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«ORAL PRE-EXPOSURE PROPHYLAXIS PUTTING A NEW CHOICE IN CONTEXT ORAL PRE-EXPOSURE PROPHYLAXIS PUTTING A NEW CHOICE IN CONTEXT CONTENTS BACKGROUND 2 ...»

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UNAIDS 2015 | REFERENCE

ORAL PRE-EXPOSURE

PROPHYLAXIS

PUTTING A NEW CHOICE IN CONTEXT

ORAL PRE-EXPOSURE

PROPHYLAXIS

PUTTING A NEW CHOICE IN CONTEXT

CONTENTS

BACKGROUND 2

ESSENTIAL PRINCIPLES FOR ORAL PrEP 3

PrEP is effective 3 PrEP must fit within the broader HIV response 3 PrEP is a prevention choice 3 PrEP is not for everyone: it is for people at substantial risk of HIV 3 PrEP: THE BASICS 4

PrEP AND TREATMENT WITHIN

A COMPREHENSIVE HIV PROGRAMME 5

THE NEED 6 DEMAND 7

COMBINATION PREVENTION 7

BROADER CONSIDERATION 7

Will PrEP reduce other safer sex behaviours? 7 Use of PrEP by women 7

PrEP AS PART OF A NATIONAL RESPONSE 8

WHERE AND BY WHOM COULD PrEP BE DELIVERED?

ELEMENTS OF A SUCCESSFUL PrEP PROGRAMME 8

National engagement with PrEP and current recommendations as of July 2015 9

COST CONSIDERATIONS 10

What next? Concrete steps to PrEP implementation 11

THE FUTURE BEYOND DAILY ORAL PrEP BASED ON TDF 12

PrEP FAST FACTS 13 THE ROLE OF UNAIDS 14 THE ROLE OF WHO 14 ABOUT AVAC 14

UNAIDS

BACKGROUND

The World Health Organization (WHO) anticipates releasing updated guidance on oral pre-exposure prophylaxis (PrEP), containing tenofovir (TDF), as an additional HIV prevention choice. The new guidance is likely to be significantly broader than previously and creates real opportunities to move forward with implementing PrEP as part of comprehensive HIV programmes.

This publication, produced collaboratively between UNAIDS, WHO and AVAC, is intended to complement WHO recommendations and support the optimal use of oral PrEP to protect individuals and contribute to ending the AIDS epidemic.

2 Oral pre-exposure prophylaxis–putting a new choice in context

ESSENTIAL PRINCIPLES FOR ORAL PrEP

PrEP is effective Pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission, and no significant difference has been found by sex, age or mode of sexual transmission.

Oral PrEP has been evaluated in gay men and other men who have sex with men, transgender women, heterosexual men and women and people who inject drugs.

In each of these contexts, the data are clear: PrEP works if taken correctly and consistently.

PrEP must fit within the broader HIV response Ending the HIV epidemic requires synergy around the three zeros–zero new HIV infections, zero discrimination and zero AIDS-related deaths. Implementing PrEP should enhance HIV programmes, including testing and scaling up treatment, and its delivery must always form part of a combination prevention approach. PrEP complements other evidence-informed prevention approaches, including condom and empowerment programmes for sex workers, harm reduction for people who inject drugs and efforts to change the legal and social context that increases the risk of acquiring HIV for many people.

PrEP is a prevention choice The decision to use PrEP rests with the individual. When presented with other HIV prevention options in a non-stigmatizing environment, individuals can choose the prevention strategy that is appropriate for them.

PrEP is not for everyone:

it is for people at substantial risk of acquiring HIV In deciding on who should be offered PrEP, needs and benefits (HIV prevention) should be balanced with harm (possible adverse events), costs and feasibility. People who are at substantial risk of acquiring HIV would achieve the greatest benefit from being able to access PrEP as an additional prevention choice.

–  –  –

PrEP: THE BASICS PrEP is the use of antiretroviral medication by people who are HIV negative to prevent them from acquiring HIV. PrEP trials have taken place in Africa, Asia, Europe, North America and South America.

