Pre-Exposure Prophylaxis or PrEP

Pre-exposure prophylaxis (PrEP) involves putting HIV negative people on antiretroviral drugs (ARV) with the aim of protecting them from HIV infection. This blog looks at some of the pros and cons of PrEP.

Friday, September 30, 2011

Health in Africa: Always a Crisis, Never a Priority

Tanzania and Kenya are both issuing warnings about 'fake' and unregistered drugs. Unfortunately, many people have been led to believe that 'fake', 'generic', 'counterfeit' and even drugs with 'Made in China' on them are all the same; useless. The chances of protecting people from substandard drugs, out of date drugs, those with the wrong ingredients, those with no active ingredients or those with the wrong quantities of ingredients, etc, is now seriously diminished.

The pharmaceutical industry, not short of a few billion dollars itself, wants regulatory authorities and others to protect the industry's profits, so they are in favor of such scare tactics. But they have brought about the situation where people will produce their own versions of drugs and create a thriving black market. Big Pharma has failed to produce drugs at a price that is affordable to those who need them most.

I suppose I have to spell it out that I don't think there's anything wrong with making a profit. But many drugs are developed using public money, in publicly funded institutions. The cost of researching drugs, which is very high, is not entirely borne by the industry. Only the profits are entirely borne by the industry. And the same industry often spends many times more on advertising, lobbying and marketing than they do on research.

There really is a problem with drug supply in East African countries; there are too few of them, many are of the wrong kind, some are fake or counterfeit. But some are generic, that being the best that people in developing countries, the majority of people in the world, can afford. And all drugs, even generic drugs, are overpriced. There is still no true competition, where prices are set according to what the market can bear rather than what the over-subsidized industry can grab.

Pharmaceutical outlets, even many health facilities in East Africa, can be badly run, semi-formal, informal or downright illegal, and are in bad need of regulation. But running around closing them down or curtailing their activities will do little good unless proper facilities are made available to people. The lion's share of health spending in East Africa goes into the pockets of Big Pharma, mostly for branded drugs and products developed with Western needs and economies in mind. There's no shortage of money.

Unsafe drugs are only one of the many risks that East African people face in pharmacies and health facilities. The priority is to improve conditions in these facilities and increase people's access to them, not to increase the amount of donor and public money that helps inflate pharmaceutical industry profits. Drugs are only a part of health care, but only when there are adequate health facilities with enough well trained and equipped staff. Stop using aid money to support pharmaceutical multinationals!

[For more about unsafe health care and cosmetic services, visit the Don't Get Stuck With HIV website]


Wednesday, September 21, 2011

Drug-Based HIV 'Prevention' Strategies Alone Will Fail

While about 25% of HIV postive people in the US and the UK are thought not to know their status, only about the same percentage of people in some African countries are aware of their status. Many years of testing campaigns are only changing that figure slowly. But the pace of development in pharmaceutical products and treatment practices available is way ahead of the testing campaigns. Marketing and media campaigns are similarly ahead of the game, ahead of the evidence, some might say.

PrEP has been undergoing various trials for quite a few years now, but it has not yet shown itself to be the most appropriate strategy in countries with high HIV prevalence rates. Even 'test and treat' ("testing all adolescents and adults annually for HIV infection and immediately treating those found to be infected") may sound good on paper; but it will struggle to prove itself as a strategy in less well off countries.

Test and treat would work best if it could catch new HIV infections at the earliest clinical stage, during which it is most likely to be transmitted to others. But if far less than half of the HIV positive people know their status, the chances of a substantial number of early infections being identified are small. It is more likely that most infections will continue to be identified when people have been infected for many years, even at the latest stage of infection (which is often far too late).

If the plan is to test sexually active people every year, this will involve a huge scaling up of current testing practices and a massive change in the testing behaviors of the entire population of quite a number of poor countries. One might even ask if testing sexually active people once a year is enough, given that 'early stage of HIV infection' means the first six months. (Testing at least every six months is estimated to be required by the author of the above article.) But this must be compared to the consideration that the majority of people in African countries have never tested; many of those who have tested only did so once.

