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.
Showing posts with label iatrogenic. Show all posts
Showing posts with label iatrogenic. Show all posts

Tuesday, November 26, 2013

HIV Drug Regimes: the Good the Bad and the African

The reactionary (or 'mainstream', if you prefer) view of HIV transmission in African countries is that it is predominantly a result of 'unsafe' sexual behavior. Early interventions to reduce transmission included exhortations to 'abstain' from sex, to be 'faithful to one faithful partner' (or something like that) and to use condoms (an approach that later became known as ABC). Most people didn't know what words like 'abstain' and 'faithful' meant, but they became very good at repeating them until other interventions were dreamed up.

Like 'ABC', more recently touted interventions such as mass male circumcision and pre-exposure prophylaxis (or PrEP; the use of antiretroviral drugs by HIV negative people with the expectation of reducing the risk of infection), also depend on replacing some kind of 'unsafe' behavior with some other kind of behavior, deemed to be safe, or safer, or fervently hoped to be safer. Both circumcision and PrEP require that people also adhere to the strictures of the ABC approach (and if the name sounds paternalistic, that's exactly what it is).

Ever-paternalistic when writing about Africa, the BBC has heard that "some sex workers are having unprotected sex - and taking antiretroviral drugs afterwards to cut the infection risk". This is called post-exposure prophylaxis, or PEP. It has long been available in developed countries to people who are accidentally exposed to HIV, through their occupation, as a result of sexual assault, etc, although it is probably not as widely available in high HIV prevalence countries with inadequate health services, low levels of education and poor drug supply systems.

The BBC article is claiming that sex workers should be using condoms, but sex workers themselves are pointing out that they can make more money if they don't use condoms; clients are often willing to pay more. Most sex workers don't have the massive number of clients that media outlets such as the BBC have reported in the past, so they need to get as much money as they can each time they do get a client. The BBC is also 'concerned' that sex workers are using PEP too often; some say the drugs should only be used a maximum of once a year, otherwise they may cease to be effective.

In contrast, those touting PrEP can't speak highly enough of the use of drugs to reduce the risk of HIV transmission (as a look back through previous posts on this blog will show). Trials of such drugs are promoted in frequent press releases, perhaps in the hope of receiving the customary spontaneous standing ovation that some announcement must receive at every AIDS conference. The media generally picks up the press releases and spreads them far and wide, sometimes embellishing them with an extra layer of gilding.

PrEP and PEP are different. In general, PEP is taken after exposure. PrEP is taken before exposure by a person who faces a high risk of infection, or who is thought to face a high risk (which is just about every sexually active person in high HIV prevalence countries). But there are different versions of PrEP, daily and intermittent. The daily version involves taking the drug every day; but the intermittent version is taken just before sexual intercourse, or even just after.

Both versions require strict adherence to the regime, but it's clearly a lot easier to take a drug just before or just after a specific event than to take a drug every day because you or someone else considers you to face high risks of infection. Intermittent PrEP is still being studied, but the general tone of Big Pharma press releases about PrEP is that it is a great thing, that trials are doing very well, and that if people (and governments) will just pay their exorbitant prices, everything will be great. Strangely, the tone used about PEP is usually far more measured; perhaps PEP is just not lucrative enough as a market?

But the BBC can't resist the temptation to point (or at least wag) their finger. If people in African countries are infected, it's because of their behavior. If interventions don't work it's because of people's behavior. If drugs don't work it's because of lack of adherence. If people don't appear to be following instructions it's because they are failing to 'adhere to the regime'. If people are infected and know it wasn't because of their sexual behavior they are said to be 'under-reporting', or simply lying. Etc.

You get the picture. We are clever and they are not. Some people writing on the subject are even happy to use the word 'stupid', because the 'good AIDS/bad AIDS' dichotomy didn't disappear in the 1980s, as it should have. It lives on in the media, in popular books about AIDS and various other sources. There are also different drug regimes available for the good and the bad, those who were infected 'by accident' and those who are 'reckless'.


allvoices

Sunday, November 17, 2013

Could PrEP be in Competition with Mass Male Circumcision Programs?

