The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients

Taki, Shinya; Tamai, Hideyuki; Ida, Yoshiyuki; Shingaki, Naoki; Kawashima, Akira; Shimizu, Ryo; Moribata, Kosaku; Maekita, Takao; Iguchi, Mikitaka; Kato, Jun; Nakao, Taisei; Kitano, Masayuki

doi:10.5009/gnl17048

Cited by 6 publications

(3 citation statements)

References 24 publications

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“…Safety outcomes were reported by 10 studies (1 RCT, 1 SAT and 8 observational studies) . The risk of bias of the included studies is shown in Table and .…”

Section: Resultsmentioning

confidence: 99%

Direct‐acting antivirals for HCV treatment in older patients: A systematic review and meta‐analysis

Villani

Monami

Cosimo

et al. 2019

Journal of Viral Hepatitis

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The advent of highly effective and well‐tolerated direct antiviral antivirals (DAAs) has dramatically changed the landscape of chronic hepatitis C. The effect of DAAs in older adults is difficult to determine since patients aged ≥ 65 years were too few in most clinical trials and data mainly come from observational studies. We performed a systematic review and meta‐analysis to evaluate the efficacy and safety of DAAs in patients aged 65 and older. PubMed, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, HCV‐Trials.com databases were searched for literature published until 1 December 2017. English language articles reporting results of phase 2 or 3 randomized controlled trials (RCTs), single‐arm clinical trials (SATs) and observational studies were included in the final analysis. All studies included subgroups of older patients and compared their outcomes with younger individuals. By using a random‐effects or fixed‐effects model, odds ratio (OR) was calculated for the efficacy and safety. Heterogeneity was tested using I2 statistics. Thirty‐seven studies reported data on the DAA efficacy. The OR was 1.66 (95%CI: 1.00‐2.75; P = 0.06) in meta‐analysis of RCTs, and similar results were found in SATs and observational studies. HCV genotype, stage of fibrosis or HIV co‐infection did not affect the rate of SVR in older persons. Prevalence of anaemia (OR 0.26 95%CI: 0.09‐0.69; P = 0.007) (OR 0.25 95%CI: 0.09‐0.69; P = 0.007) and skin complaints (OR 0.61 95%CI: 0.45‐0.83; P = 0.001) was higher in older adults. Finally, geriatric patients affected by chronic HCV infection can be safely treated with DAAs with the same efficacy reported in younger adults.

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“…Safety outcomes were reported by 10 studies (1 RCT, 1 SAT and 8 observational studies) . The risk of bias of the included studies is shown in Table and .…”

Section: Resultsmentioning

confidence: 99%

Direct‐acting antivirals for HCV treatment in older patients: A systematic review and meta‐analysis

Villani

Monami

Cosimo

et al. 2019

Journal of Viral Hepatitis

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“…Testing for pre‐existing NS5A RASs before this therapy was therefore recommended in the Japanese guidelines to avoid treatment failure where possible . In fact, the SVR rate for this therapy among patients without NS5A RASs and failure of simeprevir‐based triple therapy was extremely high (98%) in our prospective cohort study in a real‐world setting …”

Section: Introductionmentioning

confidence: 84%

Real‐world safety and efficacy of sofosbuvir and ledipasvir for elderly patients

et al. 2018

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Background and AimIn September 2015, sofosbuvir and ledipasvir were approved for clinical use in Japan for patients infected with genotype 1 hepatitis C virus. We conducted a postmarketing prospective cohort study to elucidate the safety and efficacy of this therapy in a real‐world setting.MethodsWe treated 509 patients using standard doses of sofosbuvir and ledipasvir for 12 weeks. As sustained virological response (SVR) in 2 patients could not be evaluated, 507 patients were finally analyzed. Patients with daclatasvir plus asunaprevir failure were excluded.ResultsFour patients (0.8%) discontinued treatment due to adverse events. SVR rates for the overall cohort, patients <65 years old, ≥65 and <75 years old, and ≥75 years old were 98% (495/507), 98% (161/163), 96% (179/186), and 98% (155/158), respectively. SVR rates among cirrhotic patients, patients with moderate chronic kidney disease (CKD), patients with a history of hepatocellular carcinoma (HCC) treatment, patients with protease inhibitor (PI) triple therapy failure, and patients with resistance‐associated substitutions (RASs) to nonstructural protein 5A (NS5A) were 97% (228/235), 98% (117/119), 95% (95/100), 94% (46/49), and 92% (44/48), respectively. In the comparison of factors between patients with and without SVR, high body weight, discontinuation of therapy, and NS5A RASs were significantly associated with non‐SVR.ConclusionsIn this real‐world setting, sofosbuvir and ledipasvir were a safe treatment even in patients ≥75 years old. When patients without pre‐existing NS5A RASs and daclatasvir plus asunaprevir failure are selected, extremely high SVR rates can be achieved irrespective of age.

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“…Ursodeoxycholic acid (UDCA) has long been used empirically as a drug for cholestatic drug-induced liver injury to shorten the time to resolution [ 11 , 12 ]. For daclatasvir/asunaprevir as an NS3 protease inhibitor-containing regimen, Taki et al indicated that the lower frequency of serious drug-induced liver injury compared to previous reports may have been attributable to the use of add-on UDCA [ 13 ]. However, evidence for the efficacy of UDCA for protease inhibitor-induced liver injury remains insufficient.…”

Section: Introductionmentioning

confidence: 99%

Risk Factors of Glecaprevir/Pibrentasvir-Induced Liver Injury and Efficacy of Ursodeoxycholic Acid

Tamai

Okamura

2023

Viruses

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Although glecaprevir/pibrentasvir (GP) therapy is recommended as a first-line treatment for hepatitis C virus (HCV) infection, serious drug-induced liver injury occasionally develops. The present study aimed to elucidate real-world risk factors for GP-induced liver injury and to evaluate the efficacy of add-on ursodeoxycholic acid (UDCA) for liver injury. We analyzed 236 HCV patients who received GP therapy. GP-induced liver injury was defined as any elevation to grade ≥1 in total bilirubin (TB), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or γ-glutamyl transferase (γ-GT) during treatment without other cause. The frequency of GP-induced liver injury was 61.9% (146/236). Serious elevation to grade ≥3 in TB, AST, ALT, ALP, and γ-GT was identified in 3.8% (9/236), 0%, 0%, 0%, and 0.4% (1/209), respectively. Therapy discontinuation and dose reduction were seen in one patient each. Multivariate analysis revealed age and TB as independent risk factors for GP-induced liver injury. In patients with grade ≥2 hyperbilirubinemia, TB after onset significantly decreased in the add-on UDCA group but not in the no UDCA group. Careful attention to GP-induced liver injury is warranted for elderly patients with cirrhosis. Add-on UDCA could suppress the aggravation of GP-induced liver injury.

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The Real-World Safety and Efficacy of Daclatasvir and Asunaprevir for Elderly Patients

Cited by 6 publications

References 24 publications

Direct‐acting antivirals for HCV treatment in older patients: A systematic review and meta‐analysis

Direct‐acting antivirals for HCV treatment in older patients: A systematic review and meta‐analysis

Real‐world safety and efficacy of sofosbuvir and ledipasvir for elderly patients

Risk Factors of Glecaprevir/Pibrentasvir-Induced Liver Injury and Efficacy of Ursodeoxycholic Acid

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