scholarly journals Efficacy and Safety of Glecaprevir/Pibrentasvir in HCV Patients With Previous Direct-Acting Antiviral Therapy Failures: A Meta-Analysis

2020 ◽  
Vol 7 ◽  
Author(s):  
Chao Shen ◽  
Haozhi Fan ◽  
Zhijun Ge ◽  
Weihua Cai ◽  
Jianguo Shao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Publication Bias ◽  
Sustained Viral Response ◽  
The United States ◽  
Comprehensive Analysis ◽  
Bibliographic Databases ◽  
Efficacy And Safety ◽  
Direct Acting Antiviral ◽  
Number Of Patients ◽  
Direct Acting

Background: Since a greater number of hepatitis C virus (HCV) patients have access to direct-acting antiviral (DAA) based therapies, the number of patients not properly responding to prior DAA regimens is increasing. The objective of this comprehensive analysis was to assess the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in HCV patients who experienced previous DAA therapy failures.Methods: Bibliographic databases were systematically searched for relevant articles published by November 2020. The main endpoints were sustained viral response after 12 weeks (SVR12), adverse events (AEs; any grade) and severe adverse events (SAEs). Publication bias assessment was performed using funnel plots and the Egger's test.Results: Fourteen studies consisting of a total of 1,294 subjects were included in this study and the pooled estimate of SVR12, AEs and SAEs rates were 96.8% (95%CI: 95.1–98.2), 47.1% (95%CI: 26.0–69.3), and 1.8% (95%CI: 0.7–3.4), respectively. Subgroup analysis showed that pooled SVR12 rates were 97.9% (95%CI: 96.7–98.9) for Japan and 91.1% (95%CI: 87.3–94.3) for the United States; 95.8% (95%CI: 93.9–97.4) for genotype (GT)1 and 100.0% (95%CI: 99.6–100.0) for GT2; 95.3% (95%CI: 92.4–97.2) for cirrhosis and 96.3% (95%CI: 94.2–97.7) for non-cirrhosis cases. There was no publication bias included this study.Conclusion: This comprehensive analysis revealed that GLE/PIB is an effective and secure retreatment option for patients who did not optimally respond to DAA treatment, especially the Asian population with GT1-2.

scholarly journals Population impact of direct-acting antiviral treatment on new presentations of hepatitis C-related decompensated cirrhosis: a national record-linkage study

Gut ◽  
2020 ◽  
Vol 69 (12) ◽  
pp. 2223-2231 ◽  
Author(s):  
Sharon J Hutchinson ◽  
Heather Valerio ◽  
Scott A McDonald ◽  
Alan Yeung ◽  
Kevin Pollock ◽  
...  
Keyword(s):  
Antiviral Treatment ◽  
Scale Up ◽  
Sustained Viral Response ◽  
Population Based ◽  
Decompensated Cirrhosis ◽  
Direct Acting Antiviral ◽  
Clinical Databases ◽  
Number Of Patients ◽  
Direct Acting ◽  
The Impact

ObjectivePopulation-based studies demonstrating the clinical impact of interferon-free direct-acting antiviral (DAA) therapies are lacking. We examined the impact of the introduction of DAAs on HCV-related decompensated cirrhosis (DC) through analysis of population-based data from Scotland.DesignThrough analysis of national surveillance data (involving linkage of HCV diagnosis and clinical databases to hospital and deaths registers), we determined i) the scale-up in the number of patients treated and achieving a sustained viral response (SVR), and ii) the change in the trend of new presentations with HCV-related DC, with the introduction of DAAs.ResultsApproximately 11 000 patients had been treated in Scotland over the 8-year period 2010/11 to 2017/18. The scale-up in the number of patients achieving SVR between the pre-DAA and DAA eras was 2.3-fold overall and 5.9-fold among those with compensated cirrhosis (the group at immediate risk of developing DC). In the pre-DAA era, the annual number of HCV-related DC presentations increased 4.6-fold between 2000 (30) and 2014 (142). In the DAA era, presentations decreased by 51% to 69 in 2018 (and by 67% among those with chronic infection at presentation), representing a significant change in trend (rate ratio 0.88, 95% CI 0.85 to 0.90). With the introduction of DAAs, an estimated 330 DC cases had been averted during 2015–18.ConclusionsNational scale-up in interferon-free DAA treatment is associated with the rapid downturn in presentations of HCV-related DC at the population-level. Major progress in averting HCV-related DC in the short-term is feasible, and thus other countries should strive to achieve the same.

