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..
Tuesday, 5 June 2012
Food And Drug Administration-Aids Healthcare Foundation-Poor Efficacy-Truvada
Monday, 4 June 2012
Retraction: 127 Zimbabwean Women-Antiretroviral Drug-HIV
Following an article in ZimEye.org, I mistakenly wrote that one arm of the Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial, involving the antiretroviral drug Tenofovir, was stopped because 127 women taking the drug became infected with HIV. In fact, these women were taken out of the trial because of 'futility', the finding that it would not be possible to show that the treatment they were receiving was more effective than the placebo that another group was receiving.I apologise for reporting something so alarmist when the only source was an online article (which apparently also appeared in the Sunday Mail) that was released without any named author. I will take more care in commenting on such articles in the future. I have removed my blog post from the three sites where I placed it and will make the same efforts to publicize this retraction as I made with the original.There will be a press release confirming the above, which I will post as a comment to this report as soon as it is available.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, 19 March 2012
Antiretroviral Drugs-Clinical Trials-Hiv Epidemics-Perspective-HIV
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]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
Pharmaceutical Industry-African Countries-Hiv Infection-Avac-HIV
Pharmaceutical industry front group AVAC is blowing the usual trumpet for PrEP because some recent trial results have been encouraging. They said predictably little about results which were not so encouraging.The problem with PrEP still remains: no high prevalence country has managed to put all HIV positive people on antiretrovirals, not even all those who are at the stage of disease progression where it is a serious threat to their health. Why does anyone think they can roll out a drug for people who are not infected with HIV on the grounds that it might give them 'up to' 73% protection?If 20% of sexually active people are infected with HIV and most of the other 80% are considered to be at risk of infection, will they all be given PrEP? Think of the cost, the logistics, the high levels of resistance, the side effects, things instititutions like AVAC and UNAIDS don't seem to be willing to discuss sensibly.It also seems like a humiliating climbdown for UNAIDS and all the others who maintained that HIV is almost always spread through unsafe heterosexual sex in African countries (though hardly ever in non-African countries, however unintuitive that may sound). Are all 'risk reduction' strategies now to cease?Will we instead just give out drugs and ignore the things we appeared to deplore for the last thirty years, promiscuous men, survival sex, commercial sex work, exploitation, early and unplanned pregnancies, early marriage, concurrent relationships, large numbers of partners, low use of condoms, lack of family planning and whatever other issues we have spent so long bemoaning?Warren Mitchell from AVAC remembered to thank the trial volunteers, presumably mostly guinea pigs who, if they are African, will never be able to afford the drugs and for whom the money to pay for them may never be raised. I don't suppose he was being ironic, either.Another move which looks suspiciously like a way to vastly increase the volume of ARV drug sales, and thereby increase dependency on drugs and funding, is a strategy called test and treat (or various other names). This involves testing the whole population of a country regularly, perhaps every year, and putting everyone found positive on treatment.Testing even a reasonable percentage of people in a population once has remained elusive, let alone the whole population or the whole population every year. But even testing once a year is not thought to be enough, so test and treat is still just a theory. And it is well known that early treatment carries a lot of risks that have not yet been adequately explored.It is to be wondered if people will be obliged to take the drugs by law or if they will face stigma if they refuse. UNAIDS has many years of experience in the use of stigma as a weapon with which to threaten people and punish them for being African so perhaps they have some plans in this area. No disease has ever been beaten by drugs alone so it seems hard to believe that HIV will be the first. But it is great news for the pharmaceutical industry.[For more about PrEP and HIV issues in Africa, see my other blog, HIV in Kenya.]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, 23 February 2012
Hiv Positive-Hiv Negative-Condoms-Arvs-HIV
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 tak read more..
