"MOST IMPORTANT TRIAL RESULTS EVER": What makes the results of Delta so significant?

"MOST IMPORTANT TRIAL RESULTS EVER": What makes the results of Delta so significant?

AIDS TREATMENT UPDATE, October 1995
Edward King

For years there has been what is, to the non-medic, a striking divide between the views of different AIDS doctors. In the light of Concorde, which found no advantage to 'early intervention' with AZT monotherapy, some stressed the lack of evidence of any benefits from beginning anti-HIV treatment before symptoms occur. Others argued that AZT monotherapy was simply too weak and that combinations of anti-HIV drugs were likely to more effective. To them, Concorde stressed the need to do more, rather than to do nothing.

Until very recently there was no hard evidence that one approach was any better than the other. But now the results of Delta indicate that people who start anti-HIV treatment with combination therapy before they develop symptoms can expect to derive clear benefits in terms of a reduced risk of developing AIDS and a reduced risk of dying.

Delta is the first trial of anti-HIV drugs to show such a clear-cut survival benefit. Dr Brian Gazzard, the trial's UK Principal Investigator, said "We were very surprised at the extent of the effect. This is the first study with long-term follow-up in which survival has been changed dramatically. It establishes once and for all that anti-retroviral drugs can prolong life."

The success of Delta also has implications for researchers who are planning trials of anti-HIV drugs. In recent years there has been controversy between those who believe that long-term trials with clinical endpoints, like Delta, are necessary if we are to have clear knowledge about the effects of treatments, and those who argue that short-term trials using markers such as CD4 counts or viral load as endpoints will suffice. In Delta, the difference in survival only became apparent after people had been treated for at least 18 months, so a short-term trial would not have been able to detect it. "The idea that you only need to do surrogate marker trials is blown sky high by Delta", says Dr Gazzard. "Delta shows how important clinical endpoint studies are."

Delta will also produce information on the effects of the treatments on markers such as CD4 count and viral load, although these results are not available yet. One of the researchers' priorities is to try to establish whether changes in certain markers can be used to predict who will experience clinical benefits.

AIDS Treatment Update spoke to doctors spanning the previous divide in opinions, and found that all agree that Delta is probably the most important trial of anti-HIV treatments ever. "These are dramatically important results for the treatment of AIDS", says Dr Gazzard. "We are immensely grateful to the trial participants. By taking part in Delta they will have helped to markedly change the way all people with HIV are treated."

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