Positive predictive factors in HIV-1 patients treated with enfuvirtide plus an OB that include an active boosted PI. Preliminary FastFuz study results
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KeywordsViral Load Active Drug Median Increase Median Baseline Enfuvirtide
TORO studies defined four positive predictive factors (PPF) at baseline: viral load (VL) <100,000 copies/mL, CD4+ cell count >100 cells/mL, previous experience to <10 ARVs, and >2 active drugs in the ARV regimen. The most important of these factors (>2 active drugs) was an inclusion criteria in this study.
Cross-sectional, multicentre study to redefine the PPF of response in clinical practice after 12 weeks of ARV therapy, with ENF and at least one active boosted IP.
Summary of results
A total of 146 HIV-1-infected patients with viral failure were evaluated. Patients were mainly male (75.3%), median age 42 years. Median time of ENF treatment was 13 weeks. Median baseline characteristics: VL 4.28 log10 cop/mL, CD4 cell count 191 cells/mL, four previous IPs and four previous RTIs. TPV/r and DRV/r was used by 40.4% and 35.6% of patients, respectively. Patients with CD4 count >100 cells/mL were 74% and patients viral load (VL) <100,000 copies/mL 83.6%. Patients with two or more active drugs in OBT were 63.2% and with previous experience to <10 ARVs were 67.6%. Overall response defined by protocol (decrease 1 log at week 12 or VL<50 cop/ml) was 88.7%. Median increase in CD4 cells count was 67 cells/mL. PPF related to VL<50 copies/mL were baseline VL<100,000 copies/mL (p < 0.005) and baseline CD4>100 cells/mL (p < 0.05).
Enfuvirtide plus one active boosted PI led to a high percentage of response (88.8%) with 57.5% of patients reaching virological suppression <50 copies/mL after 12 weeks of treatment. PPF related to response were VL<100,000 copies/mL and CD4>100 cells/mL. These results reinforce the idea of rescuing failing patients early (with high CD4 cells and low VL) and with at least two active drugs.
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