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Tenofovir
in Combination with Lamivudine and Efavirenz in Treatment-naïve
HIV Patients
Study 903 is a
Phase III trial with an ongoing 96-week extension phase (903e) and
a completed 144-week, randomized, double-blind phase designed to
evaluate tenofovir/TDF
(Viread)
compared to stavudine/d4T
(Zerit) in combination with 3TC
(lamivudine; Epivir)
and efavirenz/EFV
(Sustiva) in treatment-naïve HIV-infected
patients.
While both arms provided durable viral suppression
through 144 weeks, patients on the TDF arm experienced significantly
less lipodystrophy and fewer lipid
abnormalities.
All patients in Brazil, Argentina and the
Dominican Republic who completed 144 weeks on study medication were
eligible to roll over to study 903e and receive a once-daily
regimen
of TDF+3TC+EFV. Following are the results on the patients originally
randomized to the TDF arm.
Results
·
86 patients
(62% male, 70% white, mean age 33 yrs) continued treatment with
TDF through 192 weeks.
·
Median
HIV RNA at baseline was 4.8 log10 c/mL, with median CD4 count of
274 cells/mm3. Median time on TDF was 201 weeks.
·
3/86 (3%)
patients discontinued prior to week 192. At week 192, 78/82 (observed
data, 95%) and 78/86 (ITT M=F, 91%) had HIV RNA <400 c/mL; 75/82
(observed data, 92%) and 75/86 (ITT M=F, 87%) had HIV RNA<50
c/mL.
·
Mean increase
from baseline in CD4 was 391 cells/mm3.
·
No patient
reported Fanconi's syndrome or renal
failure.
·
Decreases
from baseline in spine and hip bone mineral density (BMD) by dual
energy x-ray absorptiometry (DEXA) were minimal at week 192 (mean
change from baseline -1.0% in spine BMD and -2.3% in hip) and improved
from week 144.
·
Mean limb
fat measurement by DEXA remained stable from week 96 to week 192
at approximately 8 kg.
The
authors conclude, “Once daily TDF+3TC+EFV demonstrated sustained
antiretroviral activity and was well tolerated in antiretroviral-naïve
patients through 4 years of therapy.”
Fundación Centro Estudios Infectológicos,
Buenos Aires, Argentina, Centro de Referência e Treinamento DST/AIDS,
Sao Paulo, Brazil, Instituto de Infectologia Emilio Ribas, Sao Paulo,
Brazil, Gilead Sciences, Foster City, USA.
08/08/05
Reference
I
Cassetti and others. Tenofovir DF (TDF) in combination with lamivudine
(3TC) and efavirenz (EFV) in antiretroviral-naïve HIV-infected patients:
4-year follow-up. Abstract WePe6.3C05 (poster). Program
and Abstracts of the 3rd IAS Conference on HIV Pathogenesis
and Treatment. July 24-27, 2005. Rio de Janeiro, Brazil.
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