AIDS TREATMENT UPDATE, Issue 30, June 1995
Edward King

Worldwide demand for 3TC has rocketed since the release of trial results in Glasgow last November and in Washington last January. These results showed that the combination of AZT plus 3TC resulted in larger increases in recipients' CD4 counts and decreases in the levels of HIV in their blood than other treatment regimes studied to date. Trials to test whether the combination also delays symptoms and/or prolongs life are still underway.

In the meantime, Glaxo Wellcome has been running an expanded access scheme to provide 3TC to people who are ineligible for the trial and who can no longer benefit from the licensed anti-HIV drugs AZT, ddI or ddC because of side-effects or disease progression. But in March the company announced that it would have to restrict the numbers of people joining the expanded access scheme to ensure that there was enough drug to supply those currently on the scheme as well as the ongoing clinical trials. At present, only 460 new people worldwide are being admitted to the scheme each week, of whom 350 are in the USA.

The Glaxo Wellcome manufacturing plant for 3TC is being closed down in July for upgrading so that it will be able to meet the large demand for 3TC that is anticipated once the drug is licensed for prescription in the USA and Europe. The company plans to apply for 3TC to be licensed for use in combination with AZT as the initial anti-HIV therapy for people with CD4 counts below 500, although this may not be agreed by the regulatory authorities. A decision is expected from the US authorities in November at the earliest, and several months later in Europe.

Activists around the world have been negotiating with the company to try to ensure that any restrictions in the availability of 3TC ensure that people with HIV who are most in need of a new treatment option are given priority. In mid-May European activists met with Glaxo Wellcome to put forward their proposals.

At the meeting the company revealed that between now and the end of 1995 it plans to produce 2.4 tonnes of 3TC that will be set to one side in order to meet demand after the drug is licensed. If there were delays in licensing, some of that stockpile would be re-allocated to the expanded access scheme, allowing more people to be recruited. Activists argued that it would be more ethical to re-allocate the 2.4 tonnes to the expanded access scheme now, so that people without other treatment options are not prevented from obtaining 3TC.

This might mean that the company would not have a sufficient stock of 3TC to be able to supply the market when 3TC is licensed (particularly if that comes as early as November in the USA). The activist response was that Glaxo Wellcome should then delay launching 3TC on the market if this was necessary to build up stocks from the upgraded manufacturing plant. Although this might mean a delay in the availability of 3TC to the broader spectrum of people with HIV, activists argued that this was the best compromise to ensure that in the short-term the drug was made available to those with the greatest short-term needs.

Glaxo Wellcome is considering its response to the European proposal. A further meeting is planned in early June. In the meantime, for more information about obtaining 3TC see AIDS Treatment Update issue 27.

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