HIV drug linked to serious liver side-effects, Health Canada warns

From the Canadian Press:
Health Canada and pharmaceutical company Janssen-Ortho are warning people taking the HIV drug Prezista that the drug can cause serious liver side-effects.

Prezista, which is used in combination with another antiretroviral medication known as ritonavir, is used to treat adult patients in whom other HIV therapy has failed.

The warning says that in clinical trials, 0.5 per cent of people who took the drug developed hepatitis or inflammation of the liver.

And since the drug has been brought to market, there have been 13 reports of patients who developed hepatitis, including two who died.

The warnings says that between mid-2006 and the end of 2007 there were also 25 reports of patients who developed other liver problems; 14 of those patients died. ...more

Association of Prezista (darunavir) with hepatotoxicity

From Health Canada:
Tibotec, a division of Janssen-Ortho Inc. ("Tibotec"), in cooperation with Health Canada, would like to inform you of important new safety information regarding hepatotoxicity in association with the use of PREZISTA (darunavir). PREZISTA, co-administered with ritonavir (rtv) and other antiretroviral agents, is indicated for treatment of human immunodeficiency virus (HIV) infection in adult patients who have failed prior antiretroviral therapy.
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Province to cover new AIDS drug

From the Toronto Sun:
Brian Finch is thrilled the Ontario government is now reimbursing AIDS patients for a new drug that has kept his viral load of the disease undetectable for the first time in 10 years.

The Toronto man had run out of options for battling his HIV until Health Canada approved Prezista last year, a drug now listed on the Ontario Drug Benefit Formulary. ...more

Drugs produced dramatic change in HIV patient

I have been able to see the use of these two new Tibotec drugs in action. Both look to be quite promising. TMC125 is most notable in that it's a new non-nucleoside reverse transcriptase inhibitor (NNRTI). We haven't seen a new drug in this class in some time. Its resistance profile is quite good as well. Typically, if the HIV virus is resistant to one of the existing NNRTI's, the virus is resistant to all drugs in this class. TMC125 appears to be effective in these resistant patients.

One addtional bit of info not included in this article: TMC125 has been given the generic name of etravirine. I have not heard of a suggested brand name yet.

From the Vancouver Sun:
The human immunodeficiency virus could have killed Vancouver artist Tiko Kerr 20 years ago, just as it claimed so many other promising lives.

Instead, his successful battle to live is now propelling him on a whirlwind world tour, talking to drug researchers, doctors and scientists about his story of survival and the two controversial AIDS drugs that helped him beat the odds.

"I've really come to the conclusion that the worse you have to go through, the greater the reward," Kerr says of his dramatic change in fortune.

The tour began in December, when Kerr, just shy of the one-year anniversary of his initial treatment with TMC114 and TMC125 as part of a small clinical trial at St. Paul's Hospital, travelled to New Jersey where he was invited to speak at the corporate headquarters of pharmaceutical giant Johnson & Johnson, and its subsidiary, Tibotec, which developed the two drugs. ...more

New HIV Drug May Be More Effective

FYI: Prezista has also been approved for use in Canada.

From CBS News:
A new HIV drug called Prezista helps curb HIV in patients who don't respond to other HIV drugs, a new study shows.

Prezista belongs to a class of drugs called protease inhibitors, which block HIV (the virus that causes AIDS) from multiplying.

The FDA approved Prezista in June 2006 for use with a protease inhibitor called Norvir and other anti-HIV drugs in adults whose HIV infection hasn't responded to other treatments. ...more