Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk

Gatell, José M.; Assoumou, Lambert; Moyle, Graeme; Waters, Laura; Johnson, Margaret; Domingo, Peré; Fox, Julie; Martínez, Estebán; Stellbrink, Hans‐Jürgen; Guaraldi, Giovanni; Masía, Mar; Gompels, Mark; Wit, Stéphane De; Florence, Éric; Eßer, Stefan; Raffi, François; Pozniak, Anton

doi:10.1097/qad.0000000000001675

Cited by 74 publications

(58 citation statements)

References 51 publications

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“…Virological suppression was maintained in 92.1% of subjects, and viraemia was suppressed in 95.3% of patients at the last visit. These rates were similar to those reported in virologically suppressed adults enrolled in the European AIDS Treatment Network (NEAT) 022 trial, in which 93.1% of individuals switching from a ritonavir‐boosted PI to a dolutegravir‐based regimen maintained virological suppression at week 48 . Similarly, previous paediatric cohort studies, involving mainly adolescents and youths, reported high rates of sustained virological success among treatment‐experienced paediatric and young adult patients with viral suppression at dolutegravir initiation .…”

Section: Discussionsupporting

confidence: 83%

Similar efficacy and safety of dolutegravir between age groups of HIV‐1‐infected paediatric and young adult patients aged 5 years and older

et al. 2019

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Objectives The aim of the study was to carry out a comparison of the safety and efficacy of dolutegravir‐based regimens among age groups of HIV‐1‐infected paediatric and young adult patients. Patients and methods This retrospective monocentric study included 109 patients infected since childhood who began receiving dolutegravir between January 2014 and December 2017. The patients were divided into three groups according to age at the time of dolutegravir initiation: 5–11, 12–17 and 18–25 years old. The primary endpoint was the proportion of patients achieving a plasma viral load (PVL) < 50 HIV‐1 RNA copies/mL within 3 months of dolutegravir initiation (for patients with detectable viraemia at baseline), and maintaining virological suppression (PVL < 50 copies/mL) until the last follow‐up visit (for all patients). Results Most of the subjects were antiretroviral‐experienced (91.7%) and virologically suppressed at baseline (66.7%, 54.9% and 56.0% in the 5–11, 12–17 and 18–25 year age groups, respectively). Median follow‐up was 24 months (range 6–54 months). Sustained virological success throughout follow‐up was observed in 79.8% of patients, with similar rates among age groups (87.9%, 72.5% and 84.0%, respectively; P = 0.22). With reinforced measures to improve adherence, undetectable PVL was obtained at the last visit in 88.1% of patients, with similar proportions among age groups (93.9%, 84.3% and 88.0%, respectively; P = 0.51). No emergence of resistance mutations was observed in the 22 patients with virological failure. Dolutegravir was well tolerated; only one patient stopped treatment for severe drug‐related side effects. Conclusions The virological efficacy and safety of dolutegravir were similar among the three age groups. Because of its high genetic barrier to resistance, dolutegravir could be especially useful in the paediatric population, in which the risk of poor treatment adherence is high.

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Section: Discussionsupporting

confidence: 83%

Similar efficacy and safety of dolutegravir between age groups of HIV‐1‐infected paediatric and young adult patients aged 5 years and older

et al. 2019

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“…In the SWORD‐1 and SWORD‐2 studies that randomized virally suppressed participants to DTG‐rilpivirine or continuing on current ART, 19% of the former group reported drug‐related AEs compared to 2% in the latter group . Another randomized trial observed AEs in 12.8% of people who switched to DTG versus 7.2% in those who maintained a protease inhibitor regimen .…”

Section: Discussionmentioning

confidence: 99%

Switch to dolutegravir is well tolerated in Thais with HIV infection

et al. 2019

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Introduction Dolutegravir (DTG) is recommended as part of first‐line antiretroviral therapy (ART) for people living with HIV(PLHIV). We sought to determine the rate of adverse events (AEs) and discontinuations among Thais treated during acute HIV infection (AHI) and switched to DTG‐based regimens. Methods Thai participants in the SEARCH010/RV254 cohort who initiated ART during AHI and switched to DTG for at least 48 weeks were prospectively observed and included in the analysis. Rates and characteristics of DTG‐related AEs and discontinuations were described. Results A total of 313 Thai participants were included in the analysis. The median age was 29 years, 96% were male, 64% had a Bachelor's degree or higher and 16% had a body mass index (BMI) <18.5 kg/m2. Participants were on ART for a median of 124 weeks before switching to DTG. The median (IQR) body weight increased from 63 (56 to 70) kg before to 65 (58 to 73) kg (p < 0.0001) after 48 weeks of DTG. Forty‐nine (16%) developed DTG‐related AEs, corresponding to an incidence of 16.6 per 100 person‐years. Neuropsychiatric symptoms were most frequently encountered (n = 25, 8%), followed by laboratory abnormalities (n = 16, 5%). Six (2%) discontinued DTG, corresponding to an incidence of 2.4 per 100 person‐years. All discontinuations were due to increased liver enzymes in the presence of hepatitis C virus coinfection. In the multivariate analysis, incident hepatitis C virus infection was the only risk factor for discontinuing DTG (hazard ratio 59.4, 95% CI 8.5 to 297.9, p < 0.0001). Neither low BMI nor concurrent abacavir therapy was associated with discontinuation. Conclusions DTG was well tolerated with few discontinuations in this cohort of young men. Incident hepatitis C virus infection was a driver of liver‐related AEs leading to discontinuations. In populations at risk, regular testing for hepatitis C virus during ART is recommended to anticipate possible AEs, guide management and improve safety.

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“…Eligible participants were randomly assigned (1:1) to either switch to DTG 50mg/day plus the same two NtRTIs (DTG-I group) or to continue with the same triple therapy regimen including a PI/r for first 48 weeks [14] after which all patients remaining on a PI/r were switched to DTG and followed up to 96 weeks (DTG-D group) . We assigned patients to treatment groups by computer-generated permuted blocks of four and stratified by country.…”

Section: Randomization and Maskingmentioning

confidence: 99%

“…We performed a randomized, non-inferiority, 96 weeks, strategic trial to compare the efficacy, and impact on lipid parameters of immediate switching to DTG (DTG-I group) to that of remaining on a PI/r regimen for first 48 weeks [14] and then a deferred switching to DTG (DTG-D group) in a population with potential high CVD risk.…”

Section: Introductionmentioning

confidence: 99%

Immediate Versus Deferred Switching From a Boosted Protease Inhibitor–based Regimen to a Dolutegravir-based Regimen in Virologically Suppressed Patients With High Cardiovascular Risk or Age ≥50 Years: Final 96-Week Results of the NEAT022 Study

Gatell

Assoumou

Moyle

et al. 2018

Clinical Infectious Diseases

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Switching from a ritonavir-boosted protease inhibitor to a dolutegravir-based regimen for maintenance of HIV viral suppression in patients with high cardiovascular risk

Abstract: Supplemental Digital Content is available in the text

Cited by 74 publications

References 51 publications

Similar efficacy and safety of dolutegravir between age groups of HIV‐1‐infected paediatric and young adult patients aged 5 years and older

Similar efficacy and safety of dolutegravir between age groups of HIV‐1‐infected paediatric and young adult patients aged 5 years and older

Switch to dolutegravir is well tolerated in Thais with HIV infection

Immediate Versus Deferred Switching From a Boosted Protease Inhibitor–based Regimen to a Dolutegravir-based Regimen in Virologically Suppressed Patients With High Cardiovascular Risk or Age ≥50 Years: Final 96-Week Results of the NEAT022 Study

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