scholarly journals Liver Pathologic Changes After Direct-Acting Antiviral Agent Therapy and Sustained Virologic Response in the Setting of Chronic Hepatitis C Virus Infection

2020 ◽  
Author(s):  
Romulo Celli ◽  
Saad Saffo ◽  
Saleem Kamili ◽  
Nicholas Wiese ◽  
Tonya Hayden ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Liver Tissue ◽  
Sustained Viral Response ◽  
Antiviral Agent ◽  
Hcv Infection ◽  
Hcv Rna ◽  
Direct Acting Antiviral ◽  
Viral Hepatitis C ◽  
Number Of Patients ◽  
Direct Acting

Context.— Treatment of chronic viral hepatitis C (HCV) infection with direct-acting antiviral agents (DAAs) results in cure, or sustained viral response (SVR), in more than 90% of patients. However, there are subsets of patients who have persistent liver inflammation and fibrosis and develop hepatocellular carcinoma (HCC) despite achieving SVR. A possible reason for these phenomena may be the presence of virus particles in liver tissue but not blood, otherwise defined as occult infection. Objective.— To describe liver histologic findings following successful DAA therapy, test HCV RNA by (liver) tissue polymerase chain reaction in treated cases, and identify predictive markers for HCC development in treated cases. Design.— A total of 96 identified patients were divided into 4 groups, each differentiated by the presence or absence of SVR and HCC. Groups were compared for several clinicopathologic variables, including degree of inflammation and fibrosis, and the ‘directionality' of fibrosis in cirrhotic livers using the novel progressive-indeterminate-regressive scoring system. Results.— Overall, we found a significant decrease in inflammation in SVR patients. None of the patients showed regression of their cirrhosis following treatment. No evidence of occult HCV infection was seen in 40 livers tested, including 21 with HCC. The number of patients who developed HCC was similar in the SVR and non-SVR groups, and increased inflammation and fibrosis were associated with HCC development. Conclusions.— Following DAA-SVR there appears to be an overall decrease in inflammation, but the fibrosis tends to persist, at least in the short term (median follow-up of 20.2 months).

scholarly journals Direct-Acting Antivirals and Organ Transplantation: Is There Anything We Can’t Do?

2020 ◽  
Vol 222 (Supplement_9) ◽  
pp. S794-S801
Author(s):  
Matthew R Kappus ◽  
Cameron R Wolfe ◽  
Andrew J Muir
Keyword(s):  
Organ Transplantation ◽  
The United States ◽  
Virologic Response ◽  
Hcv Infection ◽  
Solid Organ ◽  
Direct Acting Antiviral ◽  
Transplant Candidates ◽  
Direct Acting ◽  
High Sustained Virologic Response ◽  
Waitlist Mortality

Abstract The opioid epidemic has resulted in an increase in organ donors with hepatitis C virus (HCV) infection in the United States. With the development of direct-acting antiviral regimens that offer high sustained virologic response rates even in the setting of immunosuppression after transplantation, these HCV-viremic organs are now being offered to transplant candidates with or without preexisting HCV infection. Strategies for HCV treatment with HCV-viremic organs have included delayed and preemptive approaches. This review will discuss key studies in the different solid organ transplants, recent reports of adverse events, and ethical and regulatory considerations. The efficacy of current HCV therapies has created this important opportunity to improve survival for patients with end-organ failure through greater access to organ transplantation and decreased waitlist mortality rate.

scholarly journals Absolute Insurer Denial of Direct-Acting Antiviral Therapy for Hepatitis C: A National Specialty Pharmacy Cohort Study

