. Retrieved 31 July 2020.
  73. ^ "Getting To Zero MA – Welcome to Zero HIV Stigma, Zero HIV Deaths, Zero HIV Infections". www.gettingtozeroma.org. Archived from the original on 5 October 2022. Retrieved 3 August 2020.
  74. ^ "Getting to Zero CT – Zero HIV Infections. Zero HIV Stigma. Zero HIV Deaths". Retrieved 3 August 2020.
  75. ^ "Home". gtzillinois.hiv. Retrieved 3 August 2020.
  76. ^ "Getting to Zero: Silicon Valley | Santa Clara County". Getting to Zero Silicon Valley. Retrieved 3 August 2020.
  77. ^ "Getting To Zero | Eliminate all new HIV infections in San Diego County within 10 years". Getting To Zero. Retrieved 3 August 2020.
  78. ^ "Prepster". Retrieved 9 May 2024.
  79. ^ Johnson SR (30 November 2018). "Clinicians warn HIV prevention drug use can lead to risky behavior". Modern Healthcare. Retrieved 10 October 2019.
  80. ^ Broder M (11 September 2017). "Does PrEP Lead to Riskier Behavior?". MedPageToday. Retrieved 10 October 2019.
  81. ^ Wise J (6 June 2018). "Pre-exposure prophylaxis may increase risky behaviour when introduced, study finds". BMJ: 361. doi:10.1136/bmj.k2514. S2CID 46965502.
  82. ^ Glazek C (26 April 2017). "The C.E.O. of H.I.V." The New York Times Magazine. Retrieved 15 December 2017.
  83. ^ Cairns G (22 February 2017). "STI rates in PrEP users very high, but evidence that PrEP increases them is inconclusive". AIDSMap.com. Retrieved 15 December 2017.
  84. ^ a b c O Murchu E, Marshall L, Teljeur C, Harrington P, Hayes C, Moran P, et al. (May 2022). "Oral pre-exposure prophylaxis (PrEP) to prevent HIV: a systematic review and meta-analysis of clinical effectiveness, safety, adherence and risk compensation in all populations". BMJ Open. 12 (5): e048478. doi:10.1136/bmjopen-2020-048478. ISSN 2044-6055. PMC 9096492. PMID 35545381.
  85. ^ Highleyman L (24 June 2016). "PrEP use is rising fast in US, but large racial disparities remain". AIDSMap.org. Retrieved 15 December 2017.
  86. ^ Gallagher J (3 August 2017). "Prep: HIV 'game-changer' to reach NHS in England from September". BBC News Online. Retrieved 15 December 2017.
  87. ^ Holt M, Lea T, Mao L, Kolstee J, Zablotska I, Duck T, et al. (August 2018). "Community-level changes in condom use and uptake of HIV pre-exposure prophylaxis by gay and bisexual men in Melbourne and Sydney, Australia: results of repeated behavioural surveillance in 2013-17". The Lancet. HIV. 5 (8): e448–e456. doi:10.1016/S2352-3018(18)30072-9. hdl:1874/377504. PMID 29885813. S2CID 47015652.
  88. ^ Anderson, P. L., Glidden, D. V., Liu, A., Buchbinder, S., Lama, J. R., ... Guanira, J. V. (2012). Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men. Science Translational Medicine, 4(151), 151ra125–151ra125. doi:10.1126/scitranslmed.3004006
  89. ^ a b Edeza A, Karina Santamaria E, Valente PK, Gomez A, Ogunbajo A, Biello K (3 June 2021). "Experienced barriers to adherence to pre-exposure prophylaxis for HIV prevention among MSM: a systematic review and meta-ethnography of qualitative studies". AIDS Care. 33 (6): 697–705. doi:10.1080/09540121.2020.1778628. ISSN 0954-0121. PMID 32530302. S2CID 219606855.
  90. ^ a b Koechlin FM, Fonner VA, Dalglish SL, O'Reilly KR, Baggaley R, Grant RM, et al. (May 2017). "Values and Preferences on the Use of Oral Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among Multiple Populations: A Systematic Review of the Literature". AIDS and Behavior. 21 (5): 1325–1335. doi:10.1007/s10461-016-1627-z. PMC 5378753. PMID 27900502.
