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U.K:HIV drug linked to liver disease News SX Wednesday 21 May 2008 Serious liver side effects have been reported in patients using HIV drug Prezista (darunavir), prompting the pharmaceutical company that makes it to issue a warning about the drug’s dangers. Tibotec, a division of Janssen-Ortho Inc, in cooperation with Health Canada, issued a statement on its website alerting the public to the fact that in clinical trials 0.5 per cent of patients experienced hepatitis while being treated with Prezista. In addition a further 13 reports of hepatitis have been reported since the drug went on the market between June 2006 and December 2007, including two patients who died. During the same period there have been 25 reports of patients who developed other liver problems including 14 who died. Patients who have liver problems, including hepatitis A or B, are at greater risk of developing serious adverse liver effects, Tibotec said. Prezista is used in combination with ritonavir, another antiretroviral medication, to treat HIV-positive people, for whom other antiretroviral therapy has failed. Prezista is available in Australia through the Pharmaceutical Benefits Scheme. Tibotec advised patients taking the drug who experienced dark urine, yellowing of the skin, abdominal pain (especially on the right side below the ribs), general itchiness, decreased appetite, nausea or vomiting and tiredness to seek the advice of their doctor. Meanwhile, the NSW government is calling on the federal government to support a trial in the state of the therapeutic use of cannabis-based drugs for people with cancer, multiple sclerosis and AIDS. The state government wants to trial Sativex, which delivers cannabis compounds through an oral spray and aims to counter the wasting effects of the diseases, as well as offer pain relief. The move was welcomed by Levinia Crook, CEO of the Australasian Society of HIV Medicine (ASHM), although she said it was more of an issue for HIV several years ago. “We’ve participated in this [sort of thing] a lot over the years,” she told SX. “Particularly from the point of view of a palliative care or cancer drug, many years ago it was much more of an issue for HIV than it is currently because you had people with extreme wasting and a much more cancer-like presentation of advanced disease.” ACON CEO Stevie Clayton also welcomed the news. “The problem in the past has been that the only effective way of administering the drug was through smoking which has its own negative effects, the legalities of supply could not be resolved and the Howard government consistently stood in the way,” she told SX. “This has delayed access to this treatment for many years. Hopefully most of those problems can now be resolved.” http://sxnews.e-p.net.au/news/hiv-drug-linked-to-liver-disease-3080.html
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