Dolutegravir–lamivudine as initial therapy in HIV-1 infected, ARV-naive patients, 48-week results of the PADDLE (Pilot Antiretroviral Design with Dolutegravir LamivudinE) study
| dc.contributor.author | Cahn, Pedro | |
| dc.contributor.author | Rolón, María José | |
| dc.contributor.author | Figueroa, María Inés | |
| dc.contributor.author | Gun, Ana | |
| dc.contributor.author | Patterson, Patricia | |
| dc.contributor.author | Sued, Omar | |
| dc.date.accessioned | 2024-03-05T02:24:49Z | |
| dc.date.available | 2024-03-05T02:24:49Z | |
| dc.date.issued | 2017-01-01 | |
| dc.description | Fil: Cahn P. Fundación Huésped, Buenos Aires; Argentina | es_ES |
| dc.description | Fil: Rolón MJ. Fundación Huésped, Buenos Aires; Argentina | es_ES |
| dc.description | Fil: Figueroa MI. Fundación Huésped, Buenos Aires; Argentina | es_ES |
| dc.description | Fil: Gun A. Fundación Huésped, Buenos Aires; Argentina | es_ES |
| dc.description | Fil: Patterson P. Fundación Huésped, Buenos Aires; Argentina | es_ES |
| dc.description | Fil: Sued O. Fundación Huésped, Buenos Aires; Argentina | es_ES |
| dc.description.abstract | Introduction: A proof-of-concept study was designed to evaluate the antiviral efficacy, safety and tolerability of a two-drug regimen with dolutegravir 50 mg once daily (QD) plus lamivudine 300 mg once daily as initial highly active antiretroviral therapy (HAART) among antiretroviral (ARV)-naive patients. Methods: PADDLE is a pilot study including 20 treatment-naive adults. To be selected, participants had no IAS-USA-defined resistance, HIV-1 RNA ≤100,000 copies/mL at screening and negative HBsAg. Plasma viral load (pVL) was measured at baseline; days 2, 4, 7, 10, 14, 21 and 28; weeks 6, 8 and 12; and thereafter every 12 weeks up to 96 weeks. Primary endpoint was the proportion of patients with HIV-1 RNA <50 copies/mL in an intention to treat (ITT)-exposed analysis at 48 weeks (the FDA snapshot algorithm). Results: Median HIV-1 RNA at entry was 24,128 copies/mL (interquartile range (IQR): 11,686–36,794). Albeit as per protocol, all patients had pVL ≤100,000 copies/mL at screening as required by inclusion criteria, four patients had ≥100,000 copies/mL at baseline. Median baseline CD4+ T-cell count was 507 per cubic millimetre (IQR: 296–517). A rapid decline in pVL was observed (median VL decay from baseline to week 12 was 2.74 logs). All patients were suppressed at week 8 onwards up to week 24. At week 48, 90% (18/20) reached the primary endpoint of a pVL <50 copies/mL. Median change in CD4 cell count between baseline and week 48 was 267 cells/mm3 (IQR: 180–462). No major tolerability/toxicity issues were observed. Nineteen patients completed 48 weeks of the study, and one patient (with undetectable VL at last visit) committed suicide. One patient presented a low-level protocol-defined confirmed virological failure at week 36, being the only observed failure. This patient had pVL <50 copies/mL at the end-of-study visit without having changed the two-drug regimen. Observed failure rate was 5%. This is the first report of integrase strand transfer inhibitor/lamivudine dual regimen in ARV-naive patients. Conclusions: This novel dual regimen of dolutegravir and lamivudine warrants further clinical research and consideration as a potential therapeutic option for ARV-therapy-naive patients. ClinicalTrials.gov Identifier: NCT02211482. | es_ES |
| dc.format | application/pdf | es_ES |
| dc.identifier.doi | https://doi.org/10.7448/IAS.20.01.21678 | |
| dc.identifier.uri | https://repositorio.huesped.org.ar/handle/123456789/268 | |
| dc.language | ENG | es_ES |
| dc.provenance | Published | es_ES |
| dc.relation.ispartofseries | Journal of the International AIDS Society;2017 Jan 01;20(1):21678 | |
| dc.rights | openAccess | es_ES |
| dc.subject | HIV-1 | es_ES |
| dc.subject | Therapeutics | es_ES |
| dc.title | Dolutegravir–lamivudine as initial therapy in HIV-1 infected, ARV-naive patients, 48-week results of the PADDLE (Pilot Antiretroviral Design with Dolutegravir LamivudinE) study | es_ES |
| dc.type | Articulo | es_ES |