Virologic and immunologic effectiveness of darunavir-based salvage therapy in HIV-1-infected adults in a Brazilian clinical practice setting: results of a multicenter and retrospective cohort study

Ribeiro, Karina Mota; Biscione, Fernando Martín; Westin, Mateus Rodrigues; Machado, Danielle Pessoa; Greco, Dirceu Bartolomeu; Tupinambás, Unaí

doi:10.1016/j.bjid.2013.04.001

Cited by 9 publications

(14 citation statements)

References 33 publications

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“…Beyond these excellent results for DRV/r used in first‐line cART, in the present study DRV/r also showed very good results in PI‐experienced patients, confirming, but with an even higher success rate, data from previous clinical trials . Indeed, by 12 months of DRV/r treatment, the high VS rate observed in PI‐experienced patients (84.3%) was comparable to that observed in other studies evaluating data from clinical practice . The high VS rate found in our analysis can be explained by the fact that, as a consequence of the evaluation of GRT results at baseline, the majority of these patients had viruses susceptible to both DRV/r and the optimized backbone.…”

Section: Discussionsupporting

confidence: 89%

“…As previously observed in two Brazilian studies evaluating the response to DRV/r in clinical practice , we found a negative association between baseline viraemia >100 000 copies/mL and DRV/r response in PI‐experienced patients. Regarding resistance emergence at failure, a low prevalence of acquired resistance to DRV or other drugs in the regimen was also observed in PI‐experienced patients.…”

Section: Discussionsupporting

confidence: 88%

“…Interestingly, although DRV/r was inferior in terms of efficacy to INIs , it showed a lower resistance level at virological failure compared with drugs with a low/intermediate genetic barrier such as raltegravir or efavirenz . Few data on the DRV/r response and resistance profile are available from clinical practice in antiretroviral‐naïve and treatment‐experienced patients . Little information is also available about the impact of pre‐antiretroviral therapy (ART) viraemia in patients treated with DRV/r in the usual clinical setting.…”

Section: Introductionmentioning

confidence: 99%

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Virological response and resistance profile in HIV‐1‐infected patients starting darunavir‐containing regimens

et al. 2016

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

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Virological response and resistance profile in HIV‐1‐infected patients starting darunavir‐containing regimens

et al. 2016

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“…Our data demonstrated the effectiveness of third-line ART in a programme where the predominant subtype was C. Our findings are in line with other studies from the region that demonstrated good virological suppression rates among patients receiving third-line ART [11,12,23]. Findings from studies in resource limited settings have demonstrated that virologic suppression is a realistic endpoint for most treatment-experienced patients who begin a darunavir-based third-line therapy outside the controlled conditions of a randomized trial, at routine care settings [24][25][26]. NC has a very intense program to help prepare patients for thirdline ART which includes a six-week enhanced adherence support program.…”

Section: Plos Onesupporting

confidence: 88%

Zimbabwe’s national third-line antiretroviral therapy program: Cohort description and treatment outcomes

Chimbetete

Shamu²,

Keiser

2020

PLoS ONE

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Background In 2015, Zimbabwe introduced third-line antiretroviral therapy (ART) through four designated treatment centers; three government clinics in Harare and Bulawayo, and Newlands Clinic (NC), operated by a private voluntary organization in Harare. We describe characteristics of patients receiving third line ART and analyzed treatment outcomes in this national programme as of 31 December 2018. Methods We described the population using proportions for categorical variables, and medians and interquartile ranges for continuous variables. Patients from NC, where data were more complete, were followed from the date of starting third-line ART until death, transfer, loss to follow up or 31 December 2018. Results A total of 209 patients had ever received third-line ART: 124 at NC and 85 from the three government clinics. HIV genotype results were available for 89 (72%) patients at NC and fourteen (16.5%) patients in the government clinics. Median duration of third line ART (years) in the government clinics was 2.3 (IQR:0.6-3.4), 1.3 (IQR: 0.7-1.7) and 1 (0.6-1.9). Of the 67 patients who received third line ART in the government clinics for at least six months, 53 (79%) had most recent viral load (VL) < 1000 copies/ml. Data on other treatment outcomes from government clinics were incomplete. From NC: a total of 109 (88%) patients were still in care, 13 (10.5%) had died and 2 (1.5%) were transferred. Median duration of third-line ART was 1.4 years (IQR: 0.6-2.8). Among the 111 NC patients who had received third-line ART for at least 6 months, 83 (75%) had a VL <50 copies/ml and 106 (95.5%) had a VL <1000 copies/ml.

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“…However, few studies have evaluated the long‐term efficacy and safety of regimens including DRV/r in the real life and outside clinical trials [Young et al, ; Benea et al, ; Biscione et al, ; Ribeiro et al, ]. Herein, we assessed the clinical experienced with DRV/r based on efficacy, safety and tolerability parameters in a large cohort of HIV+ patients in Northwest Spain since its approval since 2007 until nowadays.…”

Section: Introductionmentioning

confidence: 99%

Long‐term clinical experience with darunavir (2007–2015) in a large cohort of HIV‐infected patients in Spain

Pernas

Grandal

Tabernilla

et al. 2016

Journal of Medical Virology

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The clinical experience with the protease inhibitor darunavir/ritonavir (DRV/r) was retrospectively evaluated in a cohort of 173 HIV+ patients who initiated antiretroviral treatment including DRV/r (period 2007-2015). The 43.2% had a CD4 nadir ≤100 cells/mm , 64.1% were treatment-experienced, and 36.5% had failed to >3 lines of antiretroviral therapy. Nonetheless, the rate of virological suppression (HIV-RNA <50 copies/ml) in naïve patients was 63%, 66.7%, and 63.6% at 48, 96, and 144 weeks, respectively. The rate of virological suppression in treatment-experienced patients was 62.7%, 78.7%, and 79.1% at 48, 96, and 144 weeks, respectively. No differences were observed according to the immunovirological status neither dosage of DRV/r. Most of them (82.6%) maintained DRV/r treatment. Causes for DRV/r discontinuation were mainly gastrointestinal and cutaneous adverse events (10.5%), switch to simplification treatment strategies (3.5%) and virological failure (1.7%). These findings demonstrate the prolonged efficacy and tolerability of DRV/r even in multi-treated HIV+ patients with an unfavorable immunovirological status. J. Med. Virol. 88:2125-2131, 2016. © 2016 Wiley Periodicals, Inc.

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Virologic and immunologic effectiveness of darunavir-based salvage therapy in HIV-1-infected adults in a Brazilian clinical practice setting: results of a multicenter and retrospective cohort study

Abstract: Virologic suppression is a realistic endpoint for most treatment-experienced patients who begin a darunavir-based therapy outside the controlled conditions of a randomized trial, at routine care settings.

Cited by 9 publications

References 33 publications

Virological response and resistance profile in HIV‐1‐infected patients starting darunavir‐containing regimens

Virological response and resistance profile in HIV‐1‐infected patients starting darunavir‐containing regimens

Zimbabwe’s national third-line antiretroviral therapy program: Cohort description and treatment outcomes

Long‐term clinical experience with darunavir (2007–2015) in a large cohort of HIV‐infected patients in Spain

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