Important note: Information in this article was accurate in August 2002. The state of the art may have changed since the publication date.AIDSWEEKLY Plus; August 5, 2002
Staff Medical Writers
Researchers led by John A. Bartlett, MD, professor of medicine at Duke University Medical Center in Durham, NC, found that at least 75% of never-treated HIV-positive patients had viral loads decrease to the target level of less than 400 copies/mL when treated for 48 weeks using any of three drug combinations.
A viral load greater than 55,000 copies/mL is considered high enough to need treatment; physicians strive to reduce patients' viral loads to below the limits of detection.
"Our preliminary results suggest that even patients with advanced HIV infection can benefit substantially from currently available therapies," said Bartlett. "The challenge to researchers and physicians is to find the combinations that will achieve the best long-term results with the fewest side effects."
These findings represent interim results of the Clinically Significant Long-term Antiretroviral Sequential Sequencing Study (CLASS) sponsored by GlaxoSmithKline. The study was conducted at 43 sites in the United States and Central America.
The CLASS study enrolled 291 HIV-positive patients with initial viral loads greater than 5000 copies/mL. Forty-two percent of the patients had viral loads of more than 100,000 copies/mL at the beginning of the study.
Patients who had previously used antiretroviral treatments for more than two weeks were excluded from the study.
Each patient in the study was prescribed two medications:
Patients also were given a third medication from one of three classes:
At the end of 48 weeks, at least 75% of patients in each of the three groups had viral load measurements of less than 400 copies/mL in these abacavir/lamuvidine containing regimens.
The group of patients using abacavir and lamivudine in combination with an nNRTI (efavirenz) experienced the greatest decline in viral loads, with 75% of patients having viral loads of less than 50 copies/mL at the end of 48 weeks.
Among patients in the nNRTI group with initial viral loads of 100,000 copies/mL or more, 86% had 48-week viral loads of less than 400 copies/mL and 77% had viral loads of less than 50 copies/mL after 48 weeks of treatment.
Patients were switched to a different class of antiretroviral treatment under any of three circumstances: their viral loads failed to reduce to the target level of 400 copies/mL by week 24; their viral loads reduced to 400 copies/mL but rose to more than 1265 copies/mL (as measured at two consecutive visits) after week 24; or if they developed side effects from the medications.
"While patients in the nNRTI group had the greatest reduction in viral loads to less than 50 copies/mL, all three groups showed impressive changes in their viral loads," said Bartlett. "The 96-week results will give us a clearer picture of which group sustains their reduced levels best over time."
A common problem in controlling viral loads is the HIV virus' ability to become resistant to one or more drugs in a patient's regimen, said Bartlett.
Drug resistance can also develop when patients fail to adhere to their medication routine as prescribed, added Bartlett. If patients develop intolerable side effects from medication, they may not use the treatments as prescribed, providing the HIV an opportunity to develop resistance to the drugs, he said.
In this study, 38% of patients in the nNRTI group and 35% of patients in both the PI and NRTI groups experienced moderate to severe side effects, said Bartlett. The most commonly reported side effects were allergic reactions, hypertriglyceridemia, nausea, rash, diarrhea and sleep disorders.
"Side effects are one of the major reasons why patients fail to consistently take their medications as prescribed," said Bartlett. "If we can reduce patients' viral loads using drugs that are tolerable over an extended period of time, then we will have made great strides toward making HIV a chronic disease and helping our patients maintain a high quality of life."
This article was prepared by AIDS Weekly editors from staff and other reports.
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