Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
PRNewswire - December 18, 2001
"This is the first atazanavir data in protease-inhibitor experienced patients, " said David Haas, M.D., Vanderbilt University Medical Center, Division of Infectious Diseases. "Not only did patients in the atazanavir arm experience rapid viral suppression, but we now know that the favorable lipid profile seen in naive patients taking this drug can be achieved in experienced patients as well, even in the presence of another protease inhibitor."
Analysis of 24-week data from a randomized, active-controlled, blinded study, including 85 patients (AI424-009) compared the safety, efficacy and tolerability of dual protease inhibitor (PI) therapy of atazanavir/saquinavir regimen or ritonavir/saquinavir regimen after virologic failure on a PI regimen. Patients were randomized to receive 400mg or 600mg of atazanavir once-daily with 1200mg of saquinavir once-daily or 400mg of ritonavir twice-daily with 400mg of saquinavir twice-daily, plus two nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Patients enrolled in the atazanavir/saquinavir arm experienced rapid and durable suppression of HIV RNA versus baseline. Groups randomized to receive once-daily doses of 400mg and 600mg reporting week-24 mean HIV RNA level changes of at -1.28 (n=29) and -1.17 (n=22) respectively compared to -1.50 (n=13) in the patients who received 400mg of ritonavir and 400mg of saquinavir, both twice a day.
After 24 weeks, patients enrolled in the atazanavir/saquinavir arms experienced reductions in fasting triglycerides (TG) and total cholesterol (TC) levels compared to the ritonavir/saquinavir arm. In the atazanavir (400mg)/saquinavir and the atazanavir (600mg)/saquinavir arms patients (n=15 and n=13, respectively) experienced 23.2 percent and 22.2 percent mean reductions in TG from baseline, respectively. In the ritonavir/saquinavir arm, patients (n=8) experienced a 90.2 percent increase in fasting TG from baseline.
Similarly, in the atazanavir (400mg)/saquinavir and the atazanavir (600mg)/saquinavir arms, patients (n=27 and n=20, respectively) experienced 0.1 percent and 9.4 percent reductions in TC from baseline. In the ritonavir/saquinavir arm, patients (n=13) experienced an 8.9 percent increase in TC from baseline.
Overall, patients receiving atazanavir/saquinavir experienced no change or a decrease in fasting triglyceride and total cholesterol levels, while those receiving ritonavir/saquinavir experienced marked and sustained elevations in triglyceride and total cholesterol levels. Currently available PI therapy is associated with dyslipidemia, including increased total cholesterol and triglyceride levels, which may be linked to increased cardiovascular risk.
Frequently reported adverse events including diarrhea and nausea were seen more frequently in the ritonavir/saquinavir arm versus the atazanavir (400mg)/saquinavir arm: diarrhea (43 percent vs. 31 percent, respectively), nausea (43 percent vs. 9 percent). Jaundice was reported only in the atazanavir/saquinavir arms (400mg arm; 13 percent, 600 mg arm; 19 percent). Jaundice was resolved upon discontinuation of drug and was not accompanied by changes in liver enzymes. The rate of discontinuation for those patients in the atazanavir/saquinavir arm was 21 percent and 25 percent, respectively, for the atazanavir (400mg)/saquinavir and atazanavir (600mg)/saquinavir arms; the rate of discontinuation for patients in the ritonavir/saquinavir arm was 43 percent.
Atazanavir is being developed by Bristol-Myers Squibb, and is currently in Phase III clinical trials at the once daily dose of 400mg.
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