OVERVIEW OF PREP RESEARCH

Clinical trials on PrEP began in 2005. These trials have focused on the effectiveness of PrEP among people who inject drugs, HIV serodiscordant couples, heterosexual men and women, women at higher risk of HIV exposure, and men and transgender women who have sex with men (MSM-TG). Of these, two have completed as planned, one was stopped early for effectiveness, and two others were stopped or had arms discontinued for reasons of futility. The next section provides an overview of these trials. Section 3, Recommendations and the annexes (published on the Internet at http://www.who.int/hiv/pub/arv/prep_annex/en/) provide more detail about the clinical trials addressing the two populations that are the focus of this guidance.

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2.1. Clinical trials

The first daily oral PrEP trial to produce results was the 6-country iPrEx trial (4). This trial tested the combination of TDF and FTC in men who have sex with men and transgender women who have sex with men. It is the only Phase III trial of daily oral PrEP among MSM that has been completed, and no other trials are currently under way. iPrEx is included in the systematic review for the second PICO1 question (see Section 2.2, Systematic review of evidence). This trial found an overall reduction in HIV acquisition of 44%, with higher effectiveness in the most adherent users. In participants with measurable drug levels at clinic visits (indicating better adherence), effectiveness in preventing HIV acquisition reached 90%.

The second trial of daily oral TDF/FTC involved African women at higher risk of HIV in Kenya, South Africa and the United Republic of Tanzania. This trial was terminated early due to futility, that is, the inability to reach a conclusion: an equal number of infections were seen in the PrEP and placebo arms at interim analysis. The likely cause is poor adherence, with resultant low drug concentrations in study participants. Definitive conclusions are not yet available, however (8).

The third trial, the TDF2 study conducted in Botswana, studied daily use of oral TDF/FTC among heterosexual men and women (6). In this Phase IIb trial, PrEP reduced the risk of acquiring HIV infection by roughly 63% overall.

The fourth trial, Partners PrEP, evaluated daily oral TDF alone and daily oral TDF/FTC among HIV-1 serodiscordant couples in Kenya and Uganda. This study is included in the systematic review for the first PICO question. This trial found an overall effectiveness of 67% with TDF alone and 75% with TDF/FTC (5). With higher levels of adherence (as suggested by TDF levels in plasma), the effectiveness of oral TDF was 86% and of the TDF/FTC combination was 90% (9).

Two intervention arms of a fifth trial were stopped for futility. The VOICE trial, a trial being conducted among women in Uganda, South Africa and Zimbabwe, was assessing the effectiveness of daily oral TDF, daily oral TDF/FTC, and daily topical TDF gel, all compared with placebos. The daily oral TDF and the daily TDF gel arms were stopped when interim analysis found that a conclusion on the effectiveness of these two interventions could not be reached in this trial. The study will continue with daily oral TDF/FTC and is expected to produce results in early 2013.

Few concerns about safety, resistance or increased risky behaviour arose in any of the completed trials, which have involved more than 8000 participants.

In addition to these trials, one trial of tenofovir gel also has completed (10). This product, used as a vaginal gel inserted both before and after intercourse, reduced acquisition of HIV infection in women by 39% overall, again with higher effectiveness among the more adherent users.

What is PrEP?

PrEP — Pre Exposure Prophylaxis (PrEP) is a relatively new HIV prevention method where HIV-negative individuals use HIV medication to significantly reduce their risk of becoming infected if they are exposed to the virus.  

How effective is PrEP?

According to the PROUD study, in which 500 men who have sex with men (MSM) were enrolled, PrEP reduced the number of infections by up to 96%.  According to another research, the iPrEx study, in which 2499 MSM and transgender women were signed up, people who take PrEP pills daily acquire up to a 99% level of protection.
 

Check out links to these studies

WHO recommends PrEP?

