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Efficacy and Safety of Once-daily Combination Therapy with Didanosine,
Lamivudine and Nevirapine in Treatment-naive HIV Patients
Simplified antiretroviral
regimens lead to improved patient adherence to therapy and as a result, improve their
quality
of life. The purpose of the present study was to evaluate the efficacy and
safety of a once-daily regimen consisting of didanosine/ddI
(Videx),
lamivudine/3TC
(Epivir) and nevirapine/NVP
(Viramune) for adult treatment-naive patients with
HIV infection.
This
was a prospective, one-arm, multicenter pilot study. Daily drug
dosage was 250 or 400 mg didanosine, 300 mg lamivudine and 400 mg
nevirapine. The primary outcome measure was the percentage of patients
with a plasma HIV-RNA level <50 copies/ml at 12 months on an
intention-to-treat (ITT) basis.
Results
· Seventy
patients were enrolled in the study.
· At
baseline, mean plasma HIV-1 RNA was 5.10 log10 copies/ml, and mean
CD4
cell count
was 262 cells/µl.
· At
month 12, 67% of patients maintained a viral load of <50 copies/ml
in the ITT analysis and CD4 counts increased a median of 201 cells/µl.
· The
treatment was more effective in patients with baseline CD4 counts
>100 cells/µl than in those with a poorer immunological status
at baseline, although the number of patients with CD4 counts <100
was low.
· Four
patients died during the study period.
· Therapy
was discontinued in 18 patients due to virological
failure
in 11, adverse
events in seven, loss to follow-up or withdrawal of consent in four and
death in one.
· Eight
out of nine patients with available genotype after virological failure showed resistance
mutations to NVP (Y181C and others) and 3TC (M184V/I), and four of them also
had ddI resistance (L74V).
· The
lipid profile was favorable, with a decrease in the ratio of total-to-high
density lipoprotein cholesterol.
In
conclusion, the authors write, “A once-daily combination of ddI,
3TC and NVP seems to be an effective, safe and easy-to-take regimen
in antiretroviral-naive patients, at least in those who do not have
severe immuno-depression at baseline.
09/23/05
Reference
E
Ribera and others. Efficacy and safety of once-daily combination
therapy with didanosine, lamivudine and nevirapine in antiretroviral-naive
HIV-infected patients. Antiviral Therapy 10(5): 605-614.
September 2005.
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