South Africa approves PrEP

A quick post to note some excellent news from South Africa…

The Medicines Control Council announced that it has approved the use of once daily oral tenofovir and emtricitabine as pre-exposure prophylaxis (PrEP) for HIV. This makes South Africa the third country in the world to approve PrEP after the US and France.

Though many of the news stories are referring to the brand name Truvada, the approval is not for a specific branded pill but for the combination of the drugs in Truvada, which are available in generic form at greatly reduced cost in South Africa.

Exciting as this news it, it is only the first step towards making PrEP widely available in that country. Enormous hurdles remain:

Yet with this vital new development in the fight against Aids it is now more crucial than ever that remaining barriers to accessing PrEP are removed. Fundamentally this means educating South Africans that PrEP exists and may help them personally and making sure that PrEP can be feasibly delivered in public healthcare settings.

Around the world we know that knowledge about PrEP is still limited. We must make sure in South Africa that all people at risk of HIV are told accurately what PrEP can do, how it should be taken and where it can be accessed.

Equally, we must make sure that nurses have the necessary skills and tools to be able to roll out PrEP in public healthcare settings across South Africa. South Africa’s Anova Health Institute, in collaboration with the Desmond Tutu HIV Foundation, is currently implementing the largest state sector housed demonstration project for the use of PrEP. This project, taking place in Cape Town and Johannesburg, will gain the vital experience necessary to enable the department of health to take PrEP to scale.

PrEP is coming, but who will get it?

One of the big concerns for European governments considering whether and how to make Truvada available as pre-exposure prophylaxis for HIV (PrEP) is the cost. The medication itself is expensive, and it also requires on-going support from medical providers. In many European countries these costs will be borne largely or entirely by state-funded health systems.

Studies have consistently found that to be cost-effective PrEP, needs to be used by those at the highest risk of acquiring HIV. How high? The World Health Organization suggests that giving PrEP to people in groups with an incidence of 3% per year would be cost effective, while estimates in the UK suggest a minimum incidence of 5%.

Although gay and bisexual men generally are at elevated risk of infection, not every gay or bisexual man is at equally significant risk of acquiring HIV. In the US, the Centers for Disease Control and Prevention recently estimated that about 1 in 4 sexually active HIV-negative gay and bisexual men would benefit from PrEP.

One of the most important results of the PROUD trial in the UK was that the men in the study who were not using PrEP had an extremely high incidence of 9%. The French IPERGAY trial also found that men in the control group had a high rate of incidence (6.75%). This meant not only that Truvada as PrEP was (yet again) confirmed to be extremely effective at preventing HIV, but, crucially, that both studies had been extremely successful at recruiting men at very high risk of acquiring HIV.

But these studies were relatively small, and it’s not clear that simply applying the same criteria used for participation in the studies on a wider scale will be as effective at targeting the right people, or what criteria will be appropriate in other countries. While people at the highest risk of infection have been shown to be the most motivated to seek out and use PrEP, cost-conscious health systems want to have an idea of where to draw the line for eligibility so that those at low risk of infection do not use resources that could benefit others more.

So how do health authorities make sure they can reach those at higher risk, that the people who most need PrEP get it first?

How not to give a PEP talk

I sometimes wonder if post-exposure prophylaxis for HIV, or PEP, might have arrived too soon. The idea is sound: taking anti-retroviral medication (ARVs) immediately after exposure to HIV prevents the virus from establishing an infection. We know it works, but when PEP was first being rolled out the drugs that were available were pretty harsh compared to what’s available now. Unfortunately the reputation of being a debilitatingly rough experience still dogs PEP today.

With those early PEP regimens side effects were common and severe enough that a lot of people simply never finished the 28-day course of drugs. The regimens that are used now (in Ireland and the UK it’s Truvada and Isentress) are much milder. Most people experience no side effects, and even among those who do they are usually pretty mild. Failure to complete the course because of side effects has become extremely rare.

So when I run across things like this, from the page about PEP on Ireland’s newly revamped “Spun Out” youth information website, I get kind of discouraged:

PrEP in Europe: more calls for swift action

It’s been more than 3 years since the US Food and Drug Administration approved the use of Truvada as pre-exposure prophylaxis for HIV (PrEP). Since then mounting evidence has shown that not only is PrEP highly effective at preventing HIV infection but that often it is used most by those who can most benefit from it.

Unfortunately governments in Europe have been slow to act to approve Truvada for use as PrEP and to make it available to people at risk of HIV infection. Despite the clear evidence that PrEP works, European governments and health agencies have been cautious, expressing concern over cost-effectiveness and the complexities of how to provide a method of prevention that requires ongoing support from a variety of very different medical systems.

Recently though patience has been growing thin among advocates and the calls for European governments to take prompt action to make PrEP available have been growing louder and more widespread. Last week I posted about a new statement from the UK’s National AIDS Trust which urged the NHS to “provide PrEP without delay.” Days later the European AIDS Treatment Group (EATG) and the European AIDS Clinical Society released a strongly-worded statement declaring that “access to pre-exposure prophylaxis is essentially and urgently needed across Europe.”

PrEP and bone loss in young men

Here’s a piece from Wednesday by Liz Highleyman at hivandhepatitis.com discussing some new findings about PrEP and bone loss among young men. A presentation at the 15^th European AIDS Conference (taking place this week in Barcelona) revealed that “young men participating in a pre-exposure prophylaxis (PrEP) demonstration project experienced modest but significant bone loss after starting Truvada.”

Sounds kind of serious, but is this something to be hugely worried about? Is it bad news for advocates of PrEP? Well, no, not really.

UK National AIDS Trust: “NHS shouldn’t withhold PrEP any longer”

Following the release of the latest Public Health England report on HIV in the UK, the National AIDS Trust (NAT) called on the National Health Service to “provide PrEP without delay.”

According to the latest figures, there were 3,360 new HIV diagnoses among gay and bisexual men in the UK in 2014—the highest number ever recorded.

Emphasising that “current prevention work is making no dent on these numbers,” the NAT joins a growing chorus of organisations and individuals urging the NHS to act swiftly to make Truvada available for pre-exposure prophylaxis (PrEP) in the UK.