Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naïve and -experienced, virologically-suppressed adults living with HIV-1

Huhn, Gregory; Wilkin, Aimee M.; Mussini, Cristina; Spinner, Christoph D.; Jezorwski, John; Ghazi, Mohsine El; Landuyt, Erika Van; Lathouwers, Erkki; Brown, Kimberley; Baugh, Bryan; Amber,; groups, Emerald study

doi:10.1080/25787489.2020.1844520

Cited by 8 publications

(4 citation statements)

References 54 publications

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“…A previous study demonstrated that transforming TDF into TAF significantly improved the eGFR of patients (34), which further supports the renal safety of TAF. Although previous studies have indicated that the conversion from TDF to TAF can increase blood lipid and TC levels due to the increasing LDL-C, the ratio of TC/high-density lipoprotein remain unaltered (21,35). The present study demonstrated that TAF treatment did not affect blood lipid levels or the degree of hepatic steatosis within 48 weeks.…”

Section: Discussioncontrasting

confidence: 67%

“…Among them, 45 patients were hepatitis B e antigen (HBeAg)-positive. A total of 61 patients (age, 42.13±12.30) were followed up for 24 weeks, of whom 42 were followed up for 48 weeks (age, 43.39±13.41), including35 patients who were tested HBeAg-positive. According to the baseline ALT levels, 61 patients were divided into group A [ALT≤50 U/l; upper limit of normal (ULN).85-1.51 mmol/l, respectively.…”

mentioning

confidence: 99%

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Efficacy and safety of tenofovir alafenamide fumarate in nucleoside analogue treatment-naïve patients with chronic hepatitis B

Chen¹,

Wei

Jin

et al. 2021

Exp Ther Med

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Tenofovir alafenamide fumarate (TAF) is a first-line drug for the antiviral treatment of patients with chronic hepatitis B (CHB) in China. In the present study, the efficacy and renal safety of TAF were evaluated in treatment-naive patients with CHB. Patients with CHB who had not been previously treated with nucleoside analogues (NAs) were recruited before TAF treatment was initiated. Changes in the levels of hepatitis B virus (HBV) DNA, hepatitis B e antigen (HBeAg) and hepatitis B surface antigen (HBsAg) were analyzed at 24 and 48 weeks using immunoassays. In addition, liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) were analyzed using transient elastography, while alanine aminotransferase (ALT), triglyceride (TG), total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) levels, calcium (Ca) and inorganic phosphorus (IP) levels were measured using biochemistry assay. In addition, the estimated glomerular filtration rate (eGFR) was calculated. After 48 weeks, the ALT normalization rate was 95.24% (40/42), the complete virological response (HBV DNA <20 IU/ml) rate was 69.05% (29/42) and the HBeAg seroconversion rate was 8.57% (3/35). The levels of HBV DNA and HBsAg were significantly decreased from the baseline at 5.49±1.95 to 1.26±0.66 log 10 IU/ml and from 3.59±0.81 to 3.32±0.55 log 10 IU/ml after 48 weeks of treatment, respectively. Compared with that in the baseline measurements, LSM at 48 weeks was significantly decreased from 13.00±8.15 to 8.66±4.45 kPa. No significant differences were observed in the TG, TC, LDL-C, CAP, eGFR, Ca and IP measurements. According to the baseline ALT levels, patients were divided into group A [ALT ≤1 x upper limit of normal (ULN); ULN=50 U/l; n=21], group B (1 x ULN < ALT <2 x ULN; n=22) and group C (ALT ≥2 x ULN; n=18). A significant decrease in HBsAg levels was observed in group B (3.63±0.68 vs. 3.53±0.63 log 10 IU/ml) and group C (4.15±0.57 vs. 3.66±0.48 log 10 IU/ml) at 24 weeks compared with the baseline. In conclusion, TAF was found to be effective and safe in NA treatment-naive patients with CHB. Moreover, the higher the ALT levels, the more prominent the curative effect from TAF treatment. Therefore, NA treatment-naive CHB patients could benefit from TAF treatment in real world.

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Section: Discussioncontrasting

confidence: 67%

mentioning

confidence: 99%

Efficacy and safety of tenofovir alafenamide fumarate in nucleoside analogue treatment-naïve patients with chronic hepatitis B

Chen¹,

Wei

Jin

et al. 2021

Exp Ther Med

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“…This study had limited follow-up of participants receiving cobicistat-boosted protease inhibitors; therefore, it is unclear if the impact is the same with cobicistat. In a subgroup analysis at week 96 of the AMBER and EMERALD trials, eGFR cystatin was stable in the darunavir/cobicistat/TAF/FTC arm, and there were no case of subclinical proximal renal tubulopathy [29]. Boosted darunavir remains an important option for treatment experienced PLWH and these data provide support for minimal renal effects, especially when used with TAF.…”

