A Randomized Switch From Nevirapine-Based Antiretroviral Therapy to Single Tablet Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in Virologically Suppressed Human Immunodeficiency Virus-1-Infected Rwandans
| العنوان: | A Randomized Switch From Nevirapine-Based Antiretroviral Therapy to Single Tablet Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in Virologically Suppressed Human Immunodeficiency Virus-1-Infected Rwandans |
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| المؤلفون: | Annie Talbot, Philip M. Grant, Sabin Nsanzimana, Sean E Collins, Deborah Slamowitz, Josbert Nyirimigabo, Eric Seruyange, Pierre Dongier, Adeline Mugeni, Simon Pierre Niyonsenga, Jean Paul Uwizihiwe, Eric Remera, Jean-Baptiste Mazarati, Andrew Zolopa, Francois Uwinkindi, Ribakare Muhayimpundu |
| المصدر: | Open Forum Infectious Diseases |
| بيانات النشر: | Oxford University Press, 2016. |
| سنة النشر: | 2016 |
| مصطلحات موضوعية: | 0301 basic medicine, medicine.medical_specialty, Nevirapine, antiretroviral therapy, Human immunodeficiency virus (HIV), Emtricitabine, medicine.disease_cause, law.invention, Major Articles, rilpivirine, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, 030212 general & internal medicine, Adverse effect, business.industry, Rwanda, HIV, randomized clinical trial, 030112 virology, Virology, Confidence interval, 3. Good health, Regimen, Infectious Diseases, Oncology, chemistry, Rilpivirine, business, medicine.drug |
| الوصف: | There is a need to improve antiretroviral options in Africa. This study shows switching from a neviripine-based treatment to co-formulated rilpivirine/emtricitabine/tenofovir disoproxil fumarate in virologically suppressed Rwandans is safe and non-inferior to continued nevirapine-based therapy at 24 weeks. Background. Many human immunodeficiency virus (HIV)-infected patients remain on nevirapine-based antiretroviral therapy (ART) despite safety and efficacy concerns. Switching to a rilpivirine-based regimen is an alternative, but there is little experience with rilpivirine in sub-Saharan Africa where induction of rilpivirine metabolism by nevirapine, HIV subtype, and dietary differences could potentially impact efficacy. Methods. We conducted an open-label noninferiority study of virologically suppressed (HIV-1 ribonucleic acid [RNA] < 50 copies/mL) HIV-1-infected Rwandan adults taking nevirapine plus 2 nucleos(t)ide reverse-transcriptase inhibitors. One hundred fifty participants were randomized 2:1 to switch to coformulated rilpivirine-emtricitabine-tenofovir disoproxil fumarate (referenced as the Switch Arm) or continue current therapy. The primary efficacy endpoint was HIV-1 RNA < 200 copies/mL at week 24 assessed by the US Food and Drug Administration Snapshot algorithm with a noninferiority margin of 12%. Results. Between April and September 2014, 184 patients were screened, and 150 patients were enrolled; 99 patients switched to rilpivirine-emtricitabine-tenofovir, and 51 patients continued their nevirapine-based ART. The mean age was 42 years and 43% of participants were women. At week 24, virologic suppression (HIV-1 RNA level |
| اللغة: | English |
| تدمد: | 2328-8957 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::96a009351b05c1ffc229f048a269da1e http://europepmc.org/articles/PMC5047400 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....96a009351b05c1ffc229f048a269da1e |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 23288957 |
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