After years of trying to create a market for pre-exposure prophylaxis (PrEP) pills, such as Truvada, Big Pharma has turned to their favorite mass marketing ploy: dumping their products in African countries that are starved of health funding. Of course, why wouldn't they dump them in Africa, won't they be paid for with donor funding?

An article in Kenya's The Star entitled "Kenya: 'Wonder Pill' for Risky Sex On the Way" takes the unusual step of raising some difficult questions about PrEP, rather than repeating the Big Pharma press release, despite a shaky introduction. The article continues "Kenyans involved in risky sex behaviours will soon get a 'wonder pill' that can prevent HIV infections. Experts say Truvada, which some call the 'new condom', can reduce chances of catching HIV but there are fears the drug may be misused by the youth".

What, exactly, would constitute misuse of the drug? If it can cut the risk of infection by "up to 75 per cent if one faithfully swallows it daily", what could go wrong? Well, as the article eventually reveals, most people don't swallow drugs daily and most people can not expect 'up to 75%' reduction in risk. That figure is not even from a randomized controlled trial, but from a 'sub-group' study, where the best results are used to exaggerate the level of protection people, in (comparatively) strict trial conditions, may expect. Outside of that sub-group, and outside of drug trial conditions, risk reduction is far lower.

It's odd that such reports talk about studies and proofs for something that they then refer to as a 'wonder pill', a 'new condom' and talk of 'up to 75% protection' (although that's a bit weak compared to the term 'invisible condom' used by those marketing mass male circumcision), and the like. These are PR buzzwords, not scientific findings.

It is said that PrEP programs intend identifying those most at risk of being infected, such as sex workers, intravenous drug users and men who have sex with men. This will be a departure from vilifying these already stigmatized and criminalized groups; it remains to be seen how much donor funding will actually be spent on these groups to provide them with PrEP, given that it has been so difficult in the past to provide them with condoms, injecting equipment and even basic sex and sexuality education.

As the article says, Truvada is expensive, and it has made billions of dollars for Gilead. So it's worth their while pushing as much of the stuff as possible in countries with high HIV prevalence while the patent guarantees that their product will face little competition. By the time the patent expires the likes of Bills Clinton and Gates will surely have set up some program whereby the drugs can continue to be purchased at inflated prices.

The article makes the important point that nearly 1 million HIV positive Kenyans currently need antiroviral drugs just to keep them alive. So why would donors want to provide these same drugs to people who are not yet infected with HIV (aside from an obvious desire to enrich big pharma)?

Oddly enough, a cost effectiveness study makes its estimates using existing levels of male circumcision and antiretroviral therapy. This means that the three multi-billion dollar programs will be in direct competition with each other for funding, and each one will be trying to claim that any drop in HIV incidence is a result of their work. The study also seems to assume far higher levels of success than have been achieved so far. But that's big pharma for you.

While Gilead and other pharmaceuticals can gain a lot from any increase in antiretroviral therapy and PrEP programs, they may not stand to gain from mass male circumcision programs. Their assumption that their PrEP programs will be cost effective only in countries where circumcision levels are low suggests that by the time their product may be approved, the circumcision programs will already need to have failed, some time around 2015.

Worries that people may use PrEP as a kind of recreational drug, so they can dispense with the use of condoms when they are engaging in sex with people who may face a high risk of being HIV positive are not very convincingly addressed; nor are worries that overuse and misuse of antiretrovirals, either for HIV positive people or as PrEP, are brushed aside, with remarks about "government policy" and making the drug available "in form of a package that probably includes HIV testing and other prevention methods".

I seem to remember condoms, circumcision, ABC and various other programs being made available in the form of a package, without that leading to extraordinary results. But it will be interesting to see if PrEP will erode some of the funding currently being made available to, or earmarked for, mass male circumcision programs.

Circumcision programs stand to rake in billions for the big providers, but widespread use of PrEP would be worth far more. It's unlikely that a full scale version of both programs could co-exist; they are not mutually exclusive, but their cost effectiveness is predicated on their being the only or the main program in high HIV prevalence countries.