  91. ^ "Increasing Access to HIV Prevention Medication | Healthforce Center". healthforce.ucsf.edu. Retrieved 3 August 2020.
  92. ^ a b c d Jin G, Shi H, Du J, Guo H, Yuan G, Yang H, et al. (1 December 2023). "Pre-Exposure Prophylaxis Care Continuum for HIV Risk Populations: An Umbrella Review of Systematic Reviews and Meta-Analyses". AIDS Patient Care and STDs. 37 (12): 583–615. doi:10.1089/apc.2023.0158. ISSN 1087-2914. PMID 38011347. S2CID 265463138.
  93. ^ Dubov A, Galbo P, Altice F, Fraenkel L (August 2018). "Stigma and Shame Experiences by MSM Who Take PrEP for HIV Prevention: A Qualitative Study". American Journal of Men's Health. 12 (6): 1843–1854. doi:10.1177/1557988318797437. PMC 6199453. PMID 30160195.
  94. ^ "PrEP slutshaming is still alive and well – and it's harming us all". 3 May 2024. Retrieved 15 May 2024.
  95. ^ a b Baral SD, Poteat T, Strömdahl S, Wirtz AL, Guadamuz TE, Beyrer C (March 2013). "Worldwide burden of HIV in transgender women: a systematic review and meta-analysis". The Lancet. Infectious Diseases. 13 (3): 214–22. doi:10.1016/S1473-3099(12)70315-8. PMID 23260128.
  96. ^ Pacífico de Carvalho N, Mendicino CC, Cândido RC, Alecrim DJ, Menezes de Pádua CA (October 2019). "HIV pre-exposure prophylaxis (PrEP) awareness and acceptability among trans women: a review". AIDS Care. 31 (10): 1234–1240. doi:10.1080/09540121.2019.1612014. PMID 31043069. S2CID 143425925.
  97. ^ a b Conley C, Johnson R, Bond K, Brem S, Salas J, Randolph S (January 2022). "US Black cisgender women and pre-exposure prophylaxis for human immunodeficiency virus prevention: A scoping review". Women's Health. 18: 174550572211030. doi:10.1177/17455057221103098. ISSN 1745-5057. PMC 9201306. PMID 35699104.
  98. ^ Bradley E, Forsberg K, Betts JE, DeLuca JB, Kamitani E, Porter SE, et al. (1 September 2019). "Factors Affecting Pre-Exposure Prophylaxis Implementation for Women in the United States: A Systematic Review". Journal of Women's Health. 28 (9): 1272–1285. doi:10.1089/jwh.2018.7353. ISSN 1540-9996. PMID 31180253. S2CID 182949977.
  99. ^ Denton PW, Estes JD, Sun Z, Othieno FA, Wei BL, Wege AK, et al. (January 2008). "Antiretroviral pre-exposure prophylaxis prevents vaginal transmission of HIV-1 in humanized BLT mice". PLOS Medicine. 5 (1): e16. doi:10.1371/journal.pmed.0050016. PMC 2194746. PMID 18198941.
  100. ^ a b Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. (December 2010). "Preexposure chemoprophylaxis for HIV prevention in men who have sex with men". The New England Journal of Medicine. 363 (27): 2587–99. doi:10.1056/NEJMoa1011205. PMC 3079639. PMID 21091279.
  101. ^ a b "PrEP: PK Modeling of Daily TDF/FTC (Truvada) Provides Close to 100% Protection Against HIV Infection". TheBodyPRO.com. Retrieved 28 February 2015.
  102. ^ Heitz D (23 February 2016). "The Possibility of PrEP that's Not Truvada". HIVEqual. Archived from the original on 15 December 2017. Retrieved 15 December 2017.
  103. ^ Heitz D (19 October 2015). "PrEP You Don't Swallow: The Future of Anal HIV Prevention". HIVEqual.com. Archived from the original on 1 April 2019. Retrieved 15 December 2017.
  104. ^ Andrei G, Lisco A, Vanpouille C, Introini A, Balestra E, van den Oord J, et al. (October 2011). "Topical tenofovir, a microbicide effective against HIV, inhibits herpes simplex virus-2 replication". Cell Host & Microbe. 10 (4): 379–89. doi:10.1016/j.chom.2011.08.015. PMC 3201796. PMID 22018238.
