Monday, June 1, 2015

HIV treatment breakthrough: Reveals Antiretroviral drugs should be given at diagnosis NOT when condition worsens

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People with HIV should be given antiretroviral drugs as soon as they are diagnosed to lower their chances of Aids and other serious illnesses.

Experts have halted a major global trial 18 months early after 'clear-cut proof' that immediate treatment improves patients' chances.

They advise that rather than wait until a person's immune system is weakened by the virus, it is important to begin antiretroviral therapy straight away.

Scientists have hailed the findings groundbreaking, noting they mark the.....
first time a major clinical randomised trial has provided evidence in support of treating all HIV positive individuals, regardless of the progression of their infection.

For many patients, the drugs are only prescribed when their CD4+ cell count - a key measure of how strong the immune system is - falls below a certain level.
The fall indicates the body's immune system is weakened and is therefore more vulnerable to the effects of HIV.

In the UK, NHS guidelines dictate people who are HIV positive undergo regular blood tests to monitor the progress of the infection before embarking on treatment.

It involves monitoring the amount of virus in the blood - the viral load - and the effect HIV is having on the immune system.

This is determined by measuring CD4+ levels - the lymphocyte cells in the blood that are vital for fighting infections.

Treatment is usually recommended once CD4+ levels have fallen towards or below 350, regardless of whether a person is showing signs of HIV.

In the US, the Centers for Disease Control and Prevention already recommends starting treatment immediately after diagnosis.

But, in November health bosses revealed only 37 per cent of infected Americans had prescriptions for antiretroviral drugs, the New York Times reported.

The findings from the new study, funded by The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, support offering antiretroviral drugs to everyone diagnosed with HIV.

Past research supports the conclusion, showing the medication significantly reduces the risk of HIV transmission to uninfected sexual partners.

In general, people who are HIV positive have a low chance of passing the infection on to sexual partners, if they are being treated for the virus.

The Strategic Timing of AntiRetroviral Treatment (START) study marks the first large-scale randomised clinical trial to establish earlier therapy benefits all HIV-infected people.

Though the study was expected to conclude at the end of next year, an interim review of the data by an independent board recommended the results be released early.

Dr Anthony Fauci, director of the NIAID, said: 'We now have clear-cut proof that it is of significantly greater health benefit to an HIV-infected person to start antiretroviral therapy sooner rather than later.

'Moreover, early therapy conveys a double benefit, not only improving the health of individuals but at the same time, by lowering their viral load, reducing the risk they will transmit HIV to others.

'These findings have global implications for the treatment of HIV.'

Putting the findings into context, Dr Jens Lundgren, of the University of Copenhagen, and one of the co-chairs of the START study, said: 'This is an important milestone in HIV research.

'We now have strong evidence that early treatment is beneficial to the HIV-positive person.

'These results support treating everyone irrespective of CD4+ T-cell count.'

The START study, which opened in March 2011, was conducted at 215 sites in 35 countries.

It enrolled 4,685 HIV-infected men and women aged 18 or older, with an average age of 36.

Participants had never taken antiretroviral drugs, and were enrolled with CD4+ cell counts in the normal range - above 500 cells per cubic millimetre.
Approximately half of the study volunteers were randomised to start antiretroviral therapy immediately - considered early treatment.

The other half had their treatment deferred until their CD4+ cell count fell below 350 cells per cubic millimetre.

Scientists from the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) followed the participants for an average of three years.

They measured a number of different outcomes, including the number of cases of serious Aids-related illness, including Aids-related cancers
Serious non-Aids illnesses including cardiovascular, renal and liver disease and cancer, as well as death rates, were also noted.

The monitoring board, who reviewed the study's findings to date in March, found 41 cases of Aids, serious non-aids related illness or death among the group given early treatment.

That compared with 86 cases in the group where treatment was deferred.

The interim analysis found the risk of developing serious illness or dying was reduced by 53 per cent among those in the early treatment group, compared to those in the deferred group.

Rates of serious Aids-related illnesses and serious non-Aids-related illness were both lower in the early treatment group, than the deferred treatment group.

The findings were consistent across geographic regions, and the benefits of early treatment were similar for participants from low- and  middle-income countries, and those from high-income countries.

Professor James Neaton, from the University of Minnesota and INSIGHT principal investigator, said: 'The study was rigorous and the results are clear.

'The definitive findings from a randomised trial like START are likely to influence how care is delivered to millions of HIV-positive individuals around the world.' 

Prior to the START trial, there was no randomised controlled trial evidence to guide when to start treatment for those HIV patients who had higher CD4+ levels.

Previous evidence, which supported early treatment to those with CD4+ levels above 350, was limited to data from non-randomised trials, or observational cohort studies, as well as expert opinion.

START provides the first concrete evidence to support the US HIV treatment guidelines, which recommend all asymptomatic HIV-infected patients take antiretrovirals regardless of their CD4+ cell count level.

Current World Health Organisation HIV treatment guidelines recommend that HIV-infected individuals begin antiretroviral therapy when CD4+ cell counts fall to 500 cells/mm3 or less.

Dr Rosemary Gillespie, chief executive at the Terrence Higgins Trust, hailed the research as 'groundbreaking'.

She said it adds to a growing body of evidence that suggests 'there should be no delay in starting HIV treatment'.

'Early treatment and diagnosis mean that people living with HIV can expect to live long and healthy lives, and can also reduce the chances of HIV being passed on unwittingly.

'They are key tools in our efforts to stop the spread of HIV in the UK.'

Noting the disparity between the WHO guidelines and those set by the NHS, Dr Gillespie urged health bosses to take note of the START study's findings.

All of the study's participants have been informed of the results.

And those who are not already on antiretroviral treatment will be given the drugs, and will continue to be followed until the end of 2016, when the trial was initially expected to come to an end.

Culled - DM

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