Whether one program displaces another, or whether they all get funded, the losers will be people in high HIV prevalence African countries, which will continue to suffer from under-funded health and education sectors. They will continue to be a mere 'territory' for sales reps, who will continue to carve things up in ways that should be very familiar to us by now.

allvoices

Saturday, July 20, 2013

Treatment Action Group Raises Concerns About Thai PrEP Trial

The media reacted predictably when it was announced that a pre-exposure prophylaxis trial in Thailand showed some promise in reducing HIV transmission among intravenous drug users (IDU). However, many raised concerns throughout the course of the trial about how it was being conducted. One concern was that clean needles were not provided to trial participants, even though these are known to be the best means of reducing transmission among IDUs. But there were other serious issues that put a question mark over the value of the trial.

Another observation is that "the extent to which tenofovir protected against parenteral versus sexual exposure is unknown". The extent to which sexual versus parenteral exposure may have been involved was never questioned in many other PrEP trials, in mass male circumcision trials and in trials of numerous other HIV prevention interventions. Many HIV related trials fail to account adequately for modes of transmission, assuming that the virus is almost always transmitted sexually, often despite evidence to the contrary.

I'm just curious to know why these concerns have been raised by the Treatment Action Group about this trial in particular, when serious concerns about some other HIV prevention trials don't seem to be heard much, at least, not without attracting accusations of 'denialism' and similar ad hominem responses.

allvoices

Saturday, October 20, 2012

Give ARVs To Those Who Need Them; PrEP Can Wait


It's been a while since I've written anything about PrEP and it's hard to keep up with two blogs. But there have been a few articles on the subject. One, and I've only seen the abstract, finds that PrEP has high acceptability but that adherence and use are more challenging. This may be a reflection of the sheer idiocy of throwing drugs at a disease that is treated in almost complete isolation from all other diseases, from the conditions in which people live, from their overall health status, etc.

Interestingly, people on PrEP ran the risk of being perceived as HIV positive, giving rise to stigma, rumors and relationship difficulties. A paper about lymphatic filariasis reports that people have difficulty understanding why they should take pills for a condition for which they have no symptoms, and also why they should take the same pills for what they see as two different conditions (swollen legs and swollen testicles).

The authors of the PrEP article note that "adherence was challenged by complexities of daily life, in particular post-coital dosing adherence suffered from alcohol use around time of sex, mobile populations, and transactional sex work". The research into giving antiretroviral drugs to HIV negative people took place in Kenya, a country where many HIV positive people with a critical need for the drugs are not receiving them, and where many babies are still being infected by their mothers (or perhaps through some other route that antiretroviral drugs will not be able to address, such as through unsafe healthcare).

A review of a mathematical modelling study of PrEP mentions the ethical problems of rolling out such a program in a country where many HIV positive people are not yet on antiretrovirals. The article finds that the strategy would be cost effective in a middle income country, such as Peru, but only if it was highly targeted. However, this is where PrEP and most other HIV interventions come unstuck in African countries. HIV in high prevalence African countries is characterized by not disproportionately affecting just a few easily identifiable groups. While prevalence is high in certain groups, the largest groups of HIV positive people don't have obvious sexual risks that could easily be targeted. Also, these groups are far too large for any African country to afford.

What I don't really understand about PrEP though, is why it is necessary at all. Proponents of the use of antiretroviral drugs in as many scenarios as possible (early treatment, lifetime treatment for women receiving prevention of mother to child treatment, etc) tell us that someone on ARVs is not very infectious. If PrEP could be targeted at people who are thought to be at risk, targeting those who put them at risk would seem like a much better prospect; that is, targeting people who are already HIV positive. They are a far smaller group, for a start, and this would be a good reason for putting all HIV positive people on ARVs as soon as they have a clear clinical need for them.

allvoices

Saturday, July 21, 2012

PrEP is Win-Win for Big Pharma, Lose-Lose for Ordinary People

When a PrEP trial produces poor results, the reaction is often to point the finger at the patient: they didn't take the drugs regularly, 'adherence' was low, etc. The irony of this is that people thought of as good candidates for PrEP are often those who have not successfully modified their sexual behavior, or have shown themselves unwilling to do so. If they will not or can not modify their sexual behavior, why would they be more willing or able to modify their drug taking behavior?

