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10/28/2003

Triple NRTI Regimen Fails to Control HIV

Kate Traynor

A bulletin issued last week by the Food and Drug Administration's (FDA's) MedWatch adverse-event reporting system warns that a once-daily regimen of didanosine, lamivudine, and tenofovir disproxil sulfate is ineffective at controlling HIV infection.

According to a Dear Health Care Professional letter from Gilead Sciences Inc., a small study in HIV-infected patients who were new to treatment revealed that fewer that one in 10 achieved the desired level of viral suppression on the therapeutic regimen. Resistance testing demonstrated that nearly all patients had virus containing the M184I/V resistance mutation, and half had the K65R resistance mutation as well.

Gilead warned that the regimen is inappropriate for patients who have already undergone antiretroviral therapy as well as patients who are new to treatment. The company stated that a change in treatment should be considered for patients who are already taking the antiretroviral regimen.

According to Gilead, the ineffectiveness of this particular nucleoside reverse-transcriptase inhibitor (NRTI) regimen mirrors problems recently reported with other triple NRTI combinations.