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.

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

Wednesday, August 17, 2011

Can HIV Drugs Replace Human Rights?


Here's another interesting post about PrEP from Joseph Sonnabend's blog. In addition to the iPrEx trial showing a very small absolute risk reduction for Truvada, the cost of preventing one HIV infection is also massive. Sonnabend's estimate is about half a million dollars.

Even at a fraction of that cost, it seems unlikely that any high HIV prevalence country could afford PrEP. Nor are any donors likely to be in a hurry to finance a large PrEP program.

But there are a couple of other worries expressed: PrEP will only be appropriate for a small number of people, and they are mostly living in rich countries. And HIV prevention as a whole is in danger of being thrown off course by the euphoria about PrEP. Money which should be going to education could be diverted to drugs which are expensive and of very limited use.

People still need to be aware of the risks of being infected with HIV and of what they can do to avoid it. Spending all prevention funds on PrEP will not have the impact being claimed by the HIV drug industry.

Here in East Africa, there has been so much discussion about people's rights over the years, how those rights have been denied and how this relates to HIV transmission. Are their rights now so worthless that they can be replaced with some overpriced drugs that don't even work very well?

allvoices

Tuesday, August 9, 2011

Vital Distinction Between Absolute and Relative Risk Reduction

In order to understand how misleading all the jubilation about recent PrEP trials is, have a look at one of Joseph Sonnabend's two blogs. He explains the difference between relative risk reduction, which is the widely reported finding from the trials, and absolute risk reduction, which is the very low figure that doesn't seem to have been reported at all.

The first blog launches straight into explanations of the two risk figures and an account of why the difference matters so much. But either blog will demonstrate how the whole PrEP issue has been blown up into a 'game changer', in the words of the HIV industry.

Sonnabend shows that the absolute risk reduction is only 2.3%, a far cry from the 44% relative risk reduction reported, which doesn't really give you any way of evaluating the trial results. He also points out that 45 people need to be treated with Truvada to prevent one HIV infection.

There are over 40 million people in Tanzania and only a few hundred thousand of them currently receive antiretroviral drugs, out of well over one million HIV positive people. If PrEP just involved drugs it might be possible to work out the exorbitant amounts of money required, but drugs are only part of it.

It's time for a bit of honesty in reporting figures when it comes to drug trials. There are millions of HIV positive people and tens of millions of people who may be at risk. They deserve the truth.

allvoices

Tuesday, August 2, 2011

Why PrEP When Condoms and PEP Would do the Job Better?

I'm still a little puzzled as to why PrEP is considered to be such a great idea, except by the pharmaceutical industry, of course. PrEP is nowhere near effective enough for people to depend on it; they will need to use condoms as well. So why go to such effort and expense? The chances of a condom bursting are very small and if it happens, people can use post-exposure prophylaxis (PEP).

The difference in cost is obvious. PEP would also reduce the likelihood of resistance developing and remove the need for long term adherence. And the side-effects which the pharmaceutical industry don't like to allude to, especially the long term side-effects, will be irrelevant except for the duration of treatment.

[For more about HIV and risk, see my other blog, HIVinKenya]

allvoices

Monday, August 1, 2011

UNAIDS: Everyone in Africa is at Risk of HIV; so PrEP is Useless?

I've found an uncharacteristically sensible article on PrEP, although it's written from a US perspective. It concludes that "Findings from the randomized clinical trials that PrEP is efficacious should mark the beginning of the policy discussion, not its end."

The article also demands proof of desirability and even deliverability of PrEP before the strategy is implemented. The authors note that sustained and effective counseling is a must to ensure proper adherence to the drugs and that the level of counseling required, which makes up a major part of clinical trials, is unlikely to be part of a community implementation.

Also noted are the lengths that researchers had to go to in order to retain participants in the iPrEx trial, an aspect of such trials that is rarely mentioned when reports of standing ovations at expensive pharmaceutical sponsored conferences come out. The odds during the iPrEx trial seemed to have been stacked against getting a poor result. And yet the result was pretty unimpressive.

The article covers a lot of interesting aspects of PrEP that are rarely mentioned among the post trial hype, such as development of resistance to antiretroviral drugs, increased 'unsafe' sexual behavior among some who think PrEP will give them 100% protection and the sheer cost of such a program that provides drugs for uninfected people when there isn't even enough funding for those who are infected.

But the article, perhaps being written from a rich country perspective, doesn't mention how spectacularly unsuccessful we have been in identifying 'core transmitters' of HIV in developing countries. In fact, any group that could be considered to be contributing significantly to HIV epidemics in high prevalence African countries is dwarfed by the percentage of infections that are said to come from 'low risk' groups.

In short,if PrEP ever proved itself to be feasible in high prevalence African countries, we wouldn't have the faintest idea where to start.

[For more about HIV and risk, see my other blog, HIVinKenya]

allvoices

Wednesday, July 27, 2011

Wagging Fingers Hasn't Worked; Let's Try Pills

It is very reassuring that a commentator in Kenya has mentioned, albeit briefly, that providing ARVs to HIV negative people will strain resources in a country where it is not even possible to supply all HIV positve people with them.

Many people don't have food, water, cheap drugs for everyday, but deadly, diseases, contraception and family planning, proper education, infrastructure, and a great many other things. Why the obsession with grossly overpriced drugs that will not make any material differenc to most people's health?