Some drug trial reports parcel up the high achievers and exclude the low and medium achievers and call it a 'sub-study' or something similar. But the point of a randomized controlled trial is to make it clear what kind of result can be expected of people taking part, not what kind of result can be expected if everyone behaved as drug manufacturers would wish them to. Given that people don't behave in real life as they do during drug trials, the results for strategies such as PrEP so far have been somewhat encouraging, but not good enough to roll out the strategy.

Even with PrEP, people are encouraged to engage in safe sex, to limit their number of partners, to use condoms, etc. If they can't or won't do some or all of those things, PrEP will not be very effective; but it may not have any positive impact at all. Those behind the trials and those producing the drugs are anxious to portray the strategy as tested and proven, but it is most definitely not, not yet anyhow. One of the main exponents of the strategy tries to persuade us that PrEP is the way to go, but some of his readers are clearly not convinced. And the opposing case raises additional concerns about PrEP, referring to the strategy as 'grasping at straws'.

In countries where HIV prevalence is very high and transmission is highest among low (sexual) risk groups, those engaging in heterosexual sex with one HIV negative partner, PrEP is not going to be feasible. Those who face the lowest risk, but are paradoxically the highest risk group in Modes of Transmission Surveys, are unlikely to be targeted by a PrEP campaign.

And given that the majority of HIV positive people in need of treatment are still not receiving it due to cost, infrastructure, political and other reasons, it would be odd to offer the same drugs to people who are still HIV negative. It would seem far better to establish what exactly the risks are and address those risks before throwing yet more drugs at the problem. But PrEP is the way to go if you want to sell lots of drugs to healthy people; if that doesn't work, you'll then have lots of sick people to sell even more drugs to.

allvoices

Saturday, June 23, 2012

Truvada Manufacturer Gilead Stops Funding to Critics


The Aids Healthcare Foundation (AHF) provides healthcare for HIV positive people and advocacy in the broader field of HIV health. In that capacity, the AHF has criticized the pharmaceutical company Gilead Sciences on a number of issues, including drug pricing policies.

But in addition, AHF has questioned the use of Gilead's Truvada as a pre-exposure prophylaxis (PrEP), a pill to be taken by HIV negative people to give them some protection from HIV infection. It could be taken, for example, by someone whose sexual partner is HIV positive. However, PrEP is not as effective as using a condom and it doesn't protect against other sexually transmitted infections.

More importantly, using a drug like Truvada can give rise to the development of drug resistant strains of HIV, especially in users who are unknowingly infected when they start taking the drug or who unknowingly become infected while taking it. AHF have argued that every time someone gets a prescription for Truvada, they should also be able to show that they have been tested for HIV and the result is negative.

Drug manufacturers are not known for their tolerance of public accountability; as a result of AHFs actions, Gilead have stopped their funding to AHF. This is particularly unfortunate right now because approval for Truvada as PrEP, which was expected to be rushed through the usual regulatory procedures, has now been delayed so that the requirement for a negative HIV test be stipulated. But it's likely that Gilead will continue to lobby for the right to aggressively pursue their own ends at the expense of public health.

The increasing dependence on drugs with outrageously high prices is worrying even in a wealthy country like the US. But as the country has the highest HIV prevalence in the Western world, it would be an even bigger threat to the country's public health systems if widespread resistance to Truvada were to develop. As well as resistance developing in an individual taking the drug, resistant strains of HIV can also be transmitted to others.

Also of concern is that, up until now, HIV drugs have been used by HIV positive people. The use of the same drugs by people who are HIV negative should be raising questions in people's minds about how far public health should go with what is effectively medical treatment for perfectly healthy people.

They may even ask how far it is possible for public health to go; the number of healthy people should, hopefully, far outnumber the number of sick people; it's undoubtedly a great market. But some level of drug resistance is inevitable. So are companies like Gilead stealthily creating new markets for even more costly second line drugs by vastly increasing the number of healthy people taking Truvada?

allvoices

Saturday, May 12, 2012

Experts Unambiguously Opposed to Saying the Wrong Thing


Apologies for the lack of posting this year but I have had enough work keeping my other blog going. The subject of PrEP and related issues do also crop up there, though.

