POST EXPOSURE PROPHYLAXIS
WHO DISCUSS RAPE/HIV & ANTIRETROVIRALS

A special committee of the World Health Organisation will meet this week to discuss issues around rape, HIV and antiretrovirals in South Africa, while the US Centres for Disease Control are rescrutinising their guidelines for rape and HIV.

In addition the State of California has issued guidelines for post-exposure prophylaxis (PEP) after rape following a year-long study that showed that antiretrovirals taken after rape prevent HIV transmission. In addition, a new study from Denmark shows that PEP taken timeously after a blood transfusion of HIV-infected blood into an HIV-negative person can prevent HIV transmission.

A large body of research emanating from France, South Africa, the USA and Denmark is proving that PEP, taken within 72 hours, after rape, a needlestick injury, high risk sex, or a blood transfusion reduces by 100% HIV tranmission.

But while science is working hard on proving this link, the most shameful silence within the South African debate has come from Glaxo-Wellcome, the makers of AZT, who have not alerted the South African public to this research amid a plethora of contradictory, and inaccurate government statements. Glaxo are making a fortune selling AZT to rape survivors here and in the rest of the world, but instead of issuing a clear statement and putting lives before business and politics they choose to be unclear, silent or evasive.

The media has also been less than exemplary in pursuing research to establish truth. A week ago The Star published an article saying that AZT after rape was not effective and no studies had been done to test that theory, when two senior editors were alerted to the inaccuracy, they too failed to correct it. And yet there is a wealth of information to prove that antiretrovirals are not only effective but in populations with a high level of HIV infection, the use of antiretrovirals after rape in adults and children is essential. There are 15 different antiretrovirals on the market of which AZT is only one. New research from Denmark published in the American Journal of Physicians from scientists at the National University Hospital Rigshospitalet and State Serum Institute in Copenhagen, shows that antiretroviral treatment taken by a 13-year-old child, 50 hours after receiving a blood transfusion of HIV infected blood from a donor with fullblown AIDS, saw the child test negative for HIV for more than a year after the transfusion. The child is still clear of infection. Given this research and that from the USA, most particularly, California, New York and France which showed HIV cannot be transmitted after rape if antiretrovirals can be given the CDC has embarked on writing new guidelines for PEP after rape. They are not expected out before early next year.

The CDC September, 1998 guidelines, which, in passing, referred to HIV risks after sexual assault based on needlestick injuries, saw a lengthy exchange of letters between President Thabo Mbeki and Tony Leon. Mbeki maintained that it was highly unlikely that HIV could be transmitted during rape, and if it was antiretrovirals would be ineffective. Research debunks this. The Centres for Disease Control in Atlanta, USA is considered the most authoritative AIDS research organisation in the world. The 1998 CDC research suggested that triple therapy (such as AZT, 3TC and Crixivan) taken soon after a rape would probably ensure that 81% of patients would not become HIV+.

A growing body of research shows that AZT or similar antiretrovirals are 100% effective after rape, and in the 28 days that a rape survivor takes those drugs s/he will experience minimal, if any, side effects. No rape survivor who was HIV negative on the day of the rape, and who takes antiretrovirals after rape develops HIV, even when it can be proven that his or her rapist or rapists were HIV+.

Research at Johannesburg's Sunninghill hospital with more than 100 rape survivors shows that not one seroconverted after using AZT and 3TC. A study delivered to the Durban AIDS conference in July by scientists, Jean-Pierre Benais and a team from France had identical results: of 100 rape survivors given anti-retrovirals from five Parisian clinics since June 1999, not one had sero-converted. "Two perpertrators were known as HIV positive and the others refused testing."

The new CDC guidelines will rely fairly significantly on new guidelines published this month by the State of California, based largely on their own experience in giving antiretrovirals to rape survivors since 1998. In a study by Dr Josh Bamberger in San Francisco, not one of 200 rape survivors sero-converted after being given antiretrovirals, better known as PEP or post-exposure prophylaxis.