  105. ^ Mansoor LE, Abdool Karim Q, Yende-Zuma N, MacQueen KM, Baxter C, Madlala BT, et al. (May 2014). "Adherence in the CAPRISA 004 tenofovir gel microbicide trial". AIDS and Behavior. 18 (5): 811–9. doi:10.1007/s10461-014-0751-x. PMC 4017080. PMID 24643315.
  106. ^ "Adherence Indicators and PrEP Drug Levels in the iPrEx Study" (PDF). Archived from the original (PDF) on 4 March 2016. Retrieved 23 December 2015.
  107. ^ Celum C, Baeten JM (February 2012). "Tenofovir-based pre-exposure prophylaxis for HIV prevention: evolving evidence". Current Opinion in Infectious Diseases. 25 (1): 51–7. doi:10.1097/QCO.0b013e32834ef5ef. PMC 3266126. PMID 22156901.
  108. ^ Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. (August 2012). "Antiretroviral prophylaxis for HIV prevention in heterosexual men and women". The New England Journal of Medicine. 367 (5): 399–410. doi:10.1056/NEJMoa1108524. PMC 3770474. PMID 22784037.
  109. ^ Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. (August 2012). "Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana". The New England Journal of Medicine. 367 (5): 423–34. doi:10.1056/NEJMoa1110711. PMID 22784038.
  110. ^ "Top Stories: Poor Adherence Crippled PrEP Efficacy in Women's Study - by Tim Horn". aidsmeds.com. Archived from the original on 24 December 2015. Retrieved 23 December 2015.
  111. ^ "Top Stories: Failed VOICE PrEP Trial Failed to Preempt Lies About Adherence". aidsmeds.com. Archived from the original on 24 December 2015. Retrieved 23 December 2015.
  112. ^ Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, et al. (June 2013). "Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial". Lancet. 381 (9883): 2083–90. doi:10.1016/S0140-6736(13)61127-7. PMID 23769234. S2CID 5831642.
  113. ^ "Bangkok Tenofovir Study: PrEP for HIV prevention among people who inject drugs" (PDF). Centers for Disease Control and Prevention (CDC). Retrieved 23 December 2015.
  114. ^ Gilles Pialoux. "Ipergay: La Prep "à la demande", ça marche fort (quand on la prend)".
  115. ^ Dolling DI, Desai M, McOwan A, Gilson R, Clarke A, Fisher M, et al. (March 2016). "An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis". Trials. 17: 163. doi:10.1186/s13063-016-1286-4. PMC 4806447. PMID 27013513.
  116. ^ "HPTN 083 FAQ" (PDF). HPTN. 17 May 2020.
  117. ^ "DISCOVER Trial Factsheet". AVAC. 6 December 2016. Archived from the original on 17 May 2022. Retrieved 13 February 2019.
  118. ^ Holt M, Lea T, Mao L, Kolstee J, Zablotska I, Duck T, et al. (August 2018). "Community-level changes in condom use and uptake of HIV pre-exposure prophylaxis by gay and bisexual men in Melbourne and Sydney, Australia: results of repeated behavioural surveillance in 2013-17". The Lancet. HIV. 5 (8): e448–e456. doi:10.1016/s2352-3018(18)30072-9. hdl:1874/377504. PMID 29885813. S2CID 47015652.
  119. ^ Freeborn K, Portillo CJ (September 2018). "Does pre-exposure prophylaxis for HIV prevention in men who have sex with men change risk behaviour? A systematic review". Journal of Clinical Nursing. 27 (17–18): 3254–3265. doi:10.1111/jocn.13990. PMC 5797507. PMID 28771856.
  120. ^ "Long-acting injectable cabotegravir for HIV prevention is safe in pregnancy". National Institutes of Health (NIH). 23 July 2024. Retrieved 30 July 2024.
  121. ^ "Long-Acting Injectable Form of Cabotegravir Safe for HIV Prevention in Pregnant Cisgender Women". Pharmacy Times. 29 July 2024. Retrieved 30 July 2024.