AIDS TREATMENT UPDATE, Issue 38, February 1996
Edward King

The US Food and Drug Administration has formally approved the anti-HIV drug stavudine (also known as d4T, or by the trade-name Zerit) as a treatment for people who have already undergone prolonged treatment with AZT. The decision follows the recommendation of the FDA's Anti-viral Drugs Advisory Committee last December, as reported in AIDS Treatment Update issue 36.

In the UK, stavudine is not licensed, but is available to doctors through an expanded access scheme run by its manufacturer Bristol-Myers Squibb.

Although trials to date have tested stavudine as a single-drug regimen, it may be most effective as part of combination therapy regimens. Pilot studies have said to have produced promising results with the combination of stavudine with ddI, or with the Agouron protease inhibitor AG1343 (now known as nelfinavir, or by the trade-name Viracept).

* 3TC & pancreatitis

At the FDA committee meeting in Washington last December there were alarming reports that 3TC caused pancreatitis in up to 15% of children. This side-effect has not been seen in significant numbers of adults taking 3TC.

Now Glaxo-Wellcome has released information suggesting that the pancreatitis may have had other causes. Amongst these were advanced disease (the children's average CD4 count was only 19), use of medications such as intravenous pentamidine or ddI, use of intravenous feeding, and infections such as Cryptosporidium.

Further reassurance comes from an ongoing trial in which 200 healthier HIV-positive children are receiving 3TC but there have been no reports of pancreatitis to date.

* Major conference

The Third National Conference on Retroviruses and Opportunistic Infections takes place in Washington at the end of January.

Among important new pieces of AIDS research expected to be presented are: - evidence that combination therapy regimens containing ritonavir prolong survival in people with CD4 counts below 50 - results from new MAI prophylaxis trials - strong anti-HIV effects from the combination of indinavir, AZT and 3TC - more data from Delta and ACTG 175 - promising results from a pilot study of the combination of ddI and stavudine - evidence that changes in viral load after eight weeks of anti-HIV treatment can predict the long-term risk of developing new symptoms or dying.

The next issue of AIDS Treatment Update will feature a full report from the conference.

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