Pre-exposure prophylaxis for HIV prevention - Wikipedia

11/26/24, 1:01 PM Pre-exposure prophylaxis for HIV prevention - Wikipedia
Pre-exposure prophylaxis for HIV

prevention
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
Tablets of Truvada, a
serodiscordant sexually-active couples.[2] tenofovir/emtricitabine combination
used for HIV pre-exposure
The first form of PrEP for HIV prevention—emtricitabine and prophylaxis
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]
https://en.wikipedia.org/wiki/Pre-exposure_prophylaxis_for_HIV_prevention 1/22
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]
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 A bottle of a generic version of
emtricitabine/tenofovir, used for
eligibility and initiation criteria as oral PrEP medications.[2]
PrEP
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] 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]
Availability and pricing in the United States
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.[55][56] 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.[57][58] In the meantime,
there are several assistance programs at the local, state, and
national level for gaining access to PrEP at reduced costs.[55]
Gilead has an "advancing access" co-pay coupon program that
A bottle of 200 mg/25 mg
can be accessed by individuals and providers alike to help cover emtricitabine and tenofovir
some of the monthly costs of these medications.[59] alafenamide used for PrEP under
the brand Descovy, developed by
In December 2019, the U.S. announced the Ready, Set, PrEP Gilead Sciences.
program to provide free PrEP to the uninsured through major
drugstore chains.[60] 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.[61]
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.[62]
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).[63]
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.[64]
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.[65] 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.[66] 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.[67] 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.[68] 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.[69] Other states and cities that have initiated "Getting to Zero" campaigns
include Massachusetts, Connecticut, Illinois, San Diego, Silicon Valley/Santa Clara, and Miami-
Dade.[70][71][72][73][74] In the UK the campaign Prepster has targeted young people of color[75]
Despite those efforts, PrEP remains controversial among some who worry that widespread PrEP
adoption could cause public health issues by enabling risky sexual behaviors.[76][77][78] 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.[79] New research, however, indicates that there is no
change in STI rates following PrEP implementation.[80][81] 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.[82] 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.[83]
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.[84] PrEP does not prevent the transmission of
sexually transmitted infections other than HIV, and is not 100% effective.[85]
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.[86] Other barriers include stigma and stereotyping from family, friends and providers.[86] A
systematic review found that awareness of PrEP is low, but individuals were receptive to use when
presented with information.[87] 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.[88][87] 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.[89] However, primary care
providers believe this is out of their scope of practice and PrEP use should be managed by HIV
specialists.[89]
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".[90][91] Numerous other
barriers were identified, including lack of quality LGBTQ care, cost, and adherence to medication
use.[89]
Transgender women are disproportionally affected by HIV/AIDS,[92] 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.[92] Additional barriers transgender women face include concerns about side effects,
hormone therapy, adherence, and interaction with healthcare workers.[93]
Challenges encountered by people engaging in injection drug use include limited access to
healthcare providers, expense of medication, and follow-up for HIV testing.[89]
Cisgender women believe they are at low risk for HIV transmission even though they meet
eligibility requirements for PrEP.[94] Low marketing for women, potential stigma from support
system and lack of knowledge about PrEP posed as a barrier.[95][94]
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. A 2007 study at UT-
Southwestern (Dallas) and the University of Minnesota showed PrEP to be effective in
"humanized" laboratory mice.[96] In 2008, the iPrEx study demonstrated 42% reduction of HIV
infection among men who have sex with men,[97] and subsequent analysis of the data has
suggested that 99% protection is achievable if the drugs are taken every day.[98] Below is a table
summarizing some of the major research studies that demonstrated PrEP with Truvada to be
effective across different populations.
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.[99] 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.[100]
Data on efficacy and safety of PrEP in adolescents are insufficient. Risks and benefits of PrEP use
should be considered for adolescents.[11]
Percent of
patients
Study
Study Type Type of PrEP Efficacy who took
Population
medication
(adherence)
72% by
CAPRISA Double-blind, South African 39% reduction of HIV
Pericoital tenofovir gel applicator
004 randomized females infection[101]
count[102]
Men who 42% reduction of HIV
have sex with 54%
Oral infection.[97] 99% detectable in
iPrEx men and
emtricitabine/tenofovir reduction estimated with
transgender blood[103]
women daily adherence[98]
80% with
Truvada and
Oral African Reduction of infection by
Partners 83% with
emtricitabine/tenofovir; heterosexual 73% with Truvada and
PrEP tenofovir[105]
oral tenofovir couples 62% with tenofovir[104]
detectable in
blood
Botswana 63% reduction of 84% by pill

