Raltegravir Launched in UK
New HIV drug becomes available for UK patients
28th January 2008 12:40
PinkNews.co.uk staff writer
A MIRACLE new pill that could give hope to thousands of HIV sufferers was launched in Britain yesterday.
The drug - called Raltegravir - drives down levels of the virus in blood.
And scientists say it could stop patients developing full-blown Aids.
Dr Mark Nelson, director of HIV services at London's Chelsea and Westminster Hospital, said the drug - which costs 647 for a month's course - would be a lifeline for thousands of patients who don't respond to existing treatments.
Studies showed 75 per cent of patients receiving the pill twice a day reduced the HIV viral load in their blood - compared with 40 per cent taking a dummy drug.
It is available in tablet form and has been approved for use in combination with other antiretroviral drugs to treat HIV infection in adult patients whose current therapy is no longer controlling the virus.
The BBC reports that more than one in 10 UK patients with HIV has some level of resistance to at least one drug before they have even begun therapy.
It is estimated that 73,000 people in the UK are living with HIV.
One in three people do not know they are infected.
2,700 gay and bisexual men were newly diagnosed last year, the highest number ever.
Across the UK 1 in 20 gay and bisexual men are now living with HIV and estimates suggest this figure is as high as 1 in 10 in London.
If rates continue the National AIDS Trust says that by 2010 there will be 100,000 people living with HIV in the UK.
"If someone becomes resistant to any of their drugs, their treatment needs to be changed, and drugs which work in innovative ways can make a real difference."
Two recent studies on Raltegravir examined its tolerability and efficacy, its ability to reduce viral load and raise CD4 cell count in treatment-experienced, triple class resistant patients living with HIV, a difficult to treat patient population.
24 week outcomes of the pooled studies have shown that 75 percent of patients receiving Raltegravir plus Optimised Background Therapy (OBT - a regime of active antiretroviral drugs tailored to individual patients, chosen by their physicians as most likely to be of benefit) achieved HIV viral load reduction to less than 400 copies/ml at 24 weeks compared to 40 percent taking placebo plus OBT.
In the same studies, it was shown that 63 percent of patients receiving Raltegravir plus OBT achieved HIV viral load reduction to less than 50 copies/ml at 24 weeks compared to 34 percent taking placebo plus OBT.
The studies also found the increases in CD4 cell counts from baseline were 84 cells/mm3 for patients receiving Raltegravir compared with 37 cells/mm3 for those receiving placebo.
An analysis of the same trials at 16 weeks showed that after 16 weeks of treatment, 'Isentress' plus OBT was generally well-tolerated.
The most commonly reported therapy-related side effects, as reported in at least three per cent of patients, were diarrhoea, nausea, abdominal distension, abdominal pain, flatulence, headache and fatigue.
HIV patients get new drug in battle to keep Aids at bay
A new class of drug for people with HIV is being introduced in Britain today, having been described by researchers as a huge step forward in treating the deadly infection.
Raltegravir, available as tablets to be taken twice a day, is approved for use with other antiretroviral drugs to treat HIV in about one in ten patients whose therapy has stopped working. Because of their potential to prolong life by decades, HIV drugs are considered cost-effective and raltegravir is likely to be available on the NHS for all infected patients.
Doctors believe that the drug could become standard treatment, potentially preventing HIV progressing into full-blown Aids. Three quarters of trial patients showed a significant reduction in viral load - the prevalance of the virus in their bloodstream - compared with 40 per cent taking current medication alone. Some patients had a marked improvement to the point where levels of the virus were "undetectable", doctors said.
An estimated 73,000 people in Britain are infected with HIV, or human immunodeficiency virus, which culminates in Aids (acquired immunodeficiency syndrome). Although HIV infection is still considered serious, early diagnosis and appropriate treatment can allow for a relatively normal lifespan.
HIV continually changes and can become resistant to treatment, leading to a continuing search for new drugs. Raltegravir is the first in a new class of HIV treatments called integrase inhibitors, which it is hoped will avoid the risks of heart attack and cancer associated with existing medication. It works by blocking integrase, an enzyme that HIV relies on to replicate itself. It affects the ability of the virus to infect other cells, thus reducing the blood's viral load.
During the trials, patients were given raltegravir or the dummy drug plus optimised background therapy (OBT), a regime of antiretroviral drugs tailored to individual patients.
One study published in The Lancet in April last year was based on 178 patients with advanced HIV. They had been taking regular antiretroviral drugs for about ten years but were not responding to them. Patients taking raltegravir had an average of a 98 per cent drop in their HIV ribonucleic acid (RNA) count, compared with 45 per cent in the dummy group. The number of CD4 cells, an indicator of the immune system's ability to fight disease, was also boosted.
Made by the US-based company Merck, the drug is also known by the brand name Isentress. Mark Nelson, director of HIV services at the Chelsea and Westminster Hospital, London, said that it had already provided a life-line to 30 of his patients. "While this is not a 'cure' for HIV it does mean we can suppress the virus to where it is virtually undetectable."
Dr Nelson added that the drug's long-term safety record would be very important, given that more adverse effects from existing treatments were emerging after many years of therapy.
"Raltegravir is going to be popular because it's very effective and it seems to have a good safety profile," he said. "Previous drugs have done a terrific job keeping people alive. But now we have to start thinking about safety."
Eight years and four different drug cocktails after Philippe B, 41, learnt that he had HIV, he almost gave up.
"Ten years ago nobody told you anything about the drugs or how to take them, so I stopped for a few months. I became resistant and had to change my combination. Every new combination meant new side effects - nausea, diarrhoea. Sometimes the fatigue was so bad, I couldn't get out of bed."
Philippe, who works for the Terence Higgins Trust, had a viral load of 500,000 (more than 100,000 is considered high) and was in hospital with toxoplasmosis, ulcers and paralysis. After three months, he started a new regime that was the first to work - his viral load is below 50.
Philippe says that he is lucky because he has yet to run out of drug options. "It's very important that there are new drugs. HIV is not a death sentence any more but there's still no cure. After you become resistant, you start running out of options."
33.2 million people infected with HIV worldwide
73 thousand HIV sufferers in Britain
32.1 average life expectancy of an HIV sufferer in the developed world after diagnosis
Sources: UNAIDS; Times database