Durability of Dolutegravir-Based Regimens: A 5-Year Prospective Observational Study

Vito, Andrea De; Ricci, Elena; Sarchi, Eleonora; Chichino, Guido; Bolla, Cesare; Bellacosa, Chiara; Angarano, Gioacchino; Saracino, Annalisa; Calza, Leonardo; Menzaghi, Barbara; Farinazzo, Maddalena; Angioni, Goffredo; Bruno, Giuseppe; Celesia, Benedetto Maurizio; Falasca, Katia; Mastroianni, Antonio; Guadagnino, Giuliana; Vichi, Francesca; Salomoni, E; Martinelli, Canio; Biagio, Antonio Di; Dentone, Chiara; Taramasso, Lucia; Bassetti, Matteo; Cenderello, Giovanni; Molteni, Chiara; Piconi, Stefania; Pellicanò, Giovanni Francesco; Nunnari, Giuseppe; Valsecchi, Laura; Cordier, Laura; Parisini, S.; Rizzardini, Giuliano; Rusconi, Stefano; Conti, Federico; Bandera, Alessandra; Gori, Andrea; Motta, Davide; Puoti, Massimo; Bonfanti, Paolo; Squillace, Nicola; Migliorino, Guglielmo Marco; Maggi, Paolo; Martini, Salvatore; Trizzino, Marcello; Gulminetti, Roberto; Pagnucco, Layla; Socio, Giuseppe Vittorio De; Nofri, Marco; Francisci, Daniela; Cibelli, Donatella; Parruti, Giustino; Madeddu, Giordano; Mameli, M.; Orofino, Giancarlo; Guastavigna, Marta

doi:10.1089/apc.2021.0089

Cited by 21 publications

(16 citation statements)

References 53 publications

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“…This leads to a less effective second-line regimen and more-frequent secondline failures [54,55]. To overcome such challenges in the future, there is a need to scale up access to relatively new antiretrovirals, such as dolutegravir or darunavir/cobicistat, known to be safe and highly effective, and at the same time to have a higher genetic barrier and longevity in comparison with currently used treatments [56][57][58][59].…”

Section: Plos Onementioning

confidence: 99%

Viraemic-time predicts mortality among people living with HIV on second-line antiretroviral treatment in Myanmar: A retrospective cohort study

Mesic

Decroo

Mar³

et al. 2022

PLoS ONE

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Introduction Despite HIV viral load (VL) monitoring being serial, most studies use a cross-sectional design to evaluate the virological status of a cohort. The objective of our study was to use a simplified approach to calculate viraemic-time: the proportion of follow-up time with unsuppressed VL above the limit of detection. We estimated risk factors for higher viraemic-time and whether viraemic-time predicted mortality in a second-line antiretroviral treatment (ART) cohort in Myanmar. Methods We conducted a retrospective cohort analysis of people living with HIV (PLHIV) who received second-line ART for a period >6 months and who had at least two HIV VL test results between 01 January 2014 and 30 April 2018. Fractional logistic regression assessed risk factors for having higher viraemic-time and Cox proportional hazards regression assessed the association between viraemic-time and mortality. Kaplan-Meier curves were plotted to illustrate survival probability for different viraemic-time categories. Results Among 1,352 participants, 815 (60.3%) never experienced viraemia, and 172 (12.7%), 214 (15.8%), and 80 (5.9%) participants were viraemic <20%, 20–49%, and 50–79% of their total follow-up time, respectively. Few (71; 5.3%) participants were ≥80% of their total follow-up time viraemic. The odds for having higher viraemic-time were higher among people with a history of injecting drug use (aOR 2.01, 95% CI 1.30–3.10, p = 0.002), sex workers (aOR 2.10, 95% CI 1.11–4.00, p = 0.02) and patients treated with lopinavir/ritonavir (vs. atazanavir; aOR 1.53, 95% CI 1.12–2.10, p = 0.008). Viraemic-time was strongly associated with mortality hazard among those with 50–79% and ≥80% viraemic-time (aHR 2.92, 95% CI 1.21–7.10, p = 0.02 and aHR 2.71, 95% CI 1.22–6.01, p = 0.01). This association was not observed in those with viraemic-time <50%. Conclusions Key populations were at risk for having a higher viraemic-time on second-line ART. Viraemic-time predicts clinical outcomes. Differentiated services should target subgroups at risk for a higher viraemic-time to control both HIV transmission and mortality.

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Section: Plos Onementioning

confidence: 99%

Viraemic-time predicts mortality among people living with HIV on second-line antiretroviral treatment in Myanmar: A retrospective cohort study

Mesic

Decroo

Mar³

et al. 2022

PLoS ONE

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“…Only PLWH with at least one follow-up visit after enrollment in SCOLTA were considered eligible. The time in which study participants were enrolled depended on the period in which enrolment was opened for each of the study cohorts, which was as follows: LPV/r October 2002–November 2004 [ 28 ]; ATV/r January 2003–May 2008 [ 29 ]; DRV/r May 2006–August 2012 [ 30 ]; DRV/c April 2016–September 2018 [ 31 ]; RPV January 2013–September 2017 [ 8 ]; RAL October 2007–June 2014 [ 32 ]; EVG January 2014–October 2017 [ 33 ]; BIC July 2019, ongoing: DTG July 2014, ongoing [ 20 , 34 ].…”

