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
Tuesday, 5 June 2012
Food And Drug Administration-Aids Healthcare Foundation-Poor Efficacy-Truvada
In addition to the good work that the Aids Healthcare Foundation is doing to question the 'fast-tracking' of the use of Truvada as PrEP when it has so far shown such poor efficacy, a group of 55 US physicians have signed a letter, also urging the US Food And Drug Administration (FDA) to delay approval until further tests, which may take years, have been carried out.PrEP may be a great theory and Truvada may be a great drug. But there is little to get excited about yet. If effectiveness in the real world (as opposed to efficacy in carefully controlled trial contexts) can reach a reasonable level, which would be a lot higher than the unimpressive 44% found in the iPrEX study, then it will be time to consider the use of Truvada as PrEP.It's good to hear that some doctors are standing up for their patients. Others appear to be in the thrall, or in the pocket, of Big Pharma. Many AIDS and human rights activists seem to have got the wrong end of the stick on this one: people have a right to safe healthcare, not to be used as free lab-rat material.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, 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..
Sunday, 4 March 2012
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..
Monday, 27 February 2012
Hiv Prevention-News Report-HIV
This news report details concerns over an HIV prevention pill.Tell drug maker Gilead and the FDA: There is No Magic HIV Prevention Pill!Send your eletters TODAY. Go to:www.nomagicpills.org.Your efforts are making a difference. Please re-blog. read more..
Sunday, 26 February 2012
Pharmaceutical Giant-Clinical Trials-Fda Approval-FDA
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FDA: Safety Before Profits!Pharmaceutical giant - Gilead’s application to expand use of its AIDS drug Truvada for use as HIV prevention pill in uninfected individuals alarms AIDS advocates who note FDA approval is unwarranted based on unsuccessful clinical trials. Join the advocates & send a message to the FDA! read more..
Thursday, 23 February 2012
World Health Organization-Treatment Of Hiv-Hiv Prevention-HIV Infections-Effectiveness
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Pre-exposure prophylaxis (PrEP) is an experimental method of HIV prevention. It involves a doctor prescribing antiretroviral HIV/AIDS drugs to a healthy person in order to prevent that person from possibly getting infected with HIV. So far, clinical trials have failed to prove PrEP’s effectiveness… (Click below to read more.)The 2007 iPrEX study found that PrEP reduced the risk of HIV infection among men who have sex with men (MSM) by only 44%. A part of the 2009 Vaginal and Oral Interventions to Control the Epidemic (VOICE) study was discontinued two years later because tenofovir (branded as Viread by Gilead Sciences) tablets were no better than a placebo in protecting HIV-negative women from HIV. Researchers stopped another trial in 2011, called Fem-PrEP, after they concluded that Truvada (Gilead’s combination tablet of tenofovir DF and emtricitabine) was unlikely to prevent HIV infection in women. Partners PrEP, a study of sero-discordant couples in Africa, showed an efficacy rate of 62%-73%. However it is imprudent to extrapolate the overall effectiveness of PrEP based of this study since the researchers reported an adherence rate of 95% among the study participants — a figure that would likely be much lower under non-clinical trial conditions and as a result, would likely lead to a lower overall efficacy rate.Questionable clinical efficacy aside, a surge in the interest around PrEP is puzzling given that 14.6 million HIV positive people around the world in need of ART right now are not receiving it. Expanding the permitted use of a lifesaving antiretroviral therapy—which is currently unavailable to those 14.6 million individuals still in need of treatment—as a sanctioned form of HIV prevention for use by uninfected individuals presents both a practical and moral dilemma for both Gilead and society at large.In the United States, the Centers for Disease Control and the Federal Drug Administration (FDA) have expressed interest in establishing guidelines for the use of PrEP. Under the current regulations, a medical provider is allowed to prescribe ART to a HIV negative person. This is called ‘off-label use’ – use of an HIV/AIDS medication for purposes other than treatment of HIV— effectively constitutes PrEP. However, as long as PrEP is not officially sanctioned by the FDA, drug companies cannot market ARTs as a preventative measure to the public. If PrEP is eventually approved by the FDA, pharmaceutical companies stand to make a lot of money catering to a new market in the developed world instead of providing cheaper—and much needed—drugs in the developing world.Internationally, PrEP has also received attention from the EU, the World Health Organization and various civil society organizations and advocates in the global health arena. The fact that PrEP is being considered as an evidence-based HIV prevention approach is incomprehensible at a time when the world cannot treat all people with HIV who are already ill.With the continued assault on generic drug manufacturers by Big Pharma and a stagnating commitment by the rich countries to contribute more money to the global AIDS fight, PrEP looks more like a pharmaceutical cash cow in the making, than a viable or prudent public health initiative. In the United States, one year of ART can cost upwards of $10,000 USD. Currently, there are waiting lists in the US for HIV-positive low-income people in need of treatment. In Eastern Europe, Central Asia and Africa ART coverage remains unacceptably low and far behind the Universal Access target of 80% for all who need it. Is it possible to justify giving PrEP to healthy people while the sick and dying are waiting for treatment?The legitimization of PrEP is detrimental because it could lead to a false sense of security among people who are currently using condoms to protect themselves. To achieve even a modest level of protection, PrEP requires strict adherence to a daily ART regime read more..