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Published on 17 August 2009

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Intelence accepted for use by NHS Scotland

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Tibotec, a division of Janssen-Cilag Ltd, today announced the acceptance of Intelence (etravirine) by the Scottish Medicines Consortium for use within NHS Scotland.

Etravirine, in combination with a boosted protease inhibitor (PI) and other antiretroviral medicinal products, is indicated for the treatment of HIV-1 in treatment-experienced adults.

“This is excellent news,” said Dr Gordon Scott, Lead Clinician, Department of Genitourinary Medicine, NHS Lothian.

“Etravirine is a powerful drug with a low rate of side-effects that offers considerable hope to patients whose existing HIV treatment is failing.”

Also commenting on the approval, Roy Kilpatrick, Chief Executive of HIV Scotland, said: “This decision is welcome news. We have been working with the SMC to ensure that effective HIV treatments are made available, and are glad etravirine will now be an option for people living with HIV in Scotland.”

Etravirine is a next generation non-nucleoside reverse transcriptase inhibitor (NNRTI) and is the first new NNRTI to be introduced in approximately ten years. Etravirine is also the first NNRTI to show efficacy in patients with virus that is resistant to first-generation NNRTI’s , extending an effective class of treatment for adults who have failed other antiretroviral treatments.

The SMC approval is based on data from two randomised controlled trials showing that etravirine achieved an undetectable viral load in significantly more highly-treatment experienced patients than those in the placebo group (58.9 vs. 41.1 percent. Patients treated with etravirine also experienced a significantly greater mean increase in CD4 cell count from baseline compared to placebo (86 vs. 67 cells per microlitre).  When compared to placebo, the most common adverse event was rash (any type) (20 percent vs 10 percent. Most cases of rash were mild or moderate in severity and resolved with continued treatment.

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