Like PrEP, test and treat seems suspiciously passive, as if we are waiting till lots more people become infected and then treating them with the ostensible aim of preventing further infection. In conjunction, these strategies will be great for pharmaceutical company profits, there's no question about that. But as to whether they will cut infection rates substantially, there is plenty of room for doubt. Early initiation of antiretroviral therapy (ART) has also been pushed as a highly beneficial strategy, but the evidence is not yet convincing.

These three strategies (PrEP, test and treat and early ART initiation) are a little like prevention of mother to child transmission (PMTCT) in that they require at least one infection in order to 'protect' some unknown number of infections in the future. The percentage reduction in mother to child transmission gained through use of PMTCT is, of course, well established. But brilliant levels of PMTCT rollout, and it is by no means widespread in many of the highest prevalence countries, is puny when compared to low HIV prevalence among young women, pregnant women and mothers.

South Africa has the highest number of HIV positive people in the world, over five million. The majority of new infections are occurring in young women. To the best of my knowledge, no large scale effort has ever been made to asses the sexual and non-sexual HIV risks that these women face. The view that they are almost all infected through heterosexual behavior is still just an assumption, albeit one supported by almost every HIV academic currently writing. If there are HIV positive people infecting these women, find them. They also need treatment, more urgently than anyone else.

This is not a call to increase the levels of anti-African prejudice that UNAIDS and the HIV industry currently enjoys; it is a serious suggestion that sexual partners of young HIV positive women be identified. Many South African men, young and old, will be found to be HIV negative. The same would be true of men in other high prevalence African countries. Therefore, young women's non-sexual risks also need to be identified.

The above HIV drug-based strategies center around the belief that HIV is almost always transmitted through heterosexual sex and almost never through any non-sexual routes, such as unsafe medical or cosmetic services. If these assumptions turn out to be false, the above strategies will cease to appear so tempting.


Tuesday, September 13, 2011

PrEP: How Many Lightbulbs Does it Take to Change a Prejudice?

One of the biggest puzzles that the HIV industry hasn't answered is that it is mostly intravenous drug users and men who have sex with men who are infected with HIV in Western countries, for example, the US. But it is mostly heterosexuals, the majority of whom don't engage in particularly risky behavior, who are infected in African countries. This is a potentially huge problem for PrEP (pre-exposure prophylaxis).

There's a rather smug article on entitled "HIV Experts Create the Roadmap for Providing PrEP to Uninfected Individuals to Reduce the Risk of HIV Infection". But the remarks in the article, while possibly relevant to those in Western countries, seem to have little relevance to people in the highest prevalence countries. That's not unusual in articles about PrEP and HIV drugs in general, but it doesn't inspire confidence in these 'experts'.

Firstly, it is not possible to target those 'most at risk' if you don't know who they are. Most new infections in African countries are not people who could be considered to be taking a lot of risks, not sexual risks, anyhow. Take, for example, Uganda. Most new infections are among those in long term relationships, a good many of them are not promiscuous and a good many have partners who are HIV negative.

Secondly, if the risks people face are not sexual, PrEP may not be the most appropriate prevention strategy. It's obtuse to prescribe PrEP to someone who is at risk of being infected at a dental clinic, in a hospital or at a tattoo parlour. And there are far more effective and cheaper options.

If the industry doesn't accept that people face non sexual risks they will fail to protect those who are genuinely at risk. Even those whose main risks are sexual will also probably be missed out. Because of the stigma attaching to HIV where heterosexual sex is said to be the main problem (as is the case in Africa, but not elsewhere), people don't wish to be tested, to talk about their status or to even face the possibility of infection in others.

PrEP is unlikely to be the most appropriate pretection from HIV infection for intravenous drug users, either. It would be far cheaper and more effective to provide them with counselling and supplies of clean injecting equipment. But as with men having sex with men and commercial sex work, criminalization ensures that those at risk are unlikely to come forward and unlikely to get the treatment they need if they do.

