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%

“…Five studies reported data on the risk of DAA discontinuation in patients of different ages: it was observed in 0.9% and 1.2% of adults and older patients, respectively (OR 0.76 95%CI 0.17‐2.3.5; P = 0.60) …”

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%

Section: Resultsmentioning

confidence: 99%

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 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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Safety and efficacy of directly‐acting antiviral therapy for chronic hepatitis C virus in elderly people

2021

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Introduction In Italy, the prevalence of hepatitis C virus (HCV) infection is higher in the elderly, although the efficacy and safety of treatment in this population has not been extensively studied. Moreover, little is known about how much pharmacological interaction affects eligibility to treatment and to what extent the treatment affects subsequent outcomes. Methods We retrospectively analyzed the efficacy and safety of directly acting antivirals (DAAs), drug‐to‐drug interactions, and post‐treatment outcomes in 138 patients with HCV aged 70 years or older, who were consecutively treated in our center between 2015 and 2020. Results The mean age was 77 years old (range = 70–95 years old). The Cumulative Illness Rating Scale of pretherapy severity was classified as moderate to severe in 65% of patients. Fifty‐five patients (40%) presented compensated cirrhosis, eight of which were complicated by hepatocellular carcinoma (HCC) and all were cured before treatment. One hundred two patients (74%) were taking two or more drugs (range = 0–5 concomitant drugs registered) and in 29 patients (21%) we found potential drug‐to‐drug interaction. In 11 of those 29 patients (38%), we were forced to change the chronic therapy, when all therapeutic regimens were equal in terms of efficacy and interactions, to avoid potentially serious drug interactions. One serious adverse event occurred in our sample population (i.e., diverticular bleeding due to interaction with direct oral anticoagulants [DOACs]), whereas mild side effects occurred in 37% of patients. The undetectability of HCV RNA at the end of treatment was achieved in 97% of patients, whereas a sustained virological response (SVR) 12 and SVR 24 were obtained in 98% of patients. When comparing pretherapy with post‐therapy data, after a medium follow‐up of 15 months (median = 1 year, minimum = 2 months, and maximum = 4 years), we observed a reduction in the incidence of episodes of liver decompensation in patients with cirrhosis and a slight increase in the incidence of HCC (with 6 recurrent and 5 de novo HCC), diagnosed within 13 months from the end of therapy. In all patients, we found a significant improvement in all ultrasound variables and a significant reduction in the elastographic measurements. No significant differences in outcomes were observed dividing the population into patients aged ≥ 80 and < 80 years old. Conclusions Directly acting antiviral therapy was found to be safe and effective in elderly people, and, despite the large number of concomitant drugs, pharmacological interactions appeared to not affect the adherence to therapy or the incidence of adverse events. Side effects were mostly independent from the type of DAA used and from the burden of comorbidity. In long‐term follow‐up, the benefit of DAA therapy mainly concerned liver pathology and should be strongly advised in patients with cirrhosis. The therapy was found to not affect...

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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

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

Safety and efficacy of directly‐acting antiviral therapy for chronic hepatitis C virus in elderly people

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