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HIV home tests come with a warning

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Medical colleges have expressed reservations about Federal Government moves to lift restrictions on manufacture and sale of home HIV test kits.

Health Minister Peter Dutton has opened the way for companies to seek approval to supply do-it-yourself HIV test kits in a move which, combined with steps to improve access to antiretroviral drugs, he hopes will assist in the early diagnosis and treatment of the disease.

Mr Dutton said many people were concerned about undergoing a HIV test in a medical setting, and the home self-testing added to the options for diagnosis.

The Minister said this was particularly important given the fact that “we know that there are Australians living with undiagnosed HIV”, and early diagnosis was critical to appropriate treatment and helping prevent the spread of the disease.

The initiative follows evidence that HIV is making a comeback in Australia.

The number of HIV infections jumped 10 per cent in 2012 to the highest level in 20 years, and has remained there since, according to data collected by the University of New South Wales’ Kirby Institute.

In its annual surveillance report released last week, the Institute said there were 1235 new cases of the virus diagnosed and reported across Australia last year, virtually unchanged from the 1253 new infections recording in 2012, and 70 per cent higher than the number of new diagnoses detected in 1999.

Of additional concern, the Institute found that around one in every seven people with HIV did not realise they were infected, and almost a third are diagnosed late, delaying treatment to restore their damaged immune system.

“In some cases, people are living for several years without knowing they are HIV-positive,” the Institute’s Associate Professor David Wilson. “This is a double concern: for their own health and that they could be passing the virus on to others.”

The report has underlined concerns about complacency regarding the potentially deadly disease.

Researchers have identified a rise in the number of gay men having unprotected casual sex, particularly among those diagnosed with HIV and those younger than 25 years.

This is despite progress made elsewhere in the world.

A review of the global epidemic co-authored by Monash University research Professor Sharon Lewin and published in The Lancet found that the number of HIV cases worldwide peaked at 3.3 million new infections in 2002, and was down to 2.3 million in 2012, while AIDS-related deaths had dropped from a zenith of 2.3 million in 2005 to 1.6 million in 2012.

Professor Lewin said advances in treatment had not only helped people with HIV to live longer, but had dramatically reduced their infectiousness, making a huge contribution to the reduced spread of the disease.

In addition to allowing the manufacture and supply of home HIV test kits, Mr Dutton has announced to the Pharmaceutical Benefits Scheme, effective from 1 July next year, making it easier to obtain prescription antiretroviral medicine.

The Government has committed $16.2 million over four years to lift restrictions on the supply of antiretrovirals and enable the medicine to be dispensed at any pharmacy.

But health experts have expressed concern about the introduction of do-it-yourself HIV testing.

Royal Australian College of General Practitioners President, Adjunct Associate Professor Frank Jones, warned of the risks of testing positive to HIV at home without access to medical expertise and information.

Professor Jones said that because the dangers of missing a HIV diagnosis were high, home test kits were highly sensitive and had a false positive rate of between 1 and 2 per cent.

“In a low prevalence country like Australia, single rapid tests – such as these at home test kits – are more likely to show a false positive than a true positive,” he said. “There is enormous potential for unnecessary patient distress as a consequence of inaccurate results without adequate follow-up with a medical professional.”

He said point-of-care testing in general practices, sexual health clinics and other health services was the safest way to improve access to testing and reduce the risks of HIV transmission, a view shared to a point by the Royal College of Pathologists of Australasia.

The College said home and point-of-care rapid tests were not as accurate as laboratory tests, raising questions about their efficacy.

“People who receive a positive result on a HIV self-test will require a laboratory blood test in order to confirm the result,” College President Associate Professor Peter Stewart said. “Equally, if a HIV self-test reveals a negative result, this may not mean that the person is free from HIV, as the test is known to produce a concerning rate of false negatives.”

He advised people to “think carefully about relying completely in self-testing, especially for such a serious diagnosis as HIV infection”.

Adrian Rollins