I’m going to take Joel Gallant (who I greatly admire) and colleagues to task a bit for the *tone* and timing of their just published piece in CID, “Universal Antiretroviral Therapy for HIV Infection: Should U.S. Treatment Guidelines Be Applied to Resource‐Limited Settings?”, which states that “new U.S. guidelines recommending ART for all HIV‐infected patients should not yet be universally applied to resource‐limited settings because of the uncertain safety and efficacy of doing so resulting from disparities in the regimens used, capacity for monitoring, and the ability to provide uninterrupted ART.”
To which I must respond: No fake Jake. Everyone already knows that. But we’ve got to move in the direction of one global standard of care. Why didn’t you rather start of with your concluding discussion about what must be done to remove “the glaring disparities among nations that stand as obstacles to the ethical implementation of early ART.”
We agree on many of the things that must be done:
•”fostering political commitment at a country level to sustain HIV treatment programs, with reduction in dependence on external donor support;
• development of low cost viral load assays to assess adherence and detect virologic failure [point of care preferably – TS];
• increased use of less toxic regimens for first‐line therapy; expansion of options for first‐ and second‐line therapy [and critically third and fourth line -don’t think small -TS] including integrase inhibitors and less toxic protease inhibitors;
• development of less demanding delivery systems that simplify provision of ART for patients and that reduce treatment interruptions; and
• public education about the rationale for initiation of therapy before the onset of symptoms.
Absolutely. Many of us have been working on these things for years. Our goal is to leverage new WHO guidelines (which are not yet the US guidelines of treatment for all PLHIV) to push towards one high global standard of care… not to simply say: “we’re not ready — but rather what must be done to get there within the next few years.”
Which why I’m not so gung-ho on the study idea any more. I have reached the conclusion that it would be a Tuskegee-like experiment… and its conclusions irrelevant the moment countries get additional low cost, simple to administer ART regimens or POC viral load — which must happen in the near future — not 5 years down the road.
The release of this paper is ill-timed, just weeks before the new WHO guidelines come out. The tone is defeatist rather than aspirational. We cannot allow the status quo to continue. We must move forward and the new WHO guidelines move us the first step in that direction. We must take the next.