Wednesday, 22 February 2012
HIV Infections-Hiv Prevention-Hiv Prevalence-Hiv Infection
Why do so manyHIV-positive children in Africa have HIV-negative mothers?Forexample, approximately 30% of HIV-positive kids aged 0-11 years haveHIV-negative mothers in Mozambique (see pp. 177-181 in:http://www.measuredhs.com/pubs/pdf/AIS8/AIS8.pdf).Why are so manyvirgin men and women found with HIV? In the Republic of Congo,for example, virgin women aged 15-49 years have higher HIV prevalencethan all women, 4.2% vs 4.1% (see p. 101 in:http://www.measuredhs.com/pubs/pdf/AIS7/AIS7.pdf).The personal storiesbehind these statistics are hard to fit with the common view thatalmost all infections are from sex. Why has there been so littleattention and response to Africans with unexplained infections?THE PURPOSE OFTHIS NOTE IS TO INITIATE DEBATE ABOUT WHETHER TO CONTINUE TO IGNORENON-SEXUAL HIV Infections IN AFRICA. To do so, this note presentsfour arguments for AIDS activists, both in Africa and elsewhere, torecognize and respond to HIV from skin-piercing procedures in Africanhealth care and cosmetic services.1.DE-STIGMATIZING HIV/AIDS: Programsfor HIV prevention in Africa – including especially foreign-fundedprograms -- focus almost exclusively on sex. With all attention onsex, the emotions, prejudices, and controversies around sex naturallyspill over into HIV programs. Thus, it is not only wrong to thinkthat all African HIV comes from sex (see points 3 and 4, below), butalso confusing and distracting. Currently, stigma against HIV is sogreat that most people with unexplained infections keep silent, so asnot to be accused of sexual behaviors that some people don’t like.When the public discourse is corrected to recognize blood-borne aswell as sexual HIV (see: http://dontgetstuck.wordpress.com),people with HIV from blood risks will be able to speak out withoutfacing stigma compounded by charges they are lying. And they willthen be able to contribute to public efforts to make health care andcosmetic services safe. 2. PREVENTING HIVINFECTIONS: Ensuring that medical facilities are safe willnot only prevent HIV infection but also the transmission of otherblood borne pathogens. Across Africa, HIV prevalence is lower incountries where more people are aware of blood-borne risks for HIV;see: http://dontgetstuck.wordpress.com/africans-aware-of/3. SEX ALONECAN’T EXPLAIN AFRICA’s HIV EPIDEMICS: Allattempts to explain Africa’s epidemics as exclusively sexual havefailed to find anything that is so different about sex in Africa thatcould account for Africa’s high rates of HIV prevalence.Studies find that Africans have fewer partners and use condoms morethan Americans and Europeans. Circumcision is lesscommon in Europethan Africa. Sex can’t explain how HIV prevalence is lower afterlong term wars, and among people living further from health clinics.Sex is a risk for HIV because so many Africans are infected – buthow are so many infected? 4. EVIDENCE THATAFRICANS GET HIV FROM SKIN-PIERCING EVENTS: Alot of evidence shows HIV transmission through skin-piercingprocedures in Africa.Evidence is both old and new. For example:(a) In 1985, ProjectSIDA in Kinshasa,Zaire(now the Democratic Republic of Congo), tested inpatient andoutpatient children aged 1-24 months and their mothers for HIV.Seventeen (39%) of 44 HIV-positive children had HIV-negative mothers.Among children with HIV-negative mothers, “medical injectionsseemed to be the most important risk factor for HIV…” The studyteam noted, “Injections are often administered in dispensarieswhich reuse needles and syringes yet may not adequatelysterilize them” (Mannet al, Riskfactors for human immunodeficiency virus seropositivity amongchildren 1-24 months old in Kinshasa, Zaire. Lancet1986, ii: 654-7. p. 656.)(b) Around 1990,WHO’s Global Programme on AIDS coordinated a study in Rwanda,Uganda,Tanzania,and Zambiato test in-patient children 6-59 months old and their mothers forHIV. Sixty-one (1.1%) of 5, read more..