The trials to date have used TDF-based regimens–either TDF combined with emtricitabine (FTC) or TDF alone. The United States Food and Drug Administration announced its approval of daily oral TDF + FTC for PrEP in July 2012, and the United States Centers for Disease Control and Prevention have produced PrEP implementation guidelines for adults at higher risk of HIV exposure.1 Key conclusions from PrEP efficacy and effectiveness studies and demonstration projects Oral PrEP containing TDF can be highly protective for both men and women.

„ Very low numbers of serious side effects have been seen in trials of TDF-based PrEP.

„ Adherence and ongoing follow-up with regular HIV testing are essential. People „ who had high levels of adherence had high levels of protection. Lower adherence was associated with low or no protection.

Where PrEP was proposed as a choice (in open-label extension and demonstration „ projects), people who would benefit most from PrEP used it most consistently.





PrEP poses a risk of drug resistance if a person has undetected HIV when „ initiating or restarting PrEP. PrEP is only for people who are HIV–negative.

The time elapsing before oral PrEP achieves high-level protection is five to seven „ days for anal sex and up to three weeks for vaginal sex.

PrEP AND TREATMENT WITHIN A COMPREHENSIVE

HIV PROGRAMME

The UNAIDS Fast-Track 2 approach, the 90–90–90 target3 and the prevention target of reducing the number of people acquiring HIV by 75% by 20204 all call for an expanded and accelerated scale-up of HIV treatment and combination prevention during the next five years. Using antiretroviral medicines for treatment and PrEP contributes synergistically to these targets and to the goal of zero discrimination.

1 Preexposure prophylaxis for the prevention of HIV infection in the United States – 2014 clinical practice guideline.

Atlanta: United States Centers for Disease Control and Prevention; 2014 (http://www.cdc.gov/hiv/pdf/guidelines/ PrEPguidelines2014.pdf, accessed 14 July 2015).

2 Fast-Track: ending the AIDS epidemic by 2030. Geneva: UNAIDS; 2014 (http://www.unaids.org/sites/default/files/ media_asset/JC2686_WAD2014report_en.pdf, accessed 14 July 2015).

3 By 2020, 90% of all people living with HIV will know their HIV status, 90% of all people who know their status will receive treatment and 90% of all people on treatment will have a suppressed viral load.

4 Understanding fast-track: accelerating action to end the AIDS epidemic by 2030. Geneva: UNAIDS; 2014 (http:// www.unaids.org/sites/default/files/media_asset/201506_JC2743_Understanding_FastTrack_en.pdf, accessed 14 July 2015).

–  –  –

Common issues with antiretroviral medicines in a time of expanded treatment and prevention Safety: modern antiretroviral medicines used for prevention and treatment are „ very safe. Laboratory monitoring can minimize the risks of side-effects and drug resistance.

Choice: use of prevention, treatment and all health services must be „ a personal choice, free of coercion. People need access to information to help them make informed choices.

Access: people have a right to evidence-informed HIV prevention, treatment and „ services. Ability to pay should not determine someone’s access to these services.

Social barriers: discrimination is a major barrier to testing, treatment and „ prevention and exacerbates vulnerability to HIV. Interventions to address these barriers are needed along with advocacy for legal and structural change.

Community role: community-based providers must play an increasing role in „ delivering prevention and treatment services, including PrEP. UNAIDS estimates that treatment provided in the community should increase from 5% today to 30% by 2020.5 Testing: taking an HIV test is the entry point for any use of antiretroviral „ medicines. After testing, people are offered treatment and positive prevention (if HIV–positive) or prevention options, including PrEP (if HIV–negative).

The availability of antiretroviral can enhance the uptake of testing.

Prices: drug prices are a major factor in access, and lowering the cost of medicines „ is central to wider treatment and PrEP delivery. Drug prices have fallen dramatically over time, and there is the potential for further decreases.

Delivery costs: new resources and efficiency can be found through integration „ with existing HIV budgets, technical support and service capacity along with appropriate task sharing.

Support: many people benefit from social support in adhering to HIV treatment, „ PrEP and other health programmes. Social protection, including longer periods of schooling, may reduce the risk of acquiring HIV among young people, especially girls.