Daily use of Truvada has been backed for pre-exposure prophylaxis use by a panel of 'experts', which generally refers to people who are so well paid to say the right thing that no one else will disagree with them. It's likely that this use of the drug will soon be approved by the FDA. I wasn't able to find a register of the 'experts'' interests but I'm sure it would make interesting reading.

If approved, the drug will be prescribed for HIV negative people who are thought to be at high risk of being infected sexually, which generally refers to men who have sex with men in Western countries. The drug is not being considered for use by intravenous drug users. It is also unlikely to be of much value for commercial sex workers in wealthy countries as they are rarely infected unless they are also intravenous drug users or face other serious risks.

This suggests that PrEP is unlikely to be effective in high HIV prevalence developing countries, where high risk groups are not easy to identify. In many African countries, the bulk of infections among adults occur in married people and those in long term relationships, who don't face very high sexual risks. In other words, the drug is of little use as PrEP where it is most needed. But I'm sure that won't stop Big Pharma from lobbying the right people so that the potential tens or hundreds of millions of Africans can be exploited.

The process of palming off useless but extremely expensive drugs with potentially dangerous side-effects on Africans has been eased by years of publicity for the dominant HIV transmission paradigm, which says that almost all HIV in African countries is transmitted through heterosexual behavior. The fact that the paradigm is seriously challenged by empirical data has done little to influence policy, which concentrates on the politician, religious leader and media friendly process of wagging fingers, pointing fingers and poking fingers into the many HIV fuding pies.

Opposition from groups who claim to represent the interests of HIV positive people has almost all been taken care of in the time honored fashion of paying off anyone who speaks out of turn (or rubbishing anyone who won't take payment). A rare voice of dissent comes from the Aids Healthcare Foundation, which has consistently opposed the current trend of rushing into practices which have little empirical backing, but which mysteriously receive full backing from 'experts'.

Pharmaceutical front group Aids Vaccine Advocacy Coalition (AVAC), predictably, blow the trumpet for PrEP; pharmaceutical products ostensibly produced to treat illness would never have become as profitable if they were only used by sick people. But the UK's Nick Partridge puts his finger on the problem, probably inadvertently: "But we need to know if people at highest risk of infection are prepared to take a pill every day and whether there would be an increase in risk-taking behaviour which could outweigh the prevention effectiveness of Truvada."

The truth is, we don't know who is at highest risk in high prevalence countries, we know that most will not take the pill every day and it's very likely there will be an increase in risk-taking behavior, especially where people opt for PrEP because they know (or even think) they are at risk.


[For more about non-sexual HIV transmission and male circumcision, see the Don't Get Stuck With HIV site.]

allvoices

Sunday, February 19, 2012

Tenofovir Products in Search of a Market

A few days ago, an article appeared on AidsMeds.com about the drug Tenofovir being associated with an increased risk of irreversible kidney disease, which does not reverse even when the drug is no longer taken. Tenofovir is one of the main ingredients in a vaginal gel developed to reduce the transmission of HIV, although a recent trial was stopped early because the gel was found to be ineffective. Another trial of Tenofovir taken orally as pre-exposure prophylaxis was also stopped early as it was clear it would not be possible to demonstrate a difference in effect between the drug and a placebo.

Despite these findings, Poz.com reports that the US Food and Drug Administration (FDA) has accepted an application from the makers of Tenofovir, Gilead Sciences, to give a priority review of the use of the drug, in combination with emtricitabine, to be marketed as Truvada. Despite some less favorable findings about Tenofovir, the more favorable findings led to immediate calls for application for use as PrEP to be fast-tracked.

In addition to the above worries about Tenofovir, widespread use of PrEP is also likely to give rise to drops in use of condoms. This possibility is denied vigorously by defenders of PrEP, and some data has been produced to support that defence. But like male circumcision and the hormonal contraceptive Depo Provera, people tend not to think about dual protection against both HIV and unplanned pregnancy.

Interestingly, while injectable versions of Depo Provera and similar methods are said to be 'female controlled' relative to the oral version, this objection doesn't appear to be used or alluded to by proponents of PrEP or vaginal gel.

