AIDS Treatment Update, Issue 41, May 1996
Edward King

The protease inhibitor ritonavir is now available in the UK on a named patient basis. This scheme allows doctors to prescribe the drug at their discretion to individuals who might benefit from it. Ritonavir's manufacturer, Abbott Laboratories, has said that it will not charge clinics for drug supplied in this scheme.

Ritonavir is the only protease inhibitor that has yet been shown to reduce symptoms and prolong life, in a six-month study among people with advanced HIV infection.

In order to obtain ritonavir, your doctor must contact Dr Veronica Englishby, Medical Services Manager at Abbott UK on 01628 773355. Once the necessary forms have been completed, the company is able to supply the drug within 48 hours, according to clinics already prescribing ritonavir.

Ritonavir is expected to be formally approved for use by people with advanced HIV infection by the autumn. It will then cost in the region of ú4,000 per year to prescribe.

* Indinavir helpline

Merck, manufacturer of the protease inhibitor indinavir, has set up a helpline for doctors or patients with questions about the drug's availability and effects. The telephone number is 0345 413186.

Indinavir is already available on a named patient basis (see AIDS Treatment Update issue 40). However, Merck is charging clinics about ú3,000 for a year's supply for one patient, which cash-strapped clinics say is hard to find for anyone but patients in the most desparate need.

* 3TC nears approval

The EMEA has authorised 3TC for use in combination with other anti-retrovirals as treatment for HIV infection throughout the European Union.

The agency's scientific advisory committee considered a new pooled analysis of the results of four studies, which reportedly showed that the combination of AZT plus 3TC is more effective at delaying HIV-related symptoms than AZT alone.

Although the committee approved 3TC on April 18, it may take four months before the European Commission issues an official licence allowing Glaxo-Wellcome to market the drug. Until then, the only people able to obtain 3TC will be those already in clinical trials of the drug and those who qualify for the expanded access programme. Access through this programme is officially restricted to those who have failed to benefit from the currently licensed drugs AZT, ddC and ddI.

The European Union licence for 3TC will allow doctors to prescribe 3TC in combination with other anti-retrovirals to anyone with a CD4 count below 500. It will have the brand-name Epivir.

Unfortunately, the information on the clinical benefit of the AZT/3TC combination that encouraged the EMEA to approve 3TC has not yet been made publicly available. However, the new analysis will be published by the European Commission before the drug reaches the market.

* Stavudine available

Stavudine, a nucleoside analogue drug like AZT, is likely to be available on prescription in the UK within weeks, following authorisation by the European Medicines Evaluation Agency.

Stavudine (also known as d4T or by the brand-name Zerit) will be approved for people who are no longer benefiting from AZT, on the basis on a US study which showed that individuals who switched to stavudine after at least six months prior AZT treatment had a significantly reduced risk of developing an opportunistic infection or dying.

Several small pilot studies have suggested that stavudine may also be a useful component of combination regimens. A 14-person study of stavudine combined with ddI found that the drugs suppressed their viral load and boosted their CD4 counts for at least one year.

Stavudine also appears to penetrate the brain more successfully than any other anti-retroviral except AZT. Some doctors are concerned that people who have to stop AZT may no longer be protected against HIV dementia; for these people, stavudine (or a combination containing stavudine) may provide continuing protection against HIV-related brain disorders.

However, no study has taken place to compare the incidence of HIV-related brain disease in people receiving stavudine compared with other drugs.

Stavudine can cause peripheral neuropathy (nerve damage) and pancreatitis, so it may not be suitable for people who already have these conditions or who are taking drugs with similar side-effects.

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