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Tenofovir/3TC/EFV 4 Yr Followup: limb fat, bones, efficacy
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Reported by Jules Levin
10th European AIDS Conference (EACS)
November 17-20, 2005
Dublin, Ireland
Poster Number PE7.3/13
"Tenofovir DF (TDF) in Combination with
Lamivudine (3TC) and Efavirenz (EFV) in
Antiretroviral-Naïve HIV-Infected Patients:
a 4-Year Follow-Up"
J Enejosa, L Zhong, and AK Cheng for the 903E Study Team
Gilead Sciences Inc., Foster City, California, USA
AUTHOR CONCLUSIONS:
- Once daily TDF+3TC+EFV demonstrated sustained antiretroviral activity and was well tolerated through 4 years of therapy in antiretroviral-naïve patients
- Limb fat measurement remained stable from Week 96 to Week 192
- Decreases from baseline in hip and spine BMD occurred in the fi rst 48 weeks and were non-progressive through Week 192
BACKGROUND:
Study 903 is a Phase III trial with an ongoing 192-week open-label extension phase and a completed 144-week randomized, double-blind phase designed to evaluate TDF compared to stavudine (d4T) in combination with 3TC and EFV in
antiretroviral-naïve patients
While both arms provided durable viral suppression through 144 weeks, patients on TDF arm experienced signifi cantly lower elevations in lipid parameters and higher limb fat compared to d4T1
Both TDF and d4T arms experienced decreases in bone mineral density (BMD) over 144 weeks, which were similar a the hip but greater at the spine for the TDF arm1
Methods:
- Study 903 Main inclusion/exclusion criteria:
- HIV-infected patients naïve to antiretroviral treatment, 18-65 years of age, with plasma HIV RNA >5,000 copies/mL (c/mL)
- No signifi cant laboratory or clinical abnormalities
- No CD4+ cell count criteria
- Patients in select sites (Argentina, Brazil, and Dominican Republic) rolled-over into a 192-week open-label extension phase (903E)
- Data obtained from patients originally randomized to TDF and participating in 903E were analyzed
Figure 1. Study Design
Patient Disposition Through Week 192
- 86 patients enrolled in Study 903 open-label extension phase and continued treatment with TDF
- 3 patients discontinued from the study prior to Week 192
- 1 patient discontinued due to adverse event (Grade 3 amylase/ Grade 4 lipase)
- 1 patient discontinued due to pregnancy
- 1 patient withdrew consent
- No patient reported Fanconi syndrome
- No patient discontinued due to renal abnormalities
- No patient developed K65R mutation through 192 weeks
References
1. Gallant JE, et al. Effi cacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA 2004; 292(2):266-8.
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