Dolutegravir-Based or Low-Dose Efavirenz–Based Regimen for the Treatment of HIV-1
| Autor: | Alexandra Calmy, Charles Kouanfack, Sabrina Eymard-Duvernay, Mireille Mpoudi-Etame, Sylvie Boyer, Martine Peeters, Pierrette Omgba Bassega, Eric Delaporte, Sandrine Leroy |
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| Přispěvatelé: | Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques er émergentes (TransVIHMI), Institut de Recherche pour le Développement (IRD)-Université de Yaoundé I-Université Cheikh Anta Diop [Dakar, Sénégal] (UCAD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Université de Montpellier (UM), Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Recherche pour le Développement (IRD), Aiello, Mélisande, Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques et émergentes (TransVIHMI), Calmy, Alexandra, Université Cheikh Anta Diop [Dakar, Sénégal] (UCAD)-Institut de Recherche pour le Développement (IRD)-Université de Yaoundé I-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Université Montpellier 1 (UM1) |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Efavirenz HIV Infections/drug therapy 030204 cardiovascular system & hematology law.invention Tenofovir/administration & dosage 03 medical and health sciences chemistry.chemical_compound Benzoxazines/administration & dosage/adverse effects 0302 clinical medicine Acquired immunodeficiency syndrome (AIDS) Randomized controlled trial immune system diseases Pregnancy law [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases Internal medicine Humans Medicine RNA Viral/blood 030212 general & internal medicine ddc:616 Weight Gain/drug effects business.industry virus diseases Lamivudine General Medicine Heterocyclic Compounds 3-Ring/administration & dosage/adverse effects medicine.disease Viral Load/drug effects Confidence interval HIV-1/genetics/isolation & purification 3. Good health Lamivudine/administration & dosage Regimen chemistry [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology Dolutegravir HIV Integrase Inhibitors/adverse effects/therapeutic use [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases Obesity/chemically induced Drug Therapy Combination Female business Viral load medicine.drug |
| Zdroj: | New England Journal of Medicine New England Journal of Medicine, Massachusetts Medical Society, 2019, 381 (9), pp.816-826. ⟨10.1056/NEJMoa1904340⟩ New England Journal of Medicine, 2019, 381 (9), pp.816-826. ⟨10.1056/NEJMoa1904340⟩ New England Journal of Medicine, Vol. 381, No 9 (2019) pp. 816-826 |
| ISSN: | 0028-4793 1533-4406 |
| DOI: | 10.1056/NEJMoa1904340⟩ |
| Popis: | International audience; BACKGROUND: An efavirenz-based regimen (with a 600-mg dose of efavirenz, known as EFV600) was the World Health Organization preferred first-line treatment for human immunodeficiency virus type 1 (HIV-1) infection until June 2018. Given concerns about side effects, dolutegravir-based and low-dose efavirenz-based combinations have been considered as first-line treatments for HIV-1 in resource-limited settings.METHODS: We conducted an open-label, multicenter, randomized, phase 3 noninferiority trial in Cameroon. Adults with HIV-1 infection who had not received antiretroviral therapy and had an HIV-1 RNA level (viral load) of at least 1000 copies per milliliter were randomly assigned to receive either dolutegravir or the reference treatment of low-dose efavirenz (a 400-mg dose, known as EFV400), combined with tenofovir and lamivudine. The primary end point was the proportion of participants with a viral load of less than 50 copies per milliliter at week 48, on the basis of the Food and Drug Administration snapshot algorithm. The difference between treatment groups was calculated, and noninferiority was tested with a margin of 10 percentage points.RESULTS: A total of 613 participants received at least one dose of the assigned regimen. At week 48, a viral load of less than 50 copies per milliliter was observed in 231 of 310 participants (74.5%) in the dolutegravir group and in 209 of 303 participants (69.0%) in the EFV400 group, with a difference of 5.5 percentage points (95% confidence interval [CI], -1.6 to 12.7; P1000 copies per milliliter) was observed in 3 participants in the dolutegravir group (with none acquiring drug-resistance mutations) and in 16 participants in the EFV400 group. More weight gain was observed in the dolutegravir group than in the EFV400 group (median weight gain, 5.0 kg vs. 3.0 kg; incidence of obesity, 12.3% vs. 5.4%).CONCLUSIONS: In HIV-1-infected adults in Cameroon, a dolutegravir-based regimen was noninferior to an EFV400-based reference regimen with regard to viral suppression at week 48. Among participants who had a viral load of at least 100,000 copies per milliliter when antiretroviral therapy was initiated, fewer participants than expected had viral suppression. (Funded by Unitaid and the French National Agency for AIDS Research; NAMSAL ANRS 12313 ClinicalTrials.gov number, NCT02777229.). |
| Databáze: | OpenAIRE |
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