2018 ◽  
Vol 5 (6) ◽  
Author(s):  
Charitha Gowda ◽  
Stephen Lott ◽  
Matthew Grigorian ◽  
Dena M Carbonari ◽  
M Elle Saine ◽  
...  
Keyword(s):  
Cohort Study ◽  
Hepatitis C ◽  
The United States ◽  
Public And Private ◽  
Commercial Insurance ◽  
Direct Acting Antiviral ◽  
Insurance Type ◽  
Specialty Pharmacy ◽  
Direct Acting ◽  
Over Time

Abstract Background Despite the availability of new direct-acting antiviral (DAA) regimens, changes in DAA reimbursement criteria, and a public health focus on hepatitis C virus (HCV) elimination, it remains unclear if public and private insurers have increased access to these therapies over time. We evaluated changes in the incidence of absolute denial of DAA therapy over time and by insurance type. Methods We conducted a prospective cohort study among patients who had a DAA prescription submitted from January 2016 to April 2017 to Diplomat Pharmacy, Inc., which provides HCV pharmacy services across the United States. The main outcome was absolute denial of DAA prescription, defined as lack of fill approval by the insurer. We calculated the incidence of absolute denial, overall and by insurance type (Medicaid, Medicare, commercial), for the 16-month study period and each quarter. Results Among 9025 patients from 45 states prescribed a DAA regimen (4702 covered by Medicaid, 1821 Medicare, 2502 commercial insurance), 3200 (35.5%; 95% confidence interval, 34.5%–36.5%) were absolutely denied treatment. Absolute denial was more common among patients covered by commercial insurance (52.4%) than Medicaid (34.5%, P < .001) or Medicare (14.7%, P < .001). The incidence of absolute denial increased across each quarter of the study period, overall (27.7% in first quarter to 43.8% in last quarter; test for trend, P < .001) and for each insurance type (test for trend, P < .001 for each type). Conclusions Despite the availability of new DAA regimens and changes in restrictions of these therapies, absolute denials of DAA regimens by insurers have remained high and increased over time, regardless of insurance type.

scholarly journals Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials

2018 ◽  
Vol 5 (11) ◽  
Author(s):  
Jason Grebely ◽  
Massimo Puoti ◽  
Heiner Wedemeyer ◽  
Curtis Cooper ◽  
Mark S Sulkowski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hepatitis C ◽  
Treatment Adherence ◽  
Efficacy And Safety ◽  
Substitution Therapy ◽  
Hcv Treatment ◽  
Opioid Substitution Therapy ◽  
Direct Acting Antiviral ◽  
Direct Acting ◽  
Opioid Substitution

Abstract Background We evaluated the impact of opioid substitution therapy (OST) on the completion, adherence, efficacy, and safety of the 3-direct-acting antiviral regimen of ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-dosed with ritonavir, and dasabuvir ± ribavirin among patients infected with hepatitis C virus (HCV) genotype (GT) 1, with or without compensated cirrhosis. Methods Data were pooled from GT1-infected patients enrolled in 12 phase II/III/IIIb clinical trials and categorized by use of OST. Patients with ongoing drug use were excluded. HCV treatment completion, treatment adherence (≥90%), sustained virologic response at post-treatment week 12 (SVR12), and adverse events were assessed. Results Of 4747 patients, 3% (n = 149) received OST. Among patients receiving OST vs those not receiving OST, 82% (n = 122) vs 52% (n = 2409) had GT1a infection; 76% (n = 113) vs 61% (n = 2792) were treatment naïve; and 17% (n = 25) vs 18% (n = 830) had cirrhosis, respectively. The proportion of patients completing HCV treatment did not differ between those receiving and not receiving OST (97% [n = 144] vs 98% [n = 4510], respectively), whereas adherence to treatment was reduced in patients receiving vs those not receiving OST (88% [n = 105] vs 97% [n = 4057], respectively). SVR12 was similar between patients receiving and not receiving OST (94% [n = 140] vs 96% [n = 4405], respectively; P = .273). Treatment was well tolerated. Conclusions Although treatment adherence was lower in patients receiving OST vs those not receiving OST, treatment completion and SVR12 were similar between groups. These data support