With 2.7 million people becoming infected annually worldwide, both  the World Health Organization (WHO) and United States Centers for Disease Control and Prevention (CDC) recommend PrEP as  additional prevention choice for people at substantial risk of HIV infection (e.g., MSM).  as part of combination prevention approaches

Do we need new prevention tools ?

Condoms offer great protection against HIV, but there are many cases when many of us are forgetting or choosing not to use condoms.  Reasons like getting caught up in the moment, feeling that condoms block emotional intimacy, having difficulty keeping an erection, or too drunk to use condoms are often heard.

Also, external factors like homophobia, discrimination based on sexual orientation and gender expression, racism, poverty and homelessness, may encourage risky behaviour among marginalised MSM while also amplifying substantial health discrepancies across various socio-economic groups.

Goto Cohwa to know more.

A scientific estimation indicates that, without more effective intervention, MSM could make up half or more of all new HIV infections in Asia by 2020.

New prevention tools are urgently needed to change these trends. Now that PrEP has been shown to be effective in clinical trials, the next step is to ensure how you and other MSM around the world can have access to PrEP.

So all I need is just the prescription, right?

Yes and No. Yes, because you need to have a prescription from a health practitioner to take PrEP. No, because there’s more than just a prescription entailed in taking PrEP. PrEP is a programme. After your first prescription, you’ll be asked to come back to your doctor at least once in three months to do repeat HIV testing and other health checkups including STI screening and kidney function tests.

Does this mean I need to take PrEP for the rest of my life once I take it?

No, it does not! PrEP is not a lifetime strategy. Like birth control pills, you take the pills only when you are in the period where you need the protection the most. When you’re single and sexually active, taking PrEP daily – whether or not you think you will have sex that day – is essential. This is because it takes four to seven days of dosage adherence for you to reach maximum protection from HIV.

But, say you finally find the special one (yay for you!) who’s also HIV negative and you two decide to commit a monogamous relationship, your daily intake of PrEP may no longer be needed. But remember, it’s important to continue taking PrEP at least 28 days after a possible exposure.

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I’m afraid that taking PrEP will encourage me to engage in risky activities. 

Well, PrEP can’t control your personal choices BUT never assume that people who are taking PrEP are automatically taking more risky behaviours. Just because you’re given a life vest, it doesn’t mean you’re okay with your boat sinking, right? Does wearing a bike helmet encourage you to pedal on a highway? Does a bulletproof vest inspire police to get shot?

On the other hand, PrEP is an answer to the fact that behaviour change among adults is challenging. Smokers know that tobacco is dangerous, yet they have a hard time quitting. Exercise and a healthy diet are known to be important, yet obesity is still rising. We are facing the same problem with ending HIV.

The best way to encourage behaviour change is to provide people with options. After all, the best prevention option is the one you decide to use correctly and consistently.

Can I stop using Condoms if I'm on PrEP?

PrEP is not intended to replace condoms. Unlike condoms, PrEP does not protect against other sexually transmitted infections (STIs) like gonorrhoea, Chlamydia, or syphilis. For this reason, PrEP is generally recommended as a new prevention option, in addition to condoms.

Click here read more about what PrEP means for condom use.

What about the side effects? 

PrEP is a prophylactic approach and the medical world has been using prophylaxis as a method for a long time. Anti-malarial pills, for example, have been around for decades to help travellers to avoid malarial infection in tropical countries. These travellers are expected to start taking antimalarial drugs a few weeks before and during their journey. However, just like how anti-malaria pills are giving you protection against malaria vector mosquitos but not the dengue fever mosquitos and other tropical parasites, PrEP won’t protect you from other sexually transmitted infections such as gonorrhoea and syphilis.

For the first few weeks of starting PrEP, some people complain about nausea, vomiting, fatigue, and dizziness, with these minor symptoms eventually resolving themselves over time.

Read more about the side effects of Truvada here.Ther

What can I do to advocate for PrEP Access in Asia?

There are a number of things you can do to help advocate for increased PrEP access in Asia. Here is a list of 8 things that you can do right now! Advocate for PrEP!

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