Oral abstracts of the 10th IAS Conference on HIV Science, 21‐24 July 2019, Mexico City, Mexico
Bibliographic record
Abstract
Background: Double-dose raltegravir is recommended in HIV1infected patients with tuberculosis.A previous phase 2 study showed similar efficacy of standard raltegravir 400 mg BID, raltegravir 800 mg BID, or efavirenz-based regimens.We aimed to assess noninferiority of raltegravir 400 mg BID to efavirenz in HIV1-infected patients with tuberculosis.Methods: ANRS 12300 Reflate TB2 is an open-label, phase 3, randomized trial conducted in Brazil, Côte d'Ivoire, France, Mozambique, and Vietnam.ART-na€ ıve HIV1-infected patients aged ≥18 years on standard tuberculosis treatment for to weeks were randomized (1:1) to receive raltegravir 400 mg BID or efavirenz 600 mg QD both with TDF/3TC 300 mg/300 mg QD.The primary endpoint was the proportion of patients with virologic success at week 48 defined as HIV-RNA ≤50 cp/ml on allocated therapy using the FDA snapshot algorithm.The pre-specified non-inferiority margin was 12%.Results: From September 2015 to January 2018, 230 patients were randomized in each trial arm: 201 (87%) and 203 (88%) completed follow-up in the EFV and RAL arms, respectively.Median age was 35 (IQR: 2 to 3) years, 40% were female, median BMI 19.1 (IQR: 17. to 1.0) kg/m 2 , median CD4 102 (IQR: 38 to 239) cells/μL, median HIV-RNA was 5.5 log (IQR: 5.0 to 5.8), 311 (68%) patients had pulmonary tuberculosis only, and 308 (68%) had bacteriologically-confirmed tuberculosis.In the mITT population, virologic success was achieved: in 134/228 (59%) pts in the raltegravir arm and 135/227 (59%) pts in the efavirenz arm at W24 (end of TB treatment); in 139/ 228 (61%) patients in the raltegravir arm and 150/227 (66%) patients in the efavirenz arm at W48.At W48, the difference between the raltegravir and efavirenz arm was -5.1% (95% CI: -13.9-+3.7),thus not meeting criteria for non-inferiority.Sixty-two (27%) and 77 (33%) patients experienced grade 3 to 4 adverse events in the raltegravir and efavirenz arms, respectively (p = 0.1), including 11 (5%) and 13 (6%) IRIS (p = 0.7).Twelve (5%) patients in the raltegravir arm and 14 (6%) in the efavirenz arm died (Logrank p = 0.7).Conclusions: The non-inferiority of raltegravir 400 mg compared to efavirenz at week 48 was not demonstrated.Raltegravir remains a safe option in combination with tuberculosis treatment.Complementary analyses are necessary to identify determinants of virologic failures in both arms.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.431 | 0.121 |
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".