Being Alive Newsletter, Being Alive/Los Angeles - July 1993
Walt Senterfitt

The new recommendations supplant those issuing from a similar state of the art conference in 1990, the conference which led to the always-questionable norm of starting AZT in asymptomatic HIV+ people whose T4 cell count dropped under 500. As I have reported earlier, many respected clinicians never accepted this norm (including most of those in Europe) preferring to wait until symptoms appeared or until the T4 cell count became much lower. And many of them supported those patients who chose never to use these drugs at all. New and pessimistic data, most notably but not limited to the Concorde study, supports in the main the more conservative approach.

The new guidelines are more modest, reflect a realistic pessimism about this class of drugs, and counsel an individual approach to each person's therapy based on teamwork between doctor and patient which assesses each individual's needs, priorities and circumstances of daily life. The panel emphasized that the choice to accept or decline antiretroviral therapy at any stage of infection must rest decisively with the patient.

The panel also emphasized another critical point: "early intervention" should not be equated with giving drugs to stable and asymptomatic patients. Instead, early intervention should be understood to comprise primary medical care, optimization of overall health status including nutrition, emotional and psychological support, and access to usable information about available drug choices.

SUMMARY OF RECOMMENDATIONS

If a person has never taken antiretroviral therapy before:

- for those with T4 cell counts greater than 500 observation and T4 counts every six months;

- for those with T4 counts 200 to 500 and who are asymptomatic and stable over time either initiation of antiretroviral therapy or continued observation and monitoring for evidence of deteriorating status, at which point antiretroviral therapy should be started;

- for those with T4 counts 200 to 500 with HIV-related symptoms, the panel recommends starting antiretroviral therapy.

When choosing which drug(s) to start with, the panel recommends:

- AZT 600 mg/day in divided doses as first-line therapy for those who have received no prior antiretroviral therapy; this recommendation applies to all those deciding to start antiretroviral therapy, regardless of T4 count, symptom status, or diagnosis;

- combination therapy with AZT/ddI or AZT/ddC also may be considered, though clinical trials have not conclusively demonstrated clinical benefit of combination therapy so far.

On changing initial therapy in patients who are still tolerating that initial antiretroviral therapy, the panel recommends:

- in persons who started on AZT and who appear to be stable with T4 counts over 300, continue with AZT;

- in those with T4 counts below 300, the panel recommends explicitly considering two options either continuing AZT or changing to ddi; the panel noted the strongest data supporting a change to ddi were in patients who had been on AZT for at least four months (median of 13 months of prior AZT).

For persons intolerant of AZT, or whose disease progresses while taking it, the panel recommends:

- for those intolerant of AZT, if T4 counts between 50 and 500, switch to ddI monotherapy; if T4 count less than 50, switch to either ddI or ddC; in either case, another valid option is to stop antiretroviral therapy altogether;

- for those who are progressing anyway and have T-counts between 50 and 500, start an alternative antiviral regimen, either by changing to another single agent or combination;

- for those progressing with less than 50 T4 count, switch to another single drug.

For those with more than 500 T4 count, who are taking AZT and experience intolerance, discontinue antiretroviral therapy.

SIGNIFICANCE

These guidelines have no force by themselves, but are likely to eventually influence physician practice, especially after they are published in final form with supporting evidence in a peer-reviewed medical journal. It is likely to encourage those physicians away from major metropolitan areas or with fewer HIV+ patients to recommend these drugs more sparingly and critically. Less change would be expected from those in large HIV practices whose patients tend to already be fairly critical of nucleoside analogs. Even some of these clinicians, though, could benefit from a brake on their tendencies to heavily encourage patients to use antiretrovirals.

The fundamental point underlying this official reassessment (which some consider belated) is that we do not have any antiviral drugs currently available that are anywhere near effective. Those who relied on AZT/ddI/ddC if for no other reason than that a little something is better than nothing are now having to acknowledge how little that is, and always has been.
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