AIDS TREATMENT UPDATE, Issue 43, July 1996
Edward King

Several of the newer anti-HIV drugs are likely to be fully licensed and available in hospital pharmacies by the end of the summer.

In recent months, the pan-European drug licensing agency, the EMEA, has given the go-ahead to 3TC, ritonavir, saquinavir and indinavir. The EMEA's recommendation still needs to be formally accepted by the European Commission, but this is a formality requiring between 90 and 120 days. By late July the EC is expected to have approved 3TC and ritonavir, followed by saquinavir and indinavir before the end of September.

The expanded access schemes which currently provide these drugs to people with HIV will be wound up once the drugs are available for prescription like any other licensed therapy.

* MAI prophylaxis

The US Food and Drug Administration has approved the antibiotic azithromycin for preventing MAI in people with CD4 counts below 100. It will be prescribed as a once-weekly 1200 mg dose, making it cheaper and more convenient than the other approved drug, rifabutin.

In the UK, only rifabutin is currently licensed for MAI prophylaxis, although not all clinics recommend it (see AIDS Treatment Update issue 37).

A study presented at the Washington AIDS conference last January compared the effectiveness of azithromycin (1200 mg weekly), rifabutin (300 mg daily) and the combination of both drugs. The combination was best at preventing the appearance of MAI organisms in the blood (bacteraemia), but even azithromycin on its own was significantly better than rifabutin. There was no difference between the treatments in terms of survival.

However, azithromycin or a closely related drug, clarithromycin, are both important components of the combination regimens used to treat people who do develop MAI. Some doctors are concerned that using either of these drugs for MAI prophylaxis may encourage the emergence of drug-resistant MAI strains that may then be hard to treat.

In the study described above, two of the 18 people (11%) who developed MAI bacteraemia despite taking azithromycin monotherapy were found to have azithromycin-resistant strains. MAI that has become resistant to azithromycin is nearly always cross-resistant to clarithromycin, and vice versa.

* KS laser trial

The Royal Free Hospital is recruiting for a study of a new experimental treatment for Kaposi's sarcoma called photodynamic therapy.

The treatment uses a drug called SnET2 that concentrates in tumour cells and other fast-reproducing cells, but on its won does them no harm. When it is exposed to a form of laser light (which on its own is entirely harmless), the drug destroys the cells. By giving the body 24 hours to clear the drug from all but fast-reproducing cells and then only exposing tumours to the laser, the drug can be used to destroy tumour cells without harming normal cells.

Participants will be highly sensitive to bright light for a week or two after the treatment, possibly longer. Bright light (including sunlight even on cloudy days) may cause skin reactions like sunburn, or irritate or damage the eyes.

You may be eligible if you have between 4 and 36 KS lesions on your skin and have not received any anti-KS treatments in the last month. For more details, contact Deborah Farmer at the Royal Free Hospital on 0171-794 0500 bleep 660.

* Viral load plans

The Inner London HIV Commissioners Group have announced that they will be working with London's main treatment centres to ensure that viral load testing can be funded if centres wish to provide the test for patients.

Speaking at the TAT Treatment Information Forum on viral load testing, Dr Alison Rodgers of Kensington Chelsea and Westminster Public Health said that St Mary's Hospital and the Chelsea and Westminster Hospital were currently developing a research programme which would look at the usefulness of viral load testing in clinical decision making. It is hoped, say commissioners, that this research will help hospitals throughout London in deciding when to offer viral load testing.

* New MRC trials

The Medical Research Council is currently planning two new trials of anti-HIV drugs.

One trial, code-named PROCOM, will study a four-drug combination consisting of two nucleoside analogue drugs and two protease inhibitors. It aims to achieve maximal suppression of recipients' viral load initially using the four-drug regimen, but then see whether it is possible to stop taking two of the drugs and keep the viral load suppressed using a less intensive regimen.

The second trial will be an international study of the drug bis-POM PMEA, or adefovir dipovixil. Early studies have suggested that it is active against HIV, CMV and other herpes viruses.

More details on both these trials will be included in AIDS Treatment Update as soon as they are finalised.

INDEX OF STUDY CENTRES

The following centres are taking part in the studies described in this issue of AIDS Treatment Update. The numbers in brackets after the centre's name indicate which studies it is participating in, according to the following key:

(A) Nevirapine trial (described on page 2)

(B) Delavirdine trial (page 3)

(C) Cidofovir open label study (page 5)

(D) Fomivirsen trial (page 5)

Birmingham General Hospital (B) Whittal Street Birmingham B4 6NH Tel: 0121-233 1143 Contact: Dr Sharmanesh

Claude Nicol Centre (A, B, C, D) Royal Sussex County Hospital Eastern Road Brighton BN2 5BE Tel: 01273 664721 Contact: Dr Martin Fisher

Kings College Hospital (A, B) 15-22 Caldecot Road London SE5 9RS Tel: 0171-346 3453 Contact: Dr Anton Pozniak

Mortimer Market Centre (A, B, D) off Capper Street London WC1E 6AU Tel: 0171-380 9740 Contact for delavirdine/nevirapine: Diana Aldam Contact for fomivirsen: Dr Peggy Frith

Kobler Centre (A, B, C, D) Chelsea & Westminster Hospital 369 Fulham Road London SW10 9HT Tel: 0181-746 8000 Contact for delavirdine: Mary Pearson (bleep 4317) Contact for fomivirsen: Sharron Brown (bleep 0452) Contact for loviride: Mark Dalton Contact for nevirapine/cidofovir: Chris Higgs

North Manchester General Hospital (B) Monsall Regional AIDS Unit Delaunays Road Crumpsall Manchester M8 5RB Tel: 0161-720 2729 Contact: Dr Bibhat Mandal

Royal Free Hospital (A, B, C, D) Pond Street Hampstead London NW3 2QG Tel: 0171-794 0500 Contact: Deborah Farmer (bleep 660)

Ruchill Hospital, Glasgow (B) Bilsland Drive Glasgow G20 9NB Tel: 0141-946 5247 Contact: Dr Kennedy

St Bartholomew's Hospital (A) 51-53 Bartholomew Close West Smithfield London EC1A 7BE Tel: 0171-601 7847 Contact: Dr Jackie Parkin

St Mary's Hospital (A) Praed Street London W2 1NY Tel: 0171-725 6738 Contact: Jo Kepple

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