Positive predictive factors in HIV-1 patients treated with enfuvirtide plus an OB that include an active boosted PI. Preliminary FastFuz study results
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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