AIDSWEEKLY Plus; Monday, December 21, 1998
Daniel J. DeNoon, Senior Editor
Now their patience is exhausted, too.
A new advocacy group, The Coalition for Salvage Therapy, has sent a letter to Abbott Laboratories demanding that the firm immediately begin trials of the drug in heavily pretreated patients. The group, made up of a cross-section of patient-advocacy organizations, asserts that Abbott appears to be reneging on an agreement made at the 1998 World AIDS Conference to expedite such studies.
"Almost six months have passed since your initial commitment to conduct such a study and no visible progress has been made," the letter states. "Such delays are unacceptable when people with HIV continue to be at serious risk of illness and death."
The quickest route to approval for new AIDS drugs is to test them in previously untreated patients. Since all anti-HIV medications must be administered in combination with approved antiretroviral drugs, treatment-naive patients are far more likely to respond to all drugs in the combination. But this approach ensures that the patients most eager to receive new drugs - those who have failed previous regimens - are the last to get them.
"Industry must recognize that confining studies to treatment-naive patients in hopes of maximizing therapeutic effect for rapid approval is not an option," the latter warns. "Such a strategy will trigger widespread hostility, contentious debate, and closer scrutiny of industry practices in general."
The letter acknowledges that Abbott is experiencing serious production problems with ritonavir capsules. ABT-378 is vastly more effective in combination with ritonavir. But the Coalition asks that studies proceed using the liquid formulation of ritonavir.
The group's focus on salvage therapy is no minor quibble. Despite their efficacy, highly active antiretroviral therapy (HAART) regimens have failed in a growing number of patients. Current salvage therapies offer little in the way of long-term efficacy. These patients thus have their eyes fixed on the drug-development horizon, anxiously awaiting new drugs and new hope.
The letter threatens the fragile peace Abbott recently forged with patient advocates.
"Representatives of Abbott have indicated that the company wishes to improve its historically contentious relationship with HIV infected people and their advocates," it notes. "You have expressed a strong desire to create good will and cooperative working relationships with the community. No one wants to see those relationships jeopardized or eroded over this issue, but that surely will happen if evaluation of ABT-378's potential role as salvage therapy is further delayed."
Spearheading the Coalition for Salvage Therapy is Spencer Cox of the New-York-based Treatment Action Group.
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