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 machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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 source (direct Gemma or distilled Codex), 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".