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Monday 08 November 2010

Two more much-needed HIV drugs now funded

Posted in: New Zealand Daily News, HIV
By Daily News staff - 4th November 2010

After intense and ongoing pressure from physicians and HIV support organisations the government's drug buying agency has finally agreed to fund access to two much-needed new HIV drugs.

Pharmac has begun funding Etravirine and Darunavir from November 1. The two drugs are considered effective in suppressing HIV for people who have run out of other treatment options.

Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that works for patients infected with an HIV strain that is resistant to the other NNRTIs.  It's the first new NNRTI to be introduced in over 10 years.

Darunavir is a new protease inhibitor with a high genetic barrier to resistance, meaning a number of mutations in the virus are needed before resistance to this drug can develop.

Last year the New Zealand AIDS Foundation, Body Positive and Dr Mark Thomas, one of New Zealand's most senior specialists in HIV treatment, harshly criticised delays in the funding of both Darunavir and anti-retroviral Raltegravir as "putting lives at risk". Raltegravir was subsequently paid for from October 2009.

The NZAF is welcoming the long-awaited decision on Darunavir, in particular the news that the 400m mg tablet will also be available for treatment-naïve patients, and not limited to people who’ve already tried a range of treatments.

The Foundation's Director Positive Health Eamonn Smythe says: "While welcoming the relative speed of funding Etravirine, one year from application to approval, we are surprised that the funding of Darunavir has taken three years.

"This is of some concern to us as the Pharmacology and Therapeutics Advisory Committee (PTAC) recommended funding Darunavir at the same time as Raltaglavir, which was approved in October 2009. Funding both drugs at the same time was recommended because using Darunavir and Raltegravir as a combination has proven to be very effective.

"That is of some concern to us as medications that are needed and recommended by experts, should not be delayed until pharmaceutical companies have the ability to bundle them with other health products to get better pricing packages for Pharmac, but should be based on patients’ need and ensuring the best health outcomes for people needing medication," he says.

Senior infectious diseases specialist at Auckland Public Hospital Dr Mark Thomas says NNRTIs have been trusted by physicians and used in antiretroviral therapy for more than a decade, but the evolution of NNRTI-resistance has increasingly limited the use of this important class of HIV medications for some patients.

He says Etravirine extends the NNRTI class to patients who have NNRTI-resistant virus, with the potential to suppress their virus to undetectable levels, a major treatment goal.

"Pharmac's funding approval offers new options for people with HIV infection.  In two randomised trials involving nearly 1,300 patients, patients taking Prezista (Darunavir) were less likely to experience virological failure and have their HIV virus multiply despite treatment than patients taking another protease inhibitor," says Thomas.

Bruce Kilmister, General Manager of Body Positive in Auckland says it's good news for New Zealanders who are suffering debilitating toxicities from their older treatment regimens. He says treatment combinations including these drugs are generally well tolerated resulting in improved health and durable suppression of HIV.

Kilmister is thanking drug company Janssen New Zealand for making the medicines available free to New Zealand patients who needed them for over two years while the Pharmac funding application was in process.

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