Will NIH Urge New HIV Guidelines Boosting Meds?
1 CommentBy Ed Silverman // October 27th, 2008 // 5:50 pm
A new government-funded study suggests that patients with HIV may have less risk of dying if they begin HAART, or highly active antiretroviral therapy, sooner than current guidelines currently recommend. The existing treatment guidelines call for meds to be considered when CD4+ T-cell counts fall below 350 cells per cubic millimeter.
HIV, you may recall, ravages CD4+ T-cells, which fight off infection, but as virus levels increase, a decrease in CD4+ T-cells occurs. The HAART regimen, which combines at least three HIV meds, is used to reduce virus levels. However, the ideal time to start treatment therapy has been unclear because of insufficient clinical trial data.
And so researchers worked with the International Epidemiology Databases to Evaluate AIDS (IeDEA), which is a global network of clinics that serves HIV patients and collects data, to establish a base for treatment. From 1996 to 2006, they team examined 8,374 HIV-infected study participants with CD4+ T-cell counts of 351 to 500 cells, who had never taken antiretroviral treatment and were free of AIDS-related illnesses (summary statement).
Thirty percent began taking HAART, while the remaining 70 percent deferred treatment until their CD4+ T-cell counts fell below 350 cells. The researchers found a 71 percent higher risk of death for patients who deferred treatment rather than initiating HAART, suggesting that therapy should begin at an earlier stage of HIV disease than currently recommended. However, a randomized clinical trial will be necessary to confirm this finding and support changes to established treatment guidelines.
The implications: new guidelines that, at some point, will boost use of HIV meds, according to Peter Staley of the POZ blog. “The HIV treatment guidelines are very influential on prescription patterns,” he tells us. “It would benefit whatever meds are listed as ‘preferred’ first-line choices in the guidelines, currently Atripla (from Bristol-Myers Squibb & Gilead), Kaletra (Abbott Labs), Truvada (Gilead), and Reyataz (Bristol). At some point soon, Merck’s Isentress will probably get added. The companies most likely to benefit: Gilead (current leader; would benefit the most), Bristol, Abbott, and Merck (might have biggest percentage gain, but still only a one-drug player).”
Hat tip to the POZ blog
Joseph Sonnabend
Merely reporting expert recommendations on the basis of a report of a study that includes few details, may have the effect of persuading patients and their doctors to start anti HIV treatment as early as at a CD4 count of 500. An immediate question for example, which may indeed be answered in the full account of the study, is how many of those with a CD4 count below 350 had counts under say, 100, 50 or even 10. We would not find it surprising that mortality was higher amongst these patients.
To best serve our HIV infected patients we do need to know when to start treating them from evidence derived from prospective studies not on retrospective reviews of records, which can only generate hypotheses. HIV disease is characterized by an enormous variability in individual rates of disease progression. Therefore recommendations about when to start should take individual rates of progression into account.
There have been numerous revisions of guidelines, from the NIH or the International AIDS Society, and these will continue to change. A firm general answer on whether, on average, it’s better to start treatment early or to defer it could have been answered by now had we done the appropriate clinical trials.
One cannot help but note that HIV treatment recommendations are associated with an increase in the amount of drugs prescribed. By discouraging further studies on treatment interruptions, by recommending that these interruptions not be done, and by recommending early treatment. drug sales are increased. It is not difficult to find information on the financial ties to industry of many who make these recommendations, as well as industry support for so called educational entities that ceaselessly disseminate these views.
Starting treatment early, and avoiding treatment interruptions may in fact turn out to be in the patients best interests. But the studies to provide firm information on this have yet to be done.