Section: Methodsmentioning

confidence: 99%

“…Finally, among integrase inhibitors (INSTIs), dolutegravir (DTG) is one of the preferred agents in first-line ART and switch strategies. However, observational data highlighted a certain rate of neurological and psychiatric disorders occurring in the course of treatment [ 14 ], owing to drug discontinuation in the variable frequency of PLWH [ 15 , 16 , 17 , 18 , 19 , 20 ], up to a maximum of 9.9% in a single Dutch study [ 21 ]. For other INSTIs such as raltegravir (RAL) and elvitegravir (EVG), the incidence of CNS toxicity reports seems lower in the literature [ 22 , 23 ].…”

Section: Introductionmentioning

confidence: 99%

Reversibility of Central Nervous System Adverse Events in Course of Art

Taramasso

Orofino

Ricci

et al. 2022

Viruses

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The purpose of this study is to evaluate the frequency of central nervous system adverse events (CNS-AE) on dolutegravir (DTG) and non-DTG containing ART, and their reversibility, in the observational prospective SCOLTA cohort. Factors associated with CNS-AE were estimated using a Cox proportional-hazards model. 4939 people living with HIV (PLWH) were enrolled in DTG (n = 1179) and non-DTG (n = 3760) cohorts. Sixty-six SNC-AE leading to ART discontinuation were reported, 39/1179 (3.3%) in DTG and 27/3760 (0.7%) in non-DTG cohort. PLWH naïve to ART, with higher CD4 + T count and with psychiatric disorders were more likely to develop a CNS-AE. The risk was lower in non-DTG than DTG-cohort (aHR 0.33, 95% CI 0.19–0.55, p < 0.0001). One-year follow-up was available for 63/66 PLWH with CNS-AE. AE resolution was reported in 35/39 and 23/24 cases in DTG and non-DTG cohorts, respectively. The probability of AE reversibility was not different based on ART class, sex, ethnicity, CDC stage, or baseline psychiatric disorder. At the same time, a lower rate of event resolution was found in PLWH older than 50 years (p = 0.017). In conclusion, CNS-AE leading to ART discontinuation was more frequent in DTG than non-DTG treated PLWH. Most CNS-AE resolved after ART switch, similarly in both DTG and non-DTG cohorts.

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Section: Introductionmentioning

confidence: 99%

“…In the last EACS guidelines, INSTIs represent the preferred class for first-line therapy and as an option for optimization in experienced PWH due to their high efficacy, genetic barrier, and tolerability [ 12 , 13 , 17 , 18 , 19 , 20 , 21 , 22 ]. However, in the last few years, the scientific community focused on this class’s possible role in weight gain, particularly dolutegravir (DTG) [ 11 , 21 , 23 , 24 ]. Regarding Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI), only rilpivirine (RPV) and doravirine (DOR) are recommended by EACS guidelines, thanks to their excellent efficacy and safety [ 14 , 25 , 26 , 27 , 28 ].…”

Section: Introductionmentioning

confidence: 99%

Causes of HIV Treatment Interruption during the Last 20 Years: A Multi-Cohort Real-Life Study

Vito

Ricci

Menzaghi

et al. 2023

Viruses

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In the last years, many antiretroviral drugs (ART) have been developed with increased efficacy. Nowadays, the main reasons for treatment switches are adverse events, proactive strategy or simplification. We conducted a retrospective cohort study to investigate the reason for treatment interruption in the last 20 years. We merged data of eight cohorts of the SCOLTA project: lopinavir/r (LPV), atazanavir/r (ATV), darunavir/r or /c (DRV), rilpivirine (RPV), raltegravir (RAL), elvitegravir/c (EVG), dolutegravir (DTG) and bictegravir (BIC). We included 4405 people with HIV (PWH). Overall, 664 (15.1%), 489 (11.1%), and 271 (6.2%) PWH interrupted the treatment in the first, second, and third years after starting a new ART. Looking at the interruption in the first year, the most frequent causes were adverse events (3.8%), loss to follow-up (3.7%), patients’ decisions (2.6%), treatment failure (1.7%), and simplification (1.3%). In the multivariate analysis regarding experienced patients, treatment with LPV, ATV, RPV or EVG/c, having less than 250 CD4 cells/mL, history of intravenous drug use, and HCV positivity were associated with an increased risk of interruption. In naive people, only LPV/r was associated with an increased risk of interruption, while RPV was associated with a lower risk. In conclusion, our data on more than 4400 PWH show that adverse events have represented the most frequent cause of treatment interruptions in the first year of ART (3.84%). Treatment discontinuations were more frequent during the first year of follow-up and decreased thereafter. First-generation PI in both naïve and experienced PWH, and EVG/c, in experienced PWH, were associated with a higher risk of treatment interruptions.

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Durability of Dolutegravir-Based Regimens: A 5-Year Prospective Observational Study

Cited by 21 publications

References 53 publications

Viraemic-time predicts mortality among people living with HIV on second-line antiretroviral treatment in Myanmar: A retrospective cohort study

Viraemic-time predicts mortality among people living with HIV on second-line antiretroviral treatment in Myanmar: A retrospective cohort study

Reversibility of Central Nervous System Adverse Events in Course of Art

Causes of HIV Treatment Interruption during the Last 20 Years: A Multi-Cohort Real-Life Study

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