If and when prep is to be considered in developing and high HIV prevalence countries, both sexual and non-sexual risks will need to be assessed. This is something that is not currently done, though it should be. Otherwise, the strategy is likely to be of little benefit and may do a lot of harm. Anti-African prejudice in the HIV industry is not often discussed, but it is in danger of scuppering their current favorite 'game changer'.


Tuesday, September 6, 2011

Public Funding Disappears into Private Black Hole

Burundi is not the first African country to run short of antiretroviral drugs and it is unlikely to be the last. Apparently, the shortage has already been blamed for 20 deaths. Only just over 40% of Burundians in need of the drugs are currently receiving them. In addition to sickness and death, shortages of the drugs can give rise to resistance to the only antiretrovirals that are affordable to Africans.

The shortage is attributed to a serious drop in donor funding. But even a change in emphasis in donor funding could have a similar effect, for example, if it were decided that PrEP for HIV negative people could compete with ARVs for HIV positive people in the race for funding.

Meanwhile, other research shows that earlier treatment may result in reductions in HIV transmission. The claims made about the effectiveness of earlier treatment (and more people treated) are controversial because they are based on a best case scenario. However, pharmaceutical industry mouthpieces such as AVAC are playing down any possible worries that may be raised by a fairly compliant HIV industry, led by UNAIDS.

According to the head of UNAIDS, Michel Sidibe, 'treatment is prevention', a favored soundbite of the industries that stand to profit most from the HIV pandemic. Which competing interests will be benefiting from dwindling funds is not clear, though it is unlikely that any of the current beneficiaries will be any less well off.

Interestingly, the EU is busily trying to scupper any chance that drugs, formerly unaffordable to everyone, still unaffordable to those in high prevalence countries, might one day be priced at a level that can allow all those who need them to afford them. The EU wants India, the producer of the cheapest generic drugs, to sign an agreement that will prevent them from continuing to do so.

Sidibe also makes a common claim about HIV funding, which dwarfs funding for all other health areas in developing countries: he tries to include other diseases such as TB along with HIV as a possible target of the funding. However, there is a serious TB epidemic in many African countries that is quite separate from HIV, though the two overlap somewhat.

TB is another disease where drug resistance is a very serious problem, probably because it is targeted in  relative isolation from other diseases and from the conditions that give rise to serious epidemics and health problems. But it also makes a lot of money for the pharmaceutical industry and is likely to be a significant cash cow in the future.

I guess we should never expect public money for health or human rights to be prioritized over the need of multinationals to increase their profits at all costs.


Saturday, September 3, 2011

HIV Continues to Enhance Pharmaceutical Companies' Profits

Though it doesn't stop the vigorous campaigning by Gilead to fast-track the approval process for it's Truvada antiretroviral drug for use as pre-exposure prophylaxis, little enough is known about the consequences of a large scale PrEP program. But also, the results of trials so far are far too poor to support widespread use.

The Aids Healthcare Foundation, who are opposed to this fast-tracking, have also highlighte another serious consequence. A serious black market in Truvada has emerged and one US state has passed a law so that the drug can only be prescribed when someone has been diagnosed as having either HIV or hepatitis.

Whatever the consequences of such market manipulation in the US, the same phenomena in developing countries could be very serious. Most people in high HIV prevalence countries receive medication paid for by donors. There is no current funding for PrEP. Therefore, drugs people are not receiving free of charge could rapidly increase in value in a black market.

The ethical problem of supplying a drug that is in short supply to people who are not HIV positive has not been addressed. But the ethical issue of creating a run on a drug that is keeping many people alive, just so some people can try out a HIV prevention strategy that is very unlikely to give them much protection, is also in serious need of consideration.

New HIV infections are not a problem for Gilead, far from it, they are all very welcome news. The development of resistance to cheap drugs is even more welcome as revenue from each 'customer' increases by as much several hundred percent.

Even a few deaths will not put much of a dent in profits, considering the customer base is being increased from a few million HIV positive people to a possible several tens, or even hundreds of millions of HIV negative people added to the current highly lucrative market. The article notes that the drug generated $2.6 billion in revenue in the last year and use of Truvada as PrEP could add anotehr billion to that.