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  AIDS 2002 Barcelona
Barcelona, Spain July 7-12 2002
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Tenofovir vs D4T 48 Week Study Results: cholesterol, triglycerides
  The news from this study is that d4T treatment group had increased triglycerides by 53 but Tenofovir group had no increase over 48 weeks of therapy. Similarly for cholesterol, patients receiving d4T had increaed cholesterol by 53 compared to 25 for the Tenofovir group.
This is a 48 week study comparing d4T to Tenofovir (Viread) in patients who never before received treatment. In previous studies Tenofovir (TDF) was used for patients with extensive prior treatment experience; and average viral load reductions were about 0.6 log for most individuals. For highly treatment experienced patients, most patients achieve a nice response to TDF. In a short term 15 day monotherapy study TDF has shown to reduce viral load by 1.5 log in treatment naive patients. More data on this study will be presented later today in a poster by Martin Markowitz from Aaron Diamond AIDS Research Center in NYC. Late Breakers on friday will report more on d4T/TDF study.
Patients in this study received efavirenz plus 3TC and TDF once daily or d4T twice daily. Patients also received a TDF or d4T placebo. This is a report after 48 weeks but the study is continuing for 144 weeks. There are about 300 patients in each arm. Patient disposition was about the same in both treatment groups: patients discontinuing study, about 9%, adverse events low, non-compliance, low. For the most part TDF is considered pretty easy to tolerate & take.
48 week Study RESULTS
--87% of patients in both treatment groups had <400 copies/ml (ITT, m=f).
--82% had <50 copies in both groups (ITT, m=f)
--CD4 increases were the same- 169
--19% in each group had grade 3/4 adverse events- low rates
--28-31% had grade 3/4 lab abnormalities- low rates
Mitochondrial Related Toxicities
--3% in TDF & 11% in d4T had events
--2% in TDF group vs 7% in d4T group had peripheral neuropathy
--1% in TDF & 4% in d4T had lipodystrophy
--lactic acidosis: 0% in TDF & 1% in d4T
--pancreatitis 0% in both
--After 48 weeks TRG in creased 74 mg/dL in the d4T group vs no increase in the TDF group
--cholesterol increased 53 mg/dL in d4T group vs 25 in the TDF group