Enfurvirtide, an HIV-1 Fusion Inhibitor, for Drug-Resistant HIV Infection in North and South America
Bibliographic record
Abstract
Enfurvirtide, an HIV-1 Fusion Inhibitor, for Drug-Resistant HIV Infection in North and South America Lalezari JP et al. N Engl J Med. 2003;348:2175 The authors report the results from a randomized, open-label, phase 3 study of enfurvirtide (T-20) for patients who failed therapy with all three antiretroviral classes. Enrollment criteria was treatment for at least 3 to 6 months with all three antiretroviral drugs, documented resistance to all three classes and a viral load >5,000 c/mL. Patients were randomized 2:1 to receive the study drug added to the optimized background regimen of 3–5 antiviral drugs selected on the basis of treatment history and resistance tests. Controls received the optimized regimen without T-20. The study was done at 48 sites in the US, Canada, Mexico, and Brazil with 501 participants. Results, analyzed at 24 weeks, showed the participants in this trial were a heavily treated group with an average exposure to 12 antiretroviral drugs over about 7 years, a median viral load >30,000 c/mL and median CD4 count <100 cells/mm3 in each arm; about 85% had a previous AIDS-defining diagnosis. The results showed a significantly better virologic response and CD4 cell count response in those given T-20 compared to controls. The reduction in viral load was nearly one log greater in the group given T-20. Nearly all patients (98%) had injection site reactions, primarily erythema and induration with nodules and cysts; about 9% required analgesics or had limited activities, but none required hospitalization. The authors concluded that T-20 provides significant antiretroviral and immunologic benefit to patients who have had extensive previous antiretroviral therapy with failure involving multidrug-resistant strains of HIV. The results are summarized in the following table:TableComment: See below.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".