Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI
| Autor: | Andrea Antinori, Jason Flamm, Douglas J. Ward, Damian J McColl, Mark Bloch, William Garner, Thai Nguyen-Cleary, Kristen Andreatta, Juan Berenguer, Javier Szwarcberg, David Piontkowsky, Pierre Côté, Anton Pozniak |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male 0301 basic medicine Time Factors HIV Infections Quinolones Pharmacology Emtricitabine Nucleoside Reverse Transcriptase Inhibitor law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Antiretroviral Therapy Highly Active Humans Medicine Pharmacology (medical) Patient Reported Outcome Measures 030212 general & internal medicine Tenofovir Reverse-transcriptase inhibitor Drug Substitution business.industry Elvitegravir Cobicistat virus diseases 030112 virology Drug Combinations Regimen Treatment Outcome Infectious Diseases Tolerability HIV-1 Female business Tablets medicine.drug |
| Zdroj: | HIV Clinical Trials. 18:141-148 |
| ISSN: | 1945-5771 1528-4336 |
| DOI: | 10.1080/15284336.2017.1338844 |
| Popis: | HIV-1-infected, virologically suppressed adults wanting to simplify or change their non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens may benefit from switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF).We examined differences in the proportion of participants with HIV-1 RNA 50 copies/mL (Snapshot analysis), change in CD4 cell count, safety, and patient-reported outcomes in participants switching to E/C/F/TDF from an NNRTI + FTC/TDF (TVD) regimen.STRATEGY-NNRTI was a 96-week, phase 3b, randomized, open-label, study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF in virologically suppressed individuals (HIV-1 RNA 50 copies/mL) on an NNRTI + TVD regimen. Participants were randomized to switch or remain on their NNRTI-based regimen (no-switch).At Week 96, 87% (251/290) of switch and 80% (115/143) of no-switch participants maintained HIV-1 RNA 50 copies/mL (difference 6.1%; 95% CI -1.3 to 14.2%; p = 0.12) according to the FDA-defined snapshot algorithm. Both groups had similar proportions of subjects with virologic failure (2.8% switch, 1.4% no-switch). Discontinuations resulting from adverse events were infrequent (3% [9/291] switch, 2% [3/143] no-switch). Three switch participants (1%) discontinued due to renal adverse events (2 of the 3 before Week 48). Switch participants reported significant improvements in neuropsychiatric symptoms by as early as Week 4, and which were maintained through Week 96.E/C/F/TDF is safe and effective and reduces NNRTI-associated neuropsychiatric symptoms for virologically suppressed HIV-positive adults switching from an NNRTI plus FTC/TDF-based regimen. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|