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HIV Health and Treatment Issues >> Treatment & Side Effects

TwinsDad
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Reged: 07/13/05
Posts: 27
Loc: USA
Early HIV Treatment Failure Linked to Didanosine/T
      08/30/05 11:26 PM

NEW YORK (Reuters Health) Aug 23 - The combination of the antiretroviral agents didanosine, tenofovir, and efavirenz is associated with a high virological failure rate in treatment-naive patients with HIV, British investigators report.

Dr. Desmond Maitland and colleagues at Chelsea and Westminster Hospital in London had planned a 48-week trial comparing lamivudine (n = 36) and tenofovir disoproxil fumarate (n = 41), both in combination with didanosine and efavirenz.

As reported in the July 22nd issue of AIDS, in the lamivudine group, drug dosages were 300 mg daily for lamivudine and 400 mg daily for didanosine. In the tenofovir group, the dosages were tenofovir 300 mg daily and didanosine 250 mg daily. In both groups, efavirenz dose was 600 mg daily.

Dr. Maitland's group terminated the study at week 12 when an unplanned interim analysis revealed five virological failures (12.2%) in the tenofovir group (failure to suppress HIV RNA by at least 1 log10 by week 4 in three cases, virological rebound in one case, and emergence of genotypic resistance in one case).

There were no treatment failures in the lamivudine group.

The investigators note that the five patients with treatment failure had baseline CD4+ counts of less than 200 cells per microliter and HIV-1 RNA greater than 100,000 copies/mL.

"Virological failure...could not be attributed to problems with baseline resistance, efavirenz exposure or subject adherence," the researchers report.

They note that another recent study showed a similar problem with virological failure in antiretroviral-nave patients.

As to reasons for the treatment failures, the authors hypothesize that "combinations including nucleoside/nucleotide backbones with low genetic barrier to resistance may be more vulnerable if they are combined with a third agent characterized by a wide inter-individual variability in plasma concentrations."

Or, they add, the lack of efficacy may be due to the pathway of activity shared by both tenofovir and didanosine.

"Whatever the cause," the investigators conclude, "it is clear that tenofovir/didanosine should be used with caution as a nucleoside/nucleotide backbone."

AIDS 2005;19:1183-1188.



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* Early HIV Treatment Failure Linked to Didanosine/T TwinsDad 08/30/05 11:26 PM
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