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.Pre-exposure prophylaxis (PrEP) involves putting HIV negative people on antiretroviral drugs (ARV) with the aim of protecting them from HIV infection. read more..
Thursday, 9 August 2012
Randomized Controlled Trial-Drug Manufacturers-Sexual Behavior-Drug Trials
Friday, 20 July 2012
Transmission Of Hiv-Male Circumcision-HIV
My first big shock when I started to follow HIV related issues in East Africa was that it was assumed almost all Transmission was sexual in Africa (though nowhere else). Then, to 'work out' how this could possibly generate such massive epidemics, there was also the tendency to go from the number infected, or said to be infected, to the absurdly high levels of unsafe sexual behavior that would be needed to explain high levels of heterosexual transmission of HIV. There has never been any evidence that unsafe heterosexual sex alone could explain Africa's worst HIV epidemics. But all the 'work' to prevent infection appeared to concentrate on sexual transmission.
If not all HIV is transmitted sexually, many interventions that target sexual behavior, whether levels are real or assumed, will fail. Abstinence and other associated campaigns didn't even sound plausible before they were implemented, but enormous amounts of money was ploughed into them. Some equally dubious interventions were dreamed up and most probably also had little positive effect; as for any negative effects, these are unlikely to have been measured, let alone alluded to in the copious self-congratulatory literature that has emerged from what became the extremely lucrative HIV industry.
When circumcision was mooted as a possible intervention, it seemed to suffer from the above problem; it would, at best, protect against heterosexual transmission; it would not protect men who have sex with men, infants who are infected by their mothers or intravenous drug users. Indeed, it turned out that it wouldn't protect women either, and probably increases transmission from men to women. It will not reduce non-sexual transmission of any kind, including that through unsafe healthcare or cosmetic practices. Worse, in the sub-standard health facilities that ordinary Africans are forced to use, mass male circumcision programs might add to the problem, with men being infected in the health facility where the operation is carried out.
But those receiving circumcision related funding continue to insist on the effectiveness of such programs, shouting down any opposition, churning out figures which could be interpreted to show that male circumcision reduce transmission from women to men, but never actually engaging with the opposition. There are now so many problems with male circumcision as a strategy that the whole exercise to circumcise between 22 and 38 million African men should be suspended. There is so much disinformation and consequent misunderstanding that the campaign is unlikely to do any good and is in serious danger of doing a lot of harm. At best, it is just another neo-colonial excess of the kind that probably ensured that HIV would become the pandemic that it now is.
Kenya's Nairobi Star is currently doing a great job adding to the obfuscation that seems to pass for scientific journalism. The article 'Study Claiming Cut Does Not Inhibit HIV Rejected' makes a shaky start by incorrectly suggesting the study was not published or that its findings were refuted, or were even addressed by those promoting circumcision. The cited claims from the study are, in fact, correct, but they are only the tip of the iceberg. Interviewing those who would have a lot to lose if the circumcision program was suspended and asking their opinion is easy enough. But is it adequate journalism? Does the public really need more of the selective use of factoids to justify spending hundreds of millions of dollars on a campaign that is likely to be of so little benefit (at best)?
Other countries have less to say about the latest paper, one of several that has managed to get through the HIV industry's censorship process (peer review). Uganda's press has commented on circumcision from time to time, but only to beat the orthodox drum. It is claimed that 600,000 men have already been circumcised under the program since 2009, but it is unclear where this figure comes from. Natu read more..
Thursday, 14 June 2012
Child Hiv Transmission-African Countries-Sexual Behavior-Hiv Prevalence
Despite the monstrous quantities of 'unsafe' sex that Africans are claimed to engage in by UNAIDS and other HIV institutions, HIV is not at all distributed evenly. Prevalence ranges from less than 1% in some African countries, a lot less than in some US cities, to more than 25% of the adult population in others (and even 50% in some demographic groups). Even within high prevalence countries HIV is not distributed evenly. In many African countries the virus tends to be far more common in cities, close to main roads, close to health facilities, among wealthier and better educated people, etc. It is also generally far more common among women than among men.
Other research has found HIV prevalence to be higher in areas where diseases such as schistosomiasis (bilharzia) and malaria are higher. However, as these both tend to be higher among less wealthy people with lower levels of education and in rural, as opposed to urban areas, there is more than a suggestion that HIV transmission may have widely varying risk factors. Yet UNAIDS and friends tend not to dwell on most forms of non-sexual risk in Africa.
As David Gisselquist writes in the Don't Get Stuck With HIV website: "Unlike Western countries, where almost all HIV transmission occurs outside families, a lot of HIV transmission in Africa happens within families – mother-to-child and spouse-to-spouse transmission together account for an estimated 45% of new infections." Not only is a lot of HIV not transmitted sexually, but a lot is not transmitted through 'unsafe' sex. Many of these couples where at least one partner is infected have no sexual risks. Hundreds of thousands of new infections every year occur through these two routes.
In Africa, then, the main groups are those at risk of mother to child transmission and married couples, especially couples where one partner has been infected. It's as likely to be the female as the male partner, but how does the index partner become infected, the first in the couple? Sex, says UNAIDS, but sex with whom, how much sex and what kind of sex? Heterosexual sex is not an efficient means of transmitting HIV. Gisselquist is suggesting that the focus of international HIV reduction efforts in African countries should address these and other risk groups, where sexual risk is very likely to be low but HIV prevalence is high; this could cut as many as 700,000 transmissions annually.