But there are some odd remarks in the article. One person mentioned in the article that she had not had sex with her husband for the first three years after finding out that he was HIV positive. Then she started to use condoms.

So far so good. Condoms give a good level of protection if they are used properly and used all the time. There are all sorts of stories about condoms breaking but this should be rare if people really know how to use them properly. And at least condoms are cheap and have other benefits, protecting against sexually transmitted infections and preventing unplanned pregnancies.

But the article is about using drugs to reduce HIV transmission. This would be in the form of pre-exposure prophylaxis (PrEP), where a HIV negative person takes an antiretroviral drug regularly to reduce the probability of being infected, or 'treatment as prevention', where the HIV positive person takes ARVs which reduce the viral load to a level where HIV is a lot less likely to be transmitted.

If condoms are used, is the risk that the HIV negative partner faces going to be reduced further when they also take PrEP? Perhaps so, perhaps a belt and braces policy gives more protection.

But if the HIV positive partner is on ARVs, taking them correctly, responding to them (to the extent that their viral load is low, etc), does the HIV negative partner need to be taking PrEP? Couldn't the HIV negative partner just make sure that condoms are used?

The more important questions are about whether there will be enough money for all HIV positive people to receive the drugs and other care they need, as well as for HIV negative people to receive the most effective prevention assistance available.

Currently, only 20-40% of people in need of ARVs are receiving them. Will the need for PrEP be given priority over the need for ARVs, given that PrEP is for people who are healthy and normal ARV treatment is for people who are sick and will die without the drugs?

But even 'treatment as prevention' is not that straightforward. The majority of people in most African countries do not know their HIV status. Even the majority of HIV positive people do not know their status. How easy will it be to identify all HIV positive people and keep on identifying new infections for as long as they occur.

Apparently Swaziland is going to test its entire population and put everyone found to be HIV positive on ARVs, effectively, 'treatment as prevention' or 'test and treat'. There are only 1.2 million Swazis but an estimated 200,000 of them are HIV positive.

Yet only about 60,000 HIV positive Swazis are on ARVs and the country doesn't even have enough supplies for them. Similar shortages have occurred in other African countries. Health services can barely cope with keeping a fraction of people on treatment, let alone all those who need them.

The Kenyan article continues with the sort of honesty that you wouldn't normally find in an article about HIV: prevention so far has had little impact and the rate of new infections is still very high; sexual behavior change, the main aim of most prevention programs, has not occurred to any great extent.

But UNAIDS and the HIV orthodoxy have, according to the article, been targeting the wrong people all along. They have been talking about reducing numbers of partners, using condoms and even giving up sex altogether. But many new infections occur in mutually monogamous couples, often among people who take precautions and who don't take risks.

The biggest problem with both PrEP and 'treatment as prevention' is that we have been very poor at identifying where new infections are coming from, so we are still, many years and billions of dollars later, in a poor position to know how to traget these expensive interventions, if the money does miraculously appear.

HIV prevention programs are usually targeted at whole populations, many of whom are not at risk. But even those who are not 'at risk' by UNAIDS' criteria become infected with alarming frequency. The plan seems to be to put as many people as possible, HIV positive and HIV negative, on drugs because, rather than despite the fact that, we haven't a clue why most people are infected.

ARVs appear to have an effect, whether used for PrEP or 'treatment as prevention', but we don't really know who to give them to. So we are going to try and give them to as many people as possible, in the hope that it will work, apparently. Is this modern medicine? It's no wonder people are suspicious about 'public health' programs.

allvoices

Wednesday, July 20, 2011

ARV Resistance: the Ultimate Pharmaceutical Industry Wet Dream

Few in the pharmaceutical industry wish to discuss the important issue of resistance developing to antiretroviral drugs (ARV). Resistance inevitably develops but the question is, at what rate? In high prevalence countries, which are also resource poor countries, there are very few types of ARV available. So when resistance develops to the common ones, there are few alternatives left and most of them are prohibitively expensive.

Ed Susman discusses resistance, which seems to develop rapidly in the US. The US has one of the highest average spends on healthcare in the world. People on ARVs there are monitored carefully and their regime is changed relatively quickly when the patient is not responding for any reason. This is unlikely to happen in developing countries, where most detailed monitoring is beyond their reach, for a variety of reasons.

Another thing Susman discusses is transmitted resistance, which means that a person with a resistant strain of HIV can transmit their resistance, along with the virus. Therefore the current rate of resistance could rise sharply, especially where HIV transmission rates are high.

This might be an acute problem in countries where there is talk of rolling out PrEP on a large scale or using HIV treatment as a means of preventing HIV transmission. Huge numbers of people will be on ARVs with very little monitoring and probably fairly lax adherence. Given that it takes many months to discover non-response to drugs and provide a change of regime in some rich countries, this problem is going to be a lot more challenging in poor countries.

Susman does not discuss resistance in a context where some, perhaps a lot, of HIV is transmitted non-sexually. If large numbers of people are being treated in unsterile conditions and HIV happens to be transmitted nosocomially, the rate of resistance to common drugs, usually the only affordable ones, could increase and leave many patients beyond help.

As one of Susman's informants says "individuals infected with HIV who respond to antiretroviral regimens can anticipate a life expectancy that is similar to uninfected people, because of the number of treatment options currently available. However, in these young people who already have lost one or two or more classes of drugs, [there will be] limited options for therapy". The options will be a lot more limited in African countries, if there are any options.

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