AIDS Treatment Update, Issue 40, April 1996
Keith Alcorn

A small number of people at three UK clinics are already receiving Merck's indinavir (also known as Crixivan) through an expanded access scheme, which is now fully enrolled. Merck says indinavir will be available for any person with HIV on a named patient basis from May. This means that your doctor must contact the company's Medical Information Department on 01992 467272 and give details of your case.

* Ritonavir

Abbott also plans to make ritonavir (Norvir) available on a named patient basis, but no timetable has yet been announced. For further information clinicians may contact Dr Christina Carnegie, Medical Director at Abbott Laboratories on 01628 773355.

* Saquinavir

An expanded access scheme to provide clinics with free supplies of saquinavir (Invirase) for people with 'no further treatment options' (essentially, those no longer benefiting from the existing range of available treatments) has finally begun.

The scheme offers a dose of 1800 mg per day. However, research has suggested that the poor absorption of saquinavir in the gut means that too little drug enters the body. Preliminary research suggests that drug absorption may be even worse in people who have diarrhoea. This poor absorption may explain why saquinavir has yet not demonstrated the dramatic anti-HIV effects seen with ritonavir and indinavir. One study found that doses of 3600 mg or higher resulted in much more profound and prolonged suppression of HIV.

It has been suggested that people who want to benefit from saquinavir could register for the expanded access scheme under different names at several different clinics, in order to get a higher daily dose. European activists have urged manufacturers Roche to make a higher dose available though the expanded access programme, but Roche's saquinavir research director Dr Keith Bragman says it would be irresponsible for the company to do so without further study, given that only forty individuals have taken high-dose saquinavir to date.

* Nelfinavir

Nelfinavir (AG1343 or Viracept) will be available through the AVANTI 3 study, in which participants receive either AZT plus 3TC, or the triple combination of AZT, 3TC and nelfinavir. The trial is confined to individuals with CD4 counts between 150 and 500 who have not taken any anti-HIV drugs before, and will recruit patients at the Kobler Centre and the Royal Free Hospital.

Agouron plans to establish expanded access arrangements as soon as possible, but is still trying to scale up production of its drug to meet the anticipated demand when it is licensed in the US, which will probably happen before the end of 1996.

* KNI-272

KNI-272, or kynostatin, is an experimental protease inhibitor made by Japan Energy which is now in early human trials. It is available only through a study at the Kobler Centre and St Mary's Hospital in London, which is designed to find the best dose of the drug. Those who tolerate the drug and who experience a 90% or greater fall in viral load may be allowed to continue on the drug after the three month study ends. Some activists are concerned about this study because it requires participants to take a gradually increasing dose of the drug, and with some other protease inhibitors starting on too low a dose led to the rapid emergence of resistance. If an individual is resistant to KNI-272, they may be cross-resistant to ritonavir.

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