Dual therapy (ritonavir boosted atazanavir+raltegravir) versus standard triple therapy (ritonavir boosted atazanavir+tenofovir/emtricitabine) in patients failing first line therapy: 48 week results from a randomized pilot study
| dc.contributor.author | Sued, Omar | |
| dc.contributor.author | Figueroa, MI | |
| dc.contributor.author | Cesar, Carina | |
| dc.contributor.author | Patterson, Patricia | |
| dc.contributor.author | Yamamoto, C | |
| dc.contributor.author | Fink, N | |
| dc.contributor.author | Gun, Ana | |
| dc.contributor.author | Cahn, Pedro | |
| dc.date.accessioned | 2024-05-23T23:49:51Z | |
| dc.date.available | 2024-05-23T23:49:51Z | |
| dc.date.issued | 2018-08 | |
| dc.description | Fil: Sued O. Fundación Huésped, Buenos Aires; Argentina | es_ES |
| dc.description | Fil: Figueroa MI. Fundación Huésped, Buenos Aires; Argentina | es_ES |
| dc.description | Fil: Cahn P. Fundación Huésped, Buenos Aires; Argentina | es_ES |
| dc.description.abstract | Background: Dual therapy has emerged as a novel concept in treatment optimization in naive and supressed HIV patients. This study aimed at exploring virological response, safety and inflammation markers of a nucleoside-sparing dual regimen consisting of ATV/r + RAL (DT) vs standard therapy of ATV/r + TDF/FTC (TT) among patients failing first NNRTI-containing treatment. Methods & Materials: Randomized open label pilot study. Primary outcome measures were proportion of subjects with plasma HIV-1 RNA below the limit of detection (<50 copies/uL) and proportion of subjects discontinuing due to adverse events (AEs) during the first 48 weeks. ClinicalTrials.gov Identifier: NCT01829802. Results: Out of 57 patients screened, 34 were randomized to receive: DT (n: 18) or TT (n: 16). At baseline 80% males, 50% MSM, median age 38 years, CDC stage C:35%, Median pVL: 3.9 Log10, CD4: 289 cells/uL. At week 48, data from 32 participants (2 did not reach week 48 yet) showed virological response in 69% (n: 11/16) of participants receiving DT and 88% (n: 14/16) receiving TT by FDA snapshot analysis (p = NS) and 73% (DT) and 93% (TT) by per-protocol analysis (p = NS). CD4 cell count median change from baseline to week 48 was +119 and + 52 cell/uL in DT and TT, respectively. No deaths were recorded. Three SAEs occurred in 2 participants (pneumonia and stroke and, Belĺs paralysis), none related to study drugs. Eight Grade 2, probably drug-related AEs were observed: 1 in DT (gastrointestinal) and 7 in TT (5 gastrointestinal, 1 renal stone and 1 rash). Hyperbilirubinemia Grade 2/3 was seen in 77% in DT and 94% in TT, none requiring stopping ART. Two participants were discontinued due to loss of follow-up, one in each arm. Five participants had virological failure at W48, 4 in DT and 1 in TT, all with low pVL (52-589 copies/uL). One participant developed integrase resistance mutation and suppressed later on TT. Conclusion: ATV/r+RAL as second-line therapy showed a trend to more frequent virological failure, compared to TT, although the study was unpowered to prove this difference. No major differences were seen in tolerance or toxicity. | es_ES |
| dc.format | application/pdf | es_ES |
| dc.identifier.doi | https://doi.org/10.1016/j.ijid.2018.04.3476 | |
| dc.identifier.uri | https://repositorio.huesped.org.ar/handle/123456789/1405 | |
| dc.language | ENG | es_ES |
| dc.provenance | Published | es_ES |
| dc.relation.ispartofseries | International Journal of Infectious Diseases;2018 Aug 23;vol 73 | |
| dc.rights | openAccess | es_ES |
| dc.subject | Ritonavir | es_ES |
| dc.title | Dual therapy (ritonavir boosted atazanavir+raltegravir) versus standard triple therapy (ritonavir boosted atazanavir+tenofovir/emtricitabine) in patients failing first line therapy: 48 week results from a randomized pilot study | es_ES |
| dc.type | Articulo | es_ES |