Johnson and Johnson has “new option” HIV drug fast tracked

Johnson and Johnson has revealed that Prezista, an anti-HIV drug, has been given accelerated approval by the FDA as a new option for HIV-sufferers who have developed resistance to other anti-viral drugs and other protease inhibitors.

Accelerated approval – a means of getting earlier approval for drugs that demonstrably exhibit an advantage for people with serious or life-threatening illnesses – was given to Prezista following the successful results of a 24-week trial.

Some 45 per cent of Prezista patients achieved an undetectable viral load level, compared to 12.1 per cent compared to the placebo, while 69.5 achieved a response using the drug by the terms of the study’s design, in comparison to 21 per cent who used the placebo.

Dr Michael S Saag, director of the Aids Outpatient Clinic and the University of Alabama’s Birmingham Centre for Aids Research, remarked: “One of the greatest challenges in HIV care is finding therapies for treatment-experienced patients.”

“This is an important new option for the thousands of people with HIV in the United States who are resistant to more than one protease inhibitor,” he added.

Prezista is designed to be administered in combination with ritonavir and other antiretroviral drugs.

In 2003, the BBC reported that the vast majority of patients with HIV were surviving beyond ten years thanks to advances in antiretroviral therapies. In 2004, approximately 58,300 adults were living in the UK with HIV, of whom 19,700 were unaware of being infected, according to AVERT, a UK Aids/HIV charity. People aged 20-44 years-old account for 83 per cent of the Aids/HIV demographic, the charity says.

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