A serious set of risk factors could arise from unsafe healthcare and perhaps even unsafe cosmetic services. It's not just that conditions in healthcare and cosmetic facilities in African countries are primitive but also that many people are not aware that such risks exist; if they are not aware of the risks, they will not know that they need to avoid them, nor how to avoid them. But if they are aware, they will also realize that a person's HIV status is not a reliable indication of their sexual behavior. This should reassure some who have been brainwashed to associate HIV with 'immoral' behavior; many women, especially, have been beaten by their partners, ostracized by their communities and even killed because of the incorrect association of HIV with sexual behavior.
The HIV industry does talk a lot about the importance of HIV testing. But they also put people off testing where being positive has such terrible consequences. If people were to know that there were other, non-sexual risks, the stigma associated with testing and with having (or being thought to have) HIV should reduce. People who know their status don't tend to take risks, neither sexual nor non-sexual; but they must also be advised of the non-sexual risks. Those who are infected non-sexually can be involved in sexual transmission just as easily as those who are infected sexually. But in the current climate of sex-obsessed HIV policies, they are unlikely to know about non-sexual risk.
Prevention of mother to child HIV transmission is vital if the mother is already infec read more..
Saturday, 19 May 2012
Pre-Exposure Prophylaxis-African Countries-Hiv Negative-HIV
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.]Pre-exposure prophylaxis (PrEP) involves putting HIV negative people on antiretroviral drugs (ARV) with the aim of protecting them from HIV infection. read more..
Tuesday, 20 March 2012
Hiv Positive-HIV Patients-Prevention
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).Pre-exposure prophylaxis (PrEP) involves putting HIV negative people on antiretroviral drugs (ARV) with the aim of protecting them from HIV infection. read more..
Sunday, 4 March 2012
Sex Trafficking-London Olympics-South Africa-World Cup
The usual rubbish that comes out in the press before a big international sporting event is back, according to the New Internatonalist: journalists throughout the 'free' press are already salivating about the '40,000 (or some such large number) forced prostitutes' who will be compelled to work during the London Olympics. The same kind of unresearched bumf came out before the World Cup in South Africa and various other sporting events, going back years. It's not even specualtion; there is nothing to support the articles but guesswork and other, equally underresearched articles from other, equally idiotic journalists.The worrying aspect of the articles before the South Africa World Cup is that the country has some of the worst figures for HIV prevalence in the world. Therefore, half a million or a million visitors (depending on which source you believe) faced a very real risk of being infected with HIV, hepatitis or other blood-borne diseases if they happened to go for a tattoo, dental treatment, medical treatment or any number of other procedures. UNAIDS, despite being aware that such risks exist, choose not to inform Africans, preferring just to warn their own employees. When it comes to Africans, their response is that 80-90% of transmission is from heterosexual contact. But in the run-up to the World Cup, they didn't even warn visitors to the country.As the New Internationalist points out, the figure is purely imaginary, probably inflated by those who feel all sex work is also sex trafficking. One of the problems with this is that there is little way of telling where the real trafficking is taking place, and therefore where to concentrate efforts to reduce it. But why traffic thousands of people for a very short event, anyway? 40,000 sex workers would barely get enough business from the Olympics attendees who happen to be male, sexually active and remotely interested in having sex with someone who has been forced into the business against their will (as opposed to those who make a choice to be sex workers, for whatever reason).There are people being trafficked, but if police concentrate all their efforts on commercial sex work, they will have difficulty identifying those who are doing it against their will. And if they think trafficked sex workers will suddenly be easy to find during the olympics, this is not going to be their 'lucky break'. But I'm sure the police know that, even if journalists don't (I'd like to say tabloid journalists but I don't think it is confined to them). Apparently there is increased police activity, with the predictable excesses that go with such measures, but let's hope they quickly realize that they have better things to do.Luckily, unlike in South Africa, there is little risk of being infected with HIV or anything else through medical or cosmetic exposure. At least, people won't face any higher a risk than patients currently do in UK health facilities. But sudden spikes in media and political interest in such issues doesn't help anyone, the women who are mistreated by the police, women and girls who happen to be trafficked, or anyone. The various illegal practices that surround sex work, which probably arise from the fact that it hasn't yet been decriminalized, are likely to continue, unaffected by the waxing and waning of these mostly trumped-up moral crusades.[For more about non-sexual HIV risks, such as through unsafe healthcare practices, see the Don't Get Stuck With HIV site.] read more..
Food And Drug Administration-Pre-Exposure Prophylaxis-Transmission Of Hiv-Favorable Findings
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?Pre-exposure prophylaxis (PrEP) involves putting HIV negative people on antiretroviral drugs (ARV) with the aim of protecting them from HIV infection. read more..
Saturday, 3 March 2012
Hiv Prevention Programs-Sexual Transmission-Hiv Transmission-Hiv Infection
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 HIVTransmission 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.Pre-exposure prophylaxis (PrEP) involves putting HIV negative people on antiretroviral drugs (ARV) with the aim of protecting them from Hiv Infection. read more..
Wednesday, 29 February 2012
Hiv Prevention Efforts-Transmission Of Hiv-Prevention Strategy-Hiv Transmission
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 el read more..