A paper has been published discussing these diverging trial results and the authors pay particular attention to adherence to the drug regime, which needs to be very high. The authors mention identifying "optimal populations for PrEP"; but they may find that these populations are least likely to need the drug. It's all beginning to sound like a product in search of a market; but where would Big Pharma be if it never took that approach?

allvoices

Saturday, February 4, 2012

Apologies for Lack of Posting


It's been some time since I have been able to write a post for this blog but I will get back to it as soon as possible. I also write about the lunacy of prohibitively expensive and purely technical approaches to what are public health and development issues on my HIV in Kenya blog and also on the Don't Get Stuck With HIV blog and website.

allvoices

Monday, December 12, 2011

Treatment As Prevention: Dream or Nightmare?

In the light of current enthusiasm for 'treatment as prevention (or 'is' prevention or some other permutation)', it's sobering to read an article from the US entitled 'Only 28% of HIV patients have condition under control'. The idea of treatment as prevention, sometimes referred to as 'test and treat', is that it will be feasible to test about 80% of an entire population, not just once in a while, but regularly, perhaps once a year or more. Upon being found HIV positive people will receive immediate treatment, regardless of clinical stage.

The US spends over $7,000 per capita according to WHO estimates for 2009; that's over 15% of GDP. Tanzania, in contrast, spends $57 per capita, 4.5% of GDP. So if only 28% of HIV positive people in the US are rendered unlikely to transmit the virus to others through having a low viral load, at least through (safe heterosexual) sex, and about 20% of those infected don't even know they are positive, where does this leave countries like Tanzania?

Figures for how many Tanzanians are on antiretrovirals vary a lot and are vague; they don't make it clear what percentage on treatment have the virus under control. Quite a lot of people said to be on treatment are lost to follow-up every year. Many die or move to another area, but this also suggests that numbers on treatment are overestimated as some are registered in more than one place. The majority of HIV positive people in Tanzania are not on treatment and a majority of the population have never been tested for HIV. A large number of people who have never been tested are estimated to be HIV positive.

I just don't feel convinced that the money is going to be stumped up to test tens of millions, perhaps hundreds of millions of people every year for the foreseeable and to treat tens of millions for several decades to come. But perhaps I'm just a sceptic (or 'skeptic' if you're in the US).


allvoices

Monday, November 28, 2011

Tenofovir Vaginal Gel Trial Stopped Because It's Ineffective

The Microbicide Trials Network (MTN) have announced that Tenofovir gel will no longer be used in the current VOICE trial (Vaginal and Oral Interventions to Control the Epidemic) shortly after the same decision was made about the oral version. Both arms of the trial have been stopped for the same reason; neither are any more effective than a placebo. Trials of Truvada, a combination of tenofovir and emtricitabine, will continue for the moment.

Incidence, the rate of new infections, was extremely high, at 6%. I wonder if the trial has got any closer to figuring out just why HIV transmission is so high among study participants? For instance, were sexual partners tested and were their HIV types matched? Were possible non-sexual HIV exposures investigated, for example, through unsafe healthcare, traditional healthcare, cosmetic practices, or any others?

All the talk about 'fast-tracking' approval of tenofovir by the US Food and Drugs Advisory for possible production by 2014 that we heard so much of just a year ago has been replaced by the kind of silence we've come to expect from results that can't even be dressed up to look a little bit positive. With viable gels and PrEP pills so far in the future, it might be a good idea to put into effect some low technology (though far less lucrative) HIV prevention programs.

The full results of VOICE are unlikely to be available for some time, perhaps another year or two. But if good data is collected on non-sexual transmission, the thousands of participants will not have wasted their time completely. It won't be much consolation for the hundreds of people whose infections were not prevented, nor the hundreds of thousands of new infections that will occur elsewhere in the meantime, but everyone will benefit if a little less attention is paid to their sex lives, which may not be as relevant as orthodox HIV theory suggests.

Mitchell Warren, the Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC, a front group for the HIV pharmaceutical industry), has expressed disappointment. One researcher is reported to have said "the failure of one method in one trial did not mean that the trial, or the idea of microbicides, had failed." Which is quite true. The failure could be for entirely different reasons, incorrect and unwarrented assumptions about the relative contribution of sexual transmission in serious epidemics being just one.

allvoices

Thursday, November 24, 2011

Treatment is Not Prevention, but it is Far More Lucrative


It's a relief to hear that there are some people working with HIV who are willing to speak out against the apparent assumption that treatment is prevention, that all we need to do is substantially increase the number of people taking expensive antiretroviral therapy (ART) for the rest of their lives, regardless of the known consequences of such a strategy, and HIV transmission will magically decline and eventually disappear.