5 Fast-Track: ending the AIDS epidemic by 2030. Geneva: UNAIDS; 2014 (http://www.unaids.org/sites/default/files/ media_asset/JC2686_WAD2014report_en.pdf, accessed 14 July 2015).

–  –  –

THE NEED The number of adults acquiring HIV is decreasing too slowly, and in some populations it is still rising. Additional prevention options are urgently required to respond to unmet prevention needs. PrEP is intended for people who are at substantial risk of HIV exposure and who do not always use condoms. This includes the people who lack the negotiating skills and power to insist on condom use as well as instances when condoms are exceptionally not available. PrEP can also be used specifically for safer conception.

Where there is no shared prevention decision-making, PrEP returns the control of the risk of acquiring HIV to the individual. PrEP is under personal control, it is invisible at the time of sex and the decision to take it is separate from the sex act.

As national programmes and funders focus on scaling up treatment to meet the 90–90–90 target, preventing people from becoming newly infected and reducing future treatment costs are also important. Testing and offering treatment to all individuals living with HIV will reduce the number of people acquiring HIV in the long term, but models and experience show that additional strategies are needed to contribute to ending the epidemic. UNAIDS modelling predicts that accelerating the scale-up of HIV prevention and treatment together will lead to significant economic benefits in low- and middle-income countries.6 HIV testing as the entry point for prevention and treatment HIV testing is being strengthened in accordance with the 90–90–90 target.

„ Appropriate linkage depending on test results will ensure that that the investment „ in scaling up testing has the maximum public health benefit.

People who test HIV–positive should be offered treatment.

„ Testing HIV–negative provides the opportunity to discuss individual high- risk „ HIV behaviour and prevention options of which PrEP could be a part.

Several research projects are investigating testing in populations with a high „ HIV incidence, linked to the choice of treatment or PrEP as appropriate. For serodiscordant couples, this includes the option of using PrEP as a bridge until viral suppression is achieved through the antiretroviral therapy of the partner living with HIV or for safer conception.

6 Fast-Track: ending the AIDS epidemic by 2030. Geneva: UNAIDS; 2014 (http://www.unaids.org/sites/default/files/ media_asset/JC2686_WAD2014report_en.pdf, accessed 14 July 2015).

–  –  –

DEMAND Information about PrEP is spreading at different rates in different parts of the world. Three years have passed since the United States Food and Drug Administration approved PrEP, and PrEP is just starting to change HIV prevention for gay men and other men who have sex with men in the United States. Other parts of the world have much less information about PrEP although growing activism on PrEP is contributing to raising awareness. Increasing the awareness of and demand for PrEP for those at higher risk of acquiring HIV should be part of a broader effort to scale up HIV prevention and treatment for all populations.

COMBINATION PREVENTION

The precise components of effective combination prevention vary depending on population needs but can include male and female condoms with condom-compatible lubricant, comprehensive harmreduction programmes, voluntary medical male circumcision, management of sexually transmitted infections, rights-based, peer-led behaviour counselling and viral suppression through treatment for people living with HIV. Since PrEP does not prevent other sexually transmitted infections and is not a contraceptive, its provision can be integrated with other sexual and reproductive health services.

BROADER CONSIDERATIONS

Will PrEP reduce other safer-sex behaviours?

No evidence has indicated this. Instead, evidence from trials suggests that PrEP can enable people to consider all their safer-sex strategies by addressing their fear and consequent denial of a higher risk of HIV.

Use of PrEP by women Daily oral PrEP is the only currently available option that HIV-negative people can use discretely and not at the time of sex—characteristics that may make it especially important for women, including young women, adolescent girls and also those who are concerned about acquiring HIV in the context of a stable partnership.

–  –  –

PrEP AS PART OF A NATIONAL RESPONSE

Identifying where to begin phased introduction The populations with the highest need for where PrEP can have the greatest impact can be given priority for initial implementation. Community ownership of HIV programmes is vital. All delivery of antiretroviral medicines should be discussed and designed cooperatively with potential users, their service providers, community leaders and programme planners, addressing barriers and strengthening enablers.



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