Oral
TDF2 heterosexual
emtricitabine/tenofovir
couples infection[25] count[106]
<30% with
African detectable
FEM- Oral No reduction (study halted
heterosexual levels in
PrEP emtricitabine/tenofovir due to low adherence)
females
blood[107]
No reduction in oral
Oral <30% with
African tenofovir or vaginal gel
VOICE emtricitabine/tenofovir; detectable
heterosexual arms [oral
003 oral tenofovir; vaginal levels in
females emtricitabine/tenofovir
tenofovir gel blood[108]
arm ongoing][25]
84% by
directly
Bangkok Thai male
Randomized, 48.9% reduction of observed
Tenofovir Oral tenofovir injection drug
Study
double-blind
users infection[109] therapy and
study
diaries[110]
86% reduction of
infection[18][111] (video
summary (http://www.nej
m.org/action/showMediaP
layer?doi=10.1056%2FNE
JMoa1506273&aid=NEJM
oa1506273_attach_1&are 86% with
French and
Randomized, Oral a=) Archived (https://web. detectable
IPERGAY Quebecois
double-blind emtricitabine/tenofovir archive.org/web/20210711 levels in
gay males
195758/https://www.nejm. blood[18]
org/action/showMediaPlay
er?doi=10.1056%2FNEJ
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Wayback Machine)
High-risk men
Randomized, Oral tenofovir- who have sex 86% reduction of HIV
PROUD
open-label emtricitabine with men in incidence[112]
England
HPTN Randomized, Cabotegravir versus Transgender Highly efficacious

083 double-blind emtricitabine/tenofovir women and compared to daily oral
cisgender TDF/FTC.[113]
men who
have sex with
men in
Argentina,
Brazil, Peru,
Thailand, the
U.S.,
Vietnam, and
South Africa.
High-risk men
who have sex TAF/FTC was non-inferior
Discover Randomized, oral TDF/FTC versus with men in with more favorable bone
study double-blind TAF/FTC Europe, North
and South and kidney outcomes [114]
America
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,[115] 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.[81] The same systematic review found there to be
no change in amount of sexual partners or condom use while using PrEP.[81] In addition, PrEP be
an opportunity for MSM to access sexual health care, testing, treatment and counseling
services.[116]
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.[117] 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.[118]
See also
Chemoprevention
Post-exposure prophylaxis (PEP)
National AIDS Trust v NHS Service Commissioning Board
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External links
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Centers for Disease Control and Prevention (CDC)
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11/26/24, 1:01 PM Pre-exposure prophylaxis for HIV prevention - Wikipedia

Pre-exposure prophylaxis for HIV

Indications for use

Eligibility, follow-up care, dosage

Oral PrEP is typically taken daily following potential exposure.

PrEP During Pregnancy and Postpartum

Truvada and Descovy

Additionally, any hypersensitivity or severe allergy to any ingredient, emtricitabine, tenofovir

Society and culture

Access and adoption

Approval for use

Availability and pricing in the United States

Within the United States, Truvada and Descovy are brand

Politics and culture

Impact on the culture of men who have sex with men

Botswana 63% reduction of 84% by pill

HPTN Randomized, Cabotegravir versus Transgender Highly efficacious

Possibility of increased risk-taking

National AIDS Trust v NHS Service Commissioning Board

51. "Pre-Exposure Prophylaxis (PrEP) for HIV Prevention" (http://www.gilead.com/~/media/files/pdf

Retrieved from "https://en.wikipedia.org/w/index.php?title=Pre-

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