AIDSWEEKLY Plus; Monday, August 10 & 17, 1998
Daniel J. DeNoon, Senior Editor
For HIV disease-management strategies, it's still an open question. And the answer has implications for the treatment of other chronic viral infections such as hepatitis, herpes, and papilloma viruses.
Given that current drugs cannot eradicate HIV, the question becomes whether to give the most highly suppressive regimens as soon as possible - to asymptomatic patients - or to save them until disease symptoms occur. Reports at the 12th World AIDS Conference, held June 28-July 3, 1998, in Geneva, Switzerland, offered support to both sides of the debate.
The "hit early, hit hard" strategy would provide potent early treatment to relatively healthy patients with little immune damage. This strategy follows David Ho's "It's the virus, stupid" model of HIV pathogenesis, which predicts that control of the virus is the cornerstone of AIDS therapy.
Supporting this concept is data from long-term non-progressors (LTNPs) - individuals who remain asymptomatic despite HIV infection of 10 years or more. The pattern of low virus load and normal T-cell counts seen in patients treated early with highly active antiretroviral therapy (HAART) regimens is similar to that seen in the LTNPs. It is hoped that early treatment can improve the viral and immunologic setpoints of "steady-state" latent HIV infection.
Moreover, there is some evidence that early, aggressive treatment is associated with a survival advantage over delayed treatment.
These and other findings have led many researchers to suggest that if one protease inhibitor (PI) is good, two would be better. And several reports at the 12th World AIDS Conference showed that Abbott's ritonavir is particularly attractive in these dual PI regimens, with demonstrable synergistic anti-HIV effects.
But the main story of the AIDS conference has been reports of serious metabolic side effects - including diabetes and a disfiguring fat wasting/accumulation syndrome - from HIV protease inhibitors. These disturbing reports led to media rediscovery that people on drug maintenance can develop serious side effects.
Unfortunately for Abbott, the early impression - yet to be confirmed - is that this PI-associated lipodystrophy seems to be worse in patients receiving ritonavir.
By happy coincidence the AIDS conference also featured evidence that the right combination of AIDS drugs - notably Bristol/Myers Squibb's stavudine/didanosine/hydroxyurea (d4T/ddI/HU) combination - can deliver a very strong and sustained anti-HIV punch without relying on a single protease inhibitor. The sensational publicity given the side effects of protease inhibitors is sure to favor such "protease- sparing regimens."
Immunologists suggest that HIV pathogenesis may be a complex process in which small, disseminated HIV infections in localized lymphoid tissues drive the disease. If this is so, then filling the blood with potent antiretrovirals may fail over time: a hypothetical but highly disturbing possibility that provides additional rationale for delaying PI therapy.
By the next AIDS conference, scheduled for the year 2000 in Durban, South Africa, there may be enough long-term data to determine which approach to AIDS therapy is most beneficial to the patient. Until then, at least, practitioners and their HIV infected patients have some hard decisions to make.
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