3TC RATIONING OVER, SAY GLAXO

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3TC RATIONING OVER, SAY GLAXO

AIDS TREATMENT UPDATE, July 1995
Edward King


Glaxo-Wellcome, manufacturers of 3TC, have told European AIDS groups that any HIV-positive person who qualifies for its expanded access scheme for 3TC should be able to receive the drug within four weeks, writes Keith Alcorn.

Last month AIDS Treatment Update reported on growing concern throughout Europe over the rationing of the drug in the face of growing demand. Glaxo-Wellcome introduced a 'pacing programme' in March, which permitted 110 people in Europe to be admitted onto the expanded access scheme each week. Individuals who cannot benefit from approved anti-HIV drugs, either because they have ceased to be effective or because they cannot tolerate the treatments, can apply for 3TC. There are no restrictions on its use in combination with AZT. Recent trial results show that the combination of AZT and 3TC is more effective at reducing levels of virus in the blood and raising CD4 counts than any other anti-HIV regime studied so far.

At a meeting with Glaxo-Wellcome in May, European activists called on the company to make more drug available to the expanded access scheme to ensure that no-one without other anti-retroviral options would lose out. Six weeks later, Glaxo-Wellcome has told activists that after a review of the open label programme and existing stocks of the drug, they are now confident that anyone who qualifies for the expanded access programme will get the drug within four weeks.

Glaxo-Wellcome is still expecting the drug to be granted accelerated approval in the US by early 1996, and is seeking a similar licence throughout the European Union for 3TC to be used in combination with AZT in people with CD4 counts under 500. A licence could be granted during the first half of 1996 if European drug approval agencies are prepared to approve the use of 3TC in combination with AZT even though there's no data on its effects on symptoms or survival.

If you are experiencing difficulties in getting 3TC and you qualify for the expanded access programme, the European AIDS Treatment Group would like to know. If you live in the UK, contact Patrick Lyster-Todd, Health Promotion Officer for People with HIV at the Terrence Higgins Trust, on 0171-831 0330.


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