Alison Rodger, Andrew Phillips and Jens Lundgren recommend that before adopting ART as a prevention policy, we need to assess the risk of HIV transmission through unprotected sex (ie, without a condom) when the viral load is undetectable. So far, research has revealed that transmission could be unacceptably high under such circumstances, but neither the media nor the academic hype around treatment as prevention has alluded to this.

Xiaohua Tao, Dan Shao and Wei Xue call for an assessment of how a policy of treating HIV positive people at an earlier stage of disease progression would affect their sexual behavior. They point to evidence that use of ART increases risky sexual behavior. They also express worries about the development of resistance to ART, which is one of the known consequences alluded to above.

Enthusiasts of the treatment as prevention strategy, Myron S. Cohen, Ying Q. Chen and Thomas R. Fleming, accept that the benefits of ART are unknown where condoms are not used as part of the strategy. They also note the frequent occurrence of pregnancy and sexually transmitted infections (STI) among trial participants, which suggests that self-reported sexual behavior was not so accurate, or that condoms are a lot less effective in reducing STI transmission and pregnancy than we are led to believe.

Essentially, Cohen and colleagues are a bit vague with one of the real worries about a treatment as prevention strategy: the lack of clarity about how HIV is transmitted so rapidly in only some countries. The orthodox view is that heterosexual sex is responsible for 80-90% of transmission. But why should a virus that is difficult to transmit through penile-vaginal sex be transmitted so rapidly in certain populations? Do they all secretly engage in anal sex? Or are there non-sexual risks that some of them face?

Uganda is an interesting case in point. The orthodoxy gather up lists of 'most at risk' people, men who have sex with men, intravenous drug users and the like. They also add in sex workers, truckers and other groups who are said to be vulnerable because of their 'mobility', whatever that may mean. But there is always the assumption that heterosexual sex is the key. Yet none of these circumstances explain massive rates of transmission in some countries, where most people don't fall into any of those groups said to face high risks.

Indeed, the majority of transmissions in Uganda and other countries are among people who do not face high risks, they fall into low risk categories, even by the strictures of UNAIDS and others in the industry. Don't these astute people notice the contradiction in their claims, that most HIV transmission occurs among low risk people, those who do not have high risk lifestyles? What is it about Ugandans? Is it their sex lives, their sex organs, or something else?

It's not just treatment as prevention or any other smug strategy that will fail if we don't make it clear how HIV is being transmitted, why it is being transmitted amongst people whose ostensible risk behavior levels are low and why doling out ever increasing amounts of drugs to ever increasing numbers of people should make any difference; because, so far, for every person put on drugs, two become newly infected. If putting 6 or 7 million people on ART doesn't reduce transmission, why should doing so with 16 or 17 million, or more?

Treatment is not prevention and until the actual modes of transmission, rather than assumed modes of transmission, have been properly assessed, HIV prevention efforts in Uganda and elsewhere will continue to be as unsuccessful as they have been so far. The fact that ART keeps HIV positive people alive does not mean that it will keep HIV negative people negative. It may help, but it is not enough.

[For more about non-sexual transmission of HIV through unsafe healthcare and cosmetic services, see the Don't Get Stuck With HIV site and blog.]

allvoices

Saturday, August 27, 2011

Don't Get Stuck with HIV: Medical and Cosmetic HIV Transmission

Anyone truly concerned about preventing HIV might wish to know more about non-sexually transmitted HIV, which is a lot more common than UNAIDS and the HIV industry would like us to believe.

The purpose of this new website, "Don't Get Stuck with HIV", is to help people protect themselves from from infection during medical and cosmetic procedures, such as getting an injection, having one’s head shaved, getting a tattoo or pedicure, or going to the dentist. Check through the A-Z of site content to see if you might be taking any risks!


If you have any comments don’t hesitate to get in touch. There is a comment form on every page. We will try to get back to you, and we will consider every comment, but we can’t promise to comply with every request!

