[In Australia, their] National Association of People Living with HIV/AIDS (NAPWA) has issued an urgent alert for people taking the antiretroviral drug Darunavir, brand name Prezista, and formerly known as TMC-114.

The drug has been linked to serious liver side effects after a series of problems arose for patients in Canada.

Canadian health officials registered a concern over the drug after a number of cases of patients developing liver complications were reported, which in a few cases led to death.

During clinical trials for the drug, 0.5 percent of patients developed hepatitis or inflammation of the liver. However, since Darunavir’s approval in North America there have been 13 reported cases of patients developing hepatitis and two deaths. A further 25 cases and 14 deaths have been reported as a result of other liver problems which developed in patients taking Darunavir.

NAPWA treatments spokesman Bill Whittaker stressed it was still not known whether the liver complications were caused by Darunavir or if they had been caused by other medical complications and medications being taken by the affected patients. NAPWA is yet to consult with the drug company Janssen-Cilag, who distribute the drug in Australia.

For now, patients who are taking the drug have been warned to be on the lookout for signs of liver toxicity which include dark urine, yellowing of the skin, abdominal pain on the right hand side, itchiness, decreased appetite, vomiting and fatigue. [Supplementary note: In New Zealand, Pharmac prescriber notes refer to liver toxicity and existing problems as a contra-indication. However, that information may have been based on the earlier PTAC assessment in November 2007. Ani Lamont’s piece doesn’t refer to when the Canadian clinical test showed the aforementioned adverse reactions to duronavir, but I’ve since accessed Health Canada’s website. They issued an advisory dated 15 May, with a link available below. The information has been sent on to NZAF).

Whittaker advised patients taking Darunavir to continue taking the drug unless advised by their doctor not to, but to seek medical treatment should they show any signs of liver complications.

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Supplementary Note: Darunavir/Prezista has been assessed by Pharmac’s PTAC as of November 2007. However, at present I am currently unsure whether it is available for general distribution to PLWAs who have developed resistance to other protease inhibitors and combination therapies. I’ve passed on the information above to NZAF, and I am told that their Positive Health manager will be responding to it in due course.

Strongly Recommended:

Ani Lamont: “HIV/AIDS Drug Warning” Sydney Star Observer: http://www.ssonet.com.au

Pharmac PTAC Notes:

http://www.pharmac.govt.nz/2008/03/06/070308.pdf/text

MedSafe Prezista/Duronavir Prescriber Information:

http://www.medsafe.govt.nz/consumers/cmi/p/prezista

Health Canada: Advisories, Warnings and Information for
Health Professionals: Duronavir/Prezista (15.05.08):

http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2008/prezista_hpc-cps_e.html