The California guidelines, have in turn, been influenced by those from the New York State AIDS Institute for "HIV prophylaxis folowing sexual assault" which have been in place since 1997. The California guidelines note: "PEP medications taken soon after exposure to HIV can prevent HIV infection... The CDC's Hospital Infections Director has recommended that PEP be initiated within 72 hours for individuals with recent sexual exposure to HIV and the San Francisco's non-occupational PEP service uses 72 hours as its cut-off. In the sexual assault context, given the delay that commonly occurs between assault and medical treatment, the advisory panel recommends setting the cut-off for treatment initiation at the outermost acceptable limit."

It also notes aspects of rape that increase risk: "presence of blood; survivor or assailant with a sexual transmitted disease with inflammation such as gonorrhea, chlamydia, herpes, syphilis, bacterial vaginosis, trichomoniasis, etc.; significant trauma to survivor; ejaculation by assailant; multiple assailants or multiple penetrations by assailant(s)." In South Africa most rape is gang rape.

Mbeki in his letter to Leon relied on data on receptive vaginal intercourse. Rape is non-receptive, or as I noted in my presentation to the AIDS conference where I spoke on Post Exposure Prophylaxis: "when I was raped last year, I was dry which meant there was greater genital injury, which facilitates infection if the rapist is HIV+. In the instance of a woman gangraped in SA - which is true for 75% of women - more than one of her attackers may be HIV+, their viral loads will tend to be high, she may be infected with more than one strain of the virus, it is likely the assailants have sexually transmitted diseases and it is unlikely they are on treatment for HIV. The raped woman or child therefore may have multiple exposure to HIV." In addition, Post Traumatic Stress Syndrome, which all women experience after rape depresses the immune system and gives the virus free rein. Mbeki said there could be no research because doctors would not allow so-called blind trials - where half receive the drug and half recieve placebos or sugar-coated pills. But in fact, there were no such trials for needlestick injuries whcih medical staff rely on. A prominent foreign scientist noted: "There's never going to be a randomized clinical trial to address the issue of PEP in the non-occupational setting, not only because it's not feasible (just like it was not feasible in the occupational setting), or ethical. It never happened in the hospitals, and will not happen in rape and child abuse crisis settings."

In occupational exposure - mostly doctors or nurses who get so-called needlestick injuries, where blood from an infected patient is splashed into their eye or accidentally transmitted to them through a cut or injection, no such trials were carried out given fears about HIV transmission, even though the risk in these instances of potential transmission is far lower than in rape.

Why do antiretrovirals not say on package inserts that they can be used after rape? Few drugs carry all their uses on package inserts. The foreign scientist noted further: "The point that the standards for recommending off-label use of a drug (using a drug that is not necessarily recommended for that use by manufacturers) should not be higher just because the indication is less or more popular. Estimates (for risk) are surrounded by broad confidence intervals and for all exposures (needlestick, sexual) and are modified by factors (such as injection of blood intramuscularly, for needlesticks, bleeding or trauma, STDs, for sex) associated with the exposure.

The fairest representation of what the recommendations truly are, from all the organisations in the USA recommending PEP after rape is that off-label use is that there are generally no good reasons for manufacturers to add indications for their products. Guidelines in the past may have exaggerated the risks of zidovudine (AZT) and minimized the potential benefits of PEP and the risk to survivors, and not put into perspective the elevation of risk associated with force, bleeding and high prevalence of STDs."

Mbeki querying the use of PEP said, "you might care to consider what it is that distinguishes Africa from the United States, as a consequence of which millions in sub-Saharan Africa allegedly become HIV positive as a result of heterosexual intercourse, while, to all intents and purposes, there is a zero possibility of this happening in the US." Last week, the US House of Representatives also passed a bill compelling those accused of rape to be tested for HIV, if the person raped requests it.

In fact, PEP or antiretrovirals after high risk sexual exposure is prevalent right across the United States and is given free, not only to those raped, but to those who might have had a high risk sexual contact and panicked about their HIV risk in the morning. Dr Michelle Roland of the San Francisco Health Department says they sometimes give PEP to such people three or four times in a year.

I know two women who are presently in final stages of AIDS. They became HIV+ after being gangraped, both are mothers, both are unemployed, one is single, one is black, the other white. The one is 28kg and I am sure will not live to see the end of this year. Their illnesses and deaths could have been prevented. ends

from Charlene Smith
2/11/2000

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