Tenofovir-Based Preexposure Prophylaxis for HIV Infection Among African Women
Notice bibliographique
Résumé
Reproductive-age African women and others at high risk of acquiring human immunodeficiency virus type 1 (HIV-1) infection need effective interventions to prevent acquisition of this virus. Previous studies have demonstrated that daily oral pre-exposure prophylaxis with tenofovir disoproxil fumarate (TDF) alone or TDF combined with emtricitabine (FTC) (TDF-FTC) reduces the risk of HIV transmission by at least 50% in men who have sex with men, heterosexuals, and injection-drug users (with greater effectiveness in subjects with high adherence to the regimen). However, daily tenofovir (TFV)–based regimens were found to be ineffective in preventing HIV-1 acquisition among women in the Preexposure Prophylaxis Trial for HIV Prevention among African Women (FEM-PrEP) when adherence to the regimen was less than 40%. The Vaginal and Oral Interventions to Control the Epidemic (VOICE) trial was a randomized, placebo-controlled trial that assessed the effectiveness of daily treatment with oral TDF, oral TDF-FTC, or 1% TFV vaginal gel in preventing sexually acquired HIV-1 infection in women in South Africa, Uganda, and Zimbabwe. Adverse effects of the regimens were also assessed. Monthly HIV tests and quarterly blood testing were performed. From September 2009 through June 2011, 12,320 women were screened at 15 sites in South Africa, Uganda, and Zimbabwe. Of these, 5029 were enrolled in the study and randomized. Retention in the trial was excellent; 91% of women completed follow-up visits. The primary effectiveness end point, HIV-1 infection, was identified by seroconversion and assessed in a modified intention-to-treat population. There were 312 HIV-1 infections among study participants; the incidence of infection was 5.7 per 100 person-years. None of the TFV-based regimens were effective in reducing HIV-1 transmission: effectiveness was −49.0% for TDF alone (hazard ratio [HR] for infection, 1.49; 95% confidence interval [CI], 0.97–2.29), −4.4% for TDF-FTC (HR, 1.04; 95% CI, 0.73–1.49), and 14.5% for TFV gel (HR, 0.85; 95% CI, 0.61–1.21). Adherence appeared to be high (86%) based on women's returns of empty pill boxes and gel applicators. However, measurable drug plasma levels in random samples were only 30% for TDF, 29% for TDF-FTC, and 25% for TFV gel. Independent predictors of adherence included being married, being older than 25 years, and being multiparous. There were elevated serum creatinine levels more frequently among participants who received oral TDF-FTC compared with oral placebo (1.3% vs 0.2%, P = 0.004). No significant differences were noted in the frequencies of other adverse events. Consistent with the findings of other studies, these data show that TDF-based regimens proven to prevent HIV infection are ineffective when adherence is poor.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».