Section: Protease Inhibitorsmentioning

confidence: 79%

Renal adverse drug reactions

Hughes¹

2021

Current Opinion in HIV and AIDS

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Purpose of review Chronic kidney disease (CKD) is common in people living with HIV (PLWH) and is related to a multitude of factors. The aim of this review is to provide an overview of the most recent evidence of renal adverse effects of antiretroviral drugs, predictors of CKD risk and areas for future research. Recent findingsAdvancing age, cardiometabolic risk factors and adverse effects of antiretroviral drugs contribute to the higher prevalence of CKD in PLWH. Genetic factors and baseline clinical CKD risk are strongly correlated to risk of incident CKD, although it is unclear to what extent gene polymorphisms explain renal adverse effects related to tenofovir disoproxil fumarate (TDF). Switching from TDF to tenofovir alafenamide (TAF) in people with baseline renal dysfunction improves renal parameters; however, the long-term safety and benefit of TAF in individuals at low risk of CKD is an area of ongoing research.

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“…8,19,37 Despite these differences in weight gain between genders, a prior study of virologically-suppressed patients previously treated with a boosted PI and switching to DRV/c/FTC/TAF found that other outcomes (such as the proportion of patients experiencing virologic rebound or patient adherence to medication) were similar between males and females. 38 Similar to the assessment of weight and BMI change, the identification of predictors of weight or BMI increase ≥5% in both cohorts was also limited by a small sample size, resulting in the inclusion of a limited number of predicting factors in the models.…”

Section: Weighted N=325mentioning

confidence: 99%

Weight Change and Predictors of Weight Change Among Patients Initiated on Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide or Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Real-World Retrospective Study

Émond

Rossi

Côté-Sergent

et al. 2021

JHEOR

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Background: Recent evidence suggests that integrase strand transfer inhibitors are associated with greater weight gain than protease inhibitors in patients with human immunodeficiency virus (HIV-1). Objectives: To describe demographic and clinical characteristics of insured patients with HIV-1 in the United States initiating darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/FTC/TAF) or bictegravir/FTC/TAF (BIC/FTC/TAF), assess the differences in weight and body mass index (BMI) change between cohorts up to one year after treatment initiation, and identify the predictors of weight gain associated with each treatment. Methods: The Symphony Health, IDV® database (July 17, 2017 – September 30, 2019) was used to identify treatment naïve or virologically suppressed stable switchers who initiated DRV/c/FTC/TAF or BIC/FTC/TAF (index date) on or after July 17, 2018, were ≥18 years of age on the index date, and had ≥12 months of continuous clinical activity pre-index (baseline period). To account for differences in baseline characteristics, inverse-probability of treatment weighting (IPTW) was used. Mean weight and BMI change from pre- to post-index measurements were compared between weighted cohorts at 3, 6, 9, and 12 months post-index using mean differences. Predictors of weight or BMI gain ≥5% were evaluated at last measurement, for each treatment cohort separately. Results: After IPTW, 452 and 497 patients were included in the DRV/c/FTC/TAF and BIC/FTC/TAF cohorts, respectively. Baseline characteristics were generally well-balanced (mean age=~50 years, female: ~30%), except for the type of antiretroviral therapy from which patients switched. Patients initiated on BIC/FTC/TAF experienced greater weight and BMI increases between the pre-index period and each measurement of the post-index period than patients initiated on DRV/c/FTC/TAF, although results were only statistically significant at 9 months post-index (weight: mean difference=2.50 kg, P=0.005; BMI: mean difference=0.66 kg/m2, P=0.027). A common predictor of weight or BMI gain ≥5% among patients in both cohorts was female gender (DRV/c/FTC/TAF: odds ratio [OR]=5.92, P=0.014; BIC/FTC/TAF: OR=2.00, P<0.001). Conclusion: Patients in the BIC/FTC/TAF cohort experienced greater weight and BMI increases than patients in the DRV/c/FTC/TAF cohort, with differences reaching statistical significance at 9 months post-index. Weight gain is an important factor to consider when selecting antiretroviral regimens, since it is associated with long-term health consequences. Future studies with larger sample size and longer follow-up time are warranted.

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Abstract: & on behalf of the AMBER and EMERALD study groups (2021): Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily

Cited by 8 publications

References 54 publications

Efficacy and safety of tenofovir alafenamide fumarate in nucleoside analogue treatment-naïve patients with chronic hepatitis B

Efficacy and safety of tenofovir alafenamide fumarate in nucleoside analogue treatment-naïve patients with chronic hepatitis B

Renal adverse drug reactions

Weight Change and Predictors of Weight Change Among Patients Initiated on Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide or Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Real-World Retrospective Study

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