PrEP - 2018 - New potential population-wide benefits

Sep 27, 2026

2018 PrEP overview explaining pre-exposure prophylaxis as an antiretroviral-medication strategy used before exposure to reduce the risk of HIV infection for people at high risk. It summarizes evidence from studies since 2012 showing large reductions in new infections, notes key regulatory milestones including FDA approval in 2012 and CDC guidelines in 2014, and highlights WHO guidance enabling broader adoption. It also discusses an insurance underwriting perspective, including safety findings and discrimination concerns, and lists supporting bibliography items.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages2

Reading Time5 min

AccessFree to download

PrEP

New prevention approach and risk reduction

Evidence since 2012 and regulatory milestones

ARV-based prevention product development timeline

Regulatory status of Truvada for PrEP

Insurance perspective and considerations

Bibliography

PrEP 2018 New potential population-wide benefits Since the introduction of tritherapies, the survivalof patients infected with HIV has improved considerably. This has only been possible thanks to access to medical care and drugs. Today, a new prevention approach offers a treatment against human immunodeficiency virus (HIV) infection: the Pre-Exposure Prophylaxis (PrEP). Author Gabriela Buffet, Medical Officer Underwriting and Claims R&D Centre Pre-exposure Prophylaxis Against HIV Infection PrEP consists of the use of antiretroviral medication before exposure (daily or intermittently) to reduce the risk of becoming infected if the uninfected person is exposed to the virus. It is prescribed to men and women that are exposed toa high risk of contracting HIV. Since the first studies in 2012, PrEP has showed a significant reduction in the number of new infections between exposed people. In fact, PrEP is safe and highly effective, and it can reduce the risk of HIV infection from unprotected sex by over 90% . Several studies have shown that users who take the drug daily are at nearly zero risk of HIV infection. The US Food and Drug Administration (FDA) became the first national body to approve oral PrEP in 2012, which was subsequently followed by Centre for Disease Control (CDC) guidelines in 2014. In 2015, the World Health Organization (WHO) recognised the potential population-wide benefits of PrEP and released new guidelines recommending PrEP be offered to all people who are at substantial risk of HIV. Since then, PrEP policies have been implemented in most countries. In 2018, 24 countries approved PrEP guidelines for use. ILLUSTRATION OF THE LAST 20 YEARS OFARV-BASED PREVENTION PRODUCT DEVELOPMENT Events above the timeline are related to theARV-based prevention product pipeline and those below the line denote important milestones related to HIV prevention and care over the past 20 years. Dates and products represent timing of results unless otherwise noted. Data for this timeline was extracted from several sources. Product pipeline 2002 2007 2012 First PMTCT recommendations PEPFAR and ARV treatment in Africa HPTN 052 – Test and treat proof of concept Updated USCDC PrEP Guidelines Preliminary US CDC PrEP Guidelines (2011 & 2012) WHO PrEP Guidelines Southern African Clinician’s Society PrEP Guidelines 1997 2017 Milestones Post-exposure prophylaxis (1994) Carrageenan study BufferGel Cellulose sulfate gel MDP 301/pro 2000 gel CAPRISA 004 geliPrEX study (MSM) TDF2 and Partners PrEP (couples) FEMPrEP and VOICE Bangkok TDF (IDUs) FACTS 001 Dapivirine ring studies PrEP approved in 15 countires 2018 Paolo De Martin Editor SCOR 5, avenue Kleber 75795 Paris Cedex 16 France [www.scor.com](www.scor.com) REGULATORY STATUS OF TRUVADA FOR PrEP Updated October 2017; [https://www.hptn.org/resources/prevention](https://www.hptn.org/resources/prevention) Truvada approved for prevention1 Australia Belgium Canada England France Greece Israel Kenya Lesotho* Malawi Namibia Netherlands New Zealand Peru Scottland South Africa Slovenia Swaziland* Taiwan Tanzania Thailand United States Zambia Zimbabwe Regulatory application submitted for a prevention indication for Truvada2 Brazil Chile HongKong Nigeria South Korea Ukraine *Approved via import license from South Africa 1. India, SA and Kenya have generic PrEP approval. 2. The European Commission granted Gilead marketing authorization for Truvada as PrEP in Q3 2016. This should encourage countries with in the EU to make PrEP available within their national health systems, based on cost factors and individual country regulatory requirements INSURANCE PERSPECTIVE: Some critics of the PrEP policy say that people taking PrEP could increase risky sexual behaviour, however no such risk has been reported in studies. PrEP is an HIV prevention strategy where individuals who are not infected with HIV but may be at ri

FAQs

What is PrEP and how does it work?

PrEP uses antiretroviral medication before exposure, taken daily or intermittently, to reduce the risk of HIV infection when a person is exposed to the virus.

What evidence supports PrEP’s effectiveness and safety?

Since the first studies in 2012, PrEP has shown a significant reduction in new infections among exposed people. The document states PrEP is safe and highly effective, reducing the risk from unprotected sex by over 90%.

What regulatory and guideline milestones are mentioned for PrEP?

The document notes FDA approval of oral PrEP in 2012, CDC guidelines in 2014, and WHO guidelines in 2015 recommending PrEP for people at substantial risk. It also mentions that many countries implemented PrEP policies and that 24 countries approved PrEP guidelines for use in 2018.

Sep 27, 2026

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