Volume 4 Number 3 April 2003

The annual Conference on Retroviruses and Opportunistic Infections (CROI) remains one of the most important scientific meetings for presentation of new research and this year’s meeting in Boston from 10-14 February was no exception.

As such, we have focused most of this issue of HTB on reporting from that meeting including reports on new agents, antiretroviral strategy, gender studies, generics, treatment in resource-poor settings, metabolic side effects and lipodystrophy.

Two of the bigger general news stories this month, appropriately included in ‘other news’, were the results from the VaxGen vaccine trial, and the approval (in the USA) and pricing (in Europe) for Roche/Trimeris fusion inhibitor T-20.

The VaxGen results are undoubtedly disappointing but did not come as a surprise to most researchers. The impressive logistical difficulties of running a large preventative vaccine trial, including ethical barriers, were nevertheless overcome. This was somewhat overshadowed by the company’s emphasis on benefits shown in the small numbers of African-American and Asian people in the study. The tiny numbers involved, and indeed the calculation of statistical significance that has since been challenged, were effectively highlighted by community reports. We are left to wait until the results of the Thailand study expected in a few months time, to see whether this leads to any benefit in practice.

T-20 is the first ‘new-class’ drug to be approved since 1996 and the significant scientific and medical advances implicit in its development have been largely overtaken by the issue of cost – at $20,000 per year this is at least three times higher than the most expensive current drugs.

Development costs were undeniably high, and if Roche hadn’t partnered early with Trimeris and run with the many uncertainties of a subcutaneously administered drug, we wouldn’t have seen the compound introduced into clinical care for many years.

T-20 will work against all virus resistant to current treatments, but like all drugs, for long-term benefit requires support from other active agents in a combination. Strictly speaking, this implies use earlier in treatment failure and at least in third-line therapy.

The UK has been relatively sheltered from individual drug costs for HIV, and also thankfully sheltered from National Institute of Clinical Excellence (NICE), but there is no guarantee that this will continue. Restructuring healthcare through Prmary Care Trusts is likely to mean that everything now comes from the same pot and there has still been no government recognition that increasing numbers of new infections and reduced mortality in itself requires an increasing annual drug budget.

Although still easily justifiable by health economic analysis, there is a concern that cost may be used as a factor to delay use of T-20. In practice, instead of becoming a possible drug for many patients to successfully control viremia and reduce further resistance, it may become used only sparingly and in salvage situations.

The implications for other markets, notably the USA where many ADAP and Medicaid programmes already have closed waiting lists are unclear but indications of the concern from patients dependent on these programmes are provided in linked articles for this story.