Also, you can sign up to receive updates, as and when they appear, by using the email subscription ‘Sign me up!’ button on the right hand column of every page.

allvoices

Friday, January 21, 2011

Crumbling, Staffless African Health Systems Bombarded With Drugs

With all the hubris about drugs and new medical technologies, you'd think that hospitals in East African countries are ready to save their whole populations if they could just get hold of the latest drugs. This is far from the truth.

Drugs that arrive in the country often don't get distributed and expire before they are used, they get distributed to the wrong people and disappear into the black economy, they are prescribed by people who don't know how to prescribe them properly, they are already useless because of widespread resistance, etc.

Even antiretroviral drugs have a bit of a mysterious time once they reach here. Some people are kept alive by them but the majority of people who need them don't yet get them. Another mystery is how many people die while on the treatment, or why treatment sometimes fails where it would have been predicted to succeed. And a huge number of infants are still infected by their mothers, despite promises that this phenomenon will soon be phased out.

Despite all the money being thrown at HIV, and very little else, health services just can't cope. There isn't the infrastructure or the level of skill required to ensure the health of most people and many, even those with HIV, are dying of easy to treat illnesses.

It's good to see an admission that the problem is at least partly with health systems but it would be even more comforting to hear that big funders are doing more to improve health systems than just talking about it. Strategies like PrEP, treatment as prevention, mocrobicides, etc, will be of little use if they don't get to people or if they are not used optimally when they do.

Which reminds me, why do countries that are so short of infrastructure, medical supplies and especially personnel think that mass male circumcision is so important when their health services are in crisis and have been for some time?

Apparently Tanzania has circumcised a few thousand men but so have Uganda and other countries. And Kenya claims to have circumcised 250,000 in a very short space of time. I'm glad I'm not one of the, having seen the state of some health facilities in East Africa.

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Sunday, December 5, 2010

In the Absence of Promiscuity, PrEP is Useless

An IRIN article ends with a comment from Dr Helen Rees: "I'd ask why we're doing these studies in these countries at all if we're not going to implement any of these interventions,...I find that unethical." What I find unethical is that these interventions all assume that HIV is primarily transmitted sexually, despite evidence to the contrary.

However, these drug trials have shown one very significant thing: most African people don't have sex a great deal. Their sexual behavior is not extraordinary. And Modes of Transmission Surveys for Kenya and Uganda show that it is ordinary people in long term monogamous relationships that contribute the vast majority of HIV infections in those countries. And yet HIV transmission rates are extraordinarily high.

If you had unlimited amounts of money, you could unleash PrEP on whole populations. It would be a stupid and dangerous thing to do, but if you think, as the HIV mainstream do, that most Africans have enormous amounts of high risk sex all the time, you might think it would be worthwhile.

But there isn't even enough money to supply half of the people globally in need of antrietroviral (ARV) drugs with treatment. The majority of people globally have never been tested for HIV. The majority of HIV positive people globally don't know their status. And PrEP would require that everyone, or most people, be tested as much as four times a year.

PrEP advocates need to get things in perspective. We know a lot less about HIV transmission than we should, given the amount of study that has been done over the years. We are not in a position to consider HIV prevention programs that involve vastly higher numbers of people (and finance) than current programs, which are struggling, despite claims to the contrary.

It's a sobering thought that HIV transmission rates are still very high in countries with very large ARV programs. Also, death rates are very high among people on treatment. People are dying, not because they are HIV positive or because they have AIDS, but because they have preventable and treatable conditions that are just not being treated.

Developing countries with high HIV prevalence have low levels of education, health, infrastructure and many other factors that are intimately related to rapid HIV transmission. Churning out drugs in ever increasing quantities is not going to change things much, especially if evidence that HIV is not primarily sexually transmitted continues to be ignored.

What we are ethically obliged to do is to be frank and honest about sexual transmission of HIV: we don't know why transmission rates are hundreds of times higher in some parts of some African countries than they are in most countries, developed and undeveloped. Therefore, we cannot continue to base most prevention programs on the assumption that Africans have superhuman amounts of sex.

PrEP may turn out to have some use but we have, as yet, no idea what that would be.

[For more on the false hypothesis about African promiscuity, see my other blog.]

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