New US treatment guidelines: Use protease inhibitor combination when starting therapy, says federal panel

New US treatment guidelines: Use protease inhibitor combination when starting therapy, says federal panel

AIDS Treatment Update, Issue 55, July 1997
Edward King

New draft guidelines on the use of anti-HIV drugs drawn up by a panel of American doctors, researchers and treatment activists recommend early, aggressive therapy including a protease inhibitor. The federal guidelines, released as this issue went to press, are likely to be viewed as the new 'gold standard' in HIV therapy, and go further than current British recommendations such as those published by the British HIV Association (see AIDS Treatment Update issue 53).

Treating early

One of the most striking differences is the recommendation that anyone whose CD4 count is below 500 or viral load is above 20,000 (using PCR tests such as Roche's Amplicor test) should consider starting therapy.

Once the decision to start treatment has been taken, the US guidelines also recommend a more aggressive approach than most British clinics are currently practising. Defining the aim of treatment as "maximal suppression of plasma viral load to undetectable levels", the US panel recommends a combination of two nucleoside analogue reverse transcriptase inhibitors (NRTIS) - AZT/ddI, AZT/ddC, AZT/3TC, d4T/ddI or d4T/3TC - plus either indinavir, ritonavir or nelfinavir.

Using saquinavir is defined as a less preferable alternative, because of concerns that the drug is poorly absorbed. Likewise, the panel suggest that other alternative combinations such as two NRTIs plus an NNRTI, or two NRTIs alone, "do not achieve the goal of suppressing viraemia to below detectable levels as consistently as does combination treatment with two NRTIs and a protease inhibitor and should be used only if more potent treatment is not possible".

The panel asserts that "viral load testing is the essential parameter in decisions to initiate or change antiretroviral therapies". Three- to four-monthly tests should be standard practice for all people with HIV. When starting a new treatment regimen, viral load should fall by at least 1 log (ten-fold) by four weeks, according to the US guidelines, and you should consider changing therapy if viral load has not fallen below the limit of detection by six months, or if at any point it increases from undetectable to detectable.

The full 82 page draft documents can be downloaded from the Internet at http://www.hivatis.org/guidelin.html. A summary of their key points can be found at http://aids.miningco.com/library/weekly/aa062297.htm.

The International AIDS Society also published updated treatment guidelines in late June (available on the Internet at http://www.ama-assn.org/special/hiv/library/jama97/st7009.htm). These are very similar to the federal ones, but recommend triple combination therapy for anyone with a viral load above 5,000 to 10,000, regardless of their CD4 count.

In next month's issue, and at the next Treatment Forum (see page 8) we will examine British doctors' responses to the new US approaches to treatment.

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Always watch for outdated information. This article first appeared in 1997. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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