Clinical efficacy and tolerability of direct-acting antivirals in elderly patients with chronic hepatitis C

Sherigar, Jagannath; Gayam, Vijay; Khan, Arifa; Mukhtar, Osama; Arefiev, Yavgeniy; Khalid, Mazin; Siddiqui, Imran; rangaraju, Ayyappa Mysore; Budhathoki, Nibash; Mansour, Mohammed; Guss, Debra; Mohanty, Smruti R.

doi:10.1097/meg.0000000000000871

Cited by 21 publications

(23 citation statements)

References 31 publications

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“…Seven studies reported data on the prevalence of skin complaints in different age subgroups and reported a slight increase in the frequency of pruritus, rash and photosensitivity in patients aged ≥ 65 years (7% vs 9.9%; OR 0.61 95%CI: 0.45‐0.83; P = 0.001) . To verify the impact of protease inhibitors in the prevalence of skin complaints in older adults, a subgroup analysis only including patients without protease inhibitors in the antiviral regimen was performed and we did not observe any significant difference (OR 0.62 95%CI: 0.31‐1.26; P = 0.19).…”

Section: Resultsmentioning

confidence: 73%

“…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%

“…Three observational studies reported on the prevalence of gastrointestinal side effects (nausea, abdominal pain, vomiting, diarrhoea, constipation, ischaemic colitis and haemorrhagic gastric ulcer) and showed no difference in the age subgroups (2.8% in adults versus 2.3% in older people) …”

Section: Resultsmentioning

confidence: 99%

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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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Section: Resultsmentioning

confidence: 73%

“…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%

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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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“…Multiple prospective and retrospective real‐world studies assessed the treatment efficacy of DAAs in the older age group in different countries . Most of these studies are limited by a small sample, except two studies by Su et al 26 and Lens et al 35 In the retrospective analysis from the Veteran Affairs (VA) healthcare system by Su et al, DAA regimens reported high overall SVR12 rates of 91% to 93.8% in different age subgroups of patients older than 65 years.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Direct‐Acting Antivirals for Chronic Hepatitis C in a Large Cohort of Older Adults in the United States

Pan

Gayam

Rabinovich³

et al. 2019

J American Geriatrics Society

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OBJECTIVES: Data on the virologic response and tolerability of direct-acting antivirals (DAAs) are lacking in older people because these individuals are underrepresented in clinical trials. This study aimed to assess the effectiveness and tolerability of DAA regimens in older individuals in a large cohort of real-life clinical practice. METHODS: In this retrospective study, patients with chronic hepatitis C infection between 2017 and 2018 were divided into patients aged 65 years and older and those younger than 65 years. We evaluated the sustained virologic response rates (SVRs) in both groups. Further subgroup analyses on the SVRs for patients aged 65 to 74, 75 to 84, and 85 years and older were performed. We also analyzed the predictors of treatment response in older individuals. RESULTS: Among 1151 eligible patients, 516 were in the older group and 635 were in the younger group. The overall treatment response in the entire cohort was 97.7%. A significantly higher percentage of patients presented with advanced stages of fibrosis in the older group (53.1% vs 39.5%; P = <.001). The SVR rates were similar between the two groups (98.3% vs 97.7%; P = .18). In multivariate models, age was not predictive of SVR after adjusting for confounders. Subgroup analyses in the age groups of 65 to 74, 75 to 84, and older than 85 years showed similar treatment response rates (97.4%, 97.2%, and 86.7, respectively; P = .06) and advanced fibrosis (50.8%, 61.5%, and 53.3%, respectively; P = .14). CONCLUSION: Although older people exhibit a significantly higher frequency of fibrosis, DAAs produce high rates of SVR in all age groups, and the age of the patient does not seem to have a significant impact on the efficacy of DAAs including patients in the oldest age category (≥75 y). Treatment should not be withheld in older individuals. J Am Geriatr Soc 68:379-387, 2020.

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“…The treatment of HCV has shifted toward more tolerable, safer oral regimens with the use of direct-acting antiviral agents (DAAs). These regimens have truly revolutionized the efficiency of HCV treatment by achieving a sustained virologic response (SVR), shortening the duration of treatment, and improving patient outcomes without the burden of neuropsychiatric adverse effects [11,[16][17][18][19][20][21][22].…”

Section: Introductionmentioning

confidence: 99%

Outcomes of Direct-Acting Antiviral Treatment of Psychiatric Patients with Comorbid Hepatitis C Virus Infection

Gayam

Jegede

Tiongson

et al. 2019

Dig Dis

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Background: The highest burden of hepatitis C virus (HCV) infection is seen in patients with psychiatric disorders who have been excluded from traditional treatments with Interferon due to treatment-emergent neuropsychiatric adverse effects. The goal of this study is to determine the tolerability, treatment retention, and efficacy of direct-acting antivirals with psychiatric disorders and comorbid substance use disorders in real-life settings. Methods: This is a retrospective cohort observational study of HCV patients treated with direct-acting antivirals between January 2016 and December 2018. Patients were stratified and sub-stratified based on their psychiatric diagnosis and substance use. The primary assessment was the sustained virologic response at 12 weeks post-treatment (SVR12). Results: Among the 291 patients analyzed, patients with psychiatric diagnosis and non-psychiatric patients made up 51.2% (n = 149) and 48.8% (n = 142) respectively. Majority of the patients included in the study were African-Americans (68.7%, n = 200). Overall, 95.3% (142/149) and 94.4% (134/142) of psychiatric and nonpsychiatric patients, respectively, achieved SVR12 and treatment response was similar between the groups (p = 0.72). Among psychiatric patients, only the prior treatment status was identified as a predictor of treatment response (OR 0.153, 95% CI 0.03-0.79; p = 0.05). No statistical difference was observed among the patients with SVR12 based on their primary psychiatric diagnoses or by comorbid substance abuse. Conclusion: The results of our study show that directacting antiviral treatments are well tolerated in psychiatric patients, and an overwhelming majority of patients achieved SVR12. Our study highlights the need to integrate HCV screening with treatment linkage in psychiatry and primary care practice.

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Clinical efficacy and tolerability of direct-acting antivirals in elderly patients with chronic hepatitis C

Cited by 21 publications

References 31 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

Efficacy of Direct‐Acting Antivirals for Chronic Hepatitis C in a Large Cohort of Older Adults in the United States

Outcomes of Direct-Acting Antiviral Treatment of Psychiatric Patients with Comorbid Hepatitis C Virus Infection

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