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The Body Covers: The 12th International AIDS Conference

Another Protease-Sparing Treatment Option

Coverage provided by Ian Frank, M.D.

June 30, 1998

This study assessed the activity and tolerability of open-label therapy with the combination of stavudine (d4T), didanosine (ddI), and nevirapine (NVP) in patients with and without prior treatment experience. Nine antiretroviral naive patients were enrolled, together with 39 patients who had been treated with a protease inhibitor. Only 10% of the experienced patients were naive to all three drugs -- 79% had prior therapy with d4T, 31% with ddI, and 10% with NVP. Reasons for stopping therapy with a protease inhibitor included rebound in viral load in 50%, side effects in 37%, and more convenient dosing in 18%.

Mean baseline viral loads were high in these patients, about 150,000 copies/mL in the naive patients, and 280,000 copies/mL in the experienced patients. After 26 weeks of therapy, six of eight naive patients had viral loads < 400 copies/mL, and 18/29 (62%) of experienced patients. The proportion of experienced patients with viral loads < 400 copies/mL was related to the number of new drugs the patients received. If the patient was naive to all three drugs, four of four patients had viral loads < 400 copies/mL, compared to 11/19 (58%) who were receiving two new drugs, and 6/10 (60%) who were receiving only one new drug. Six patients were prematurely discontinued from study due to elevated liver transaminases and two because of peripheral neuropathy.

The number of naive patients in this study is small, but suggests that the combination of d4T, ddI, and NVP is as active as other NVP inclusive combinations with two other nucleoside reverse transcriptase inhibitors. For patients who can not tolerate a protease inhibitor, this combination represents a good alternative. As is true for all salvage regimes, the best chance to reduce a patient's viral load to less than quantifiable levels is when all new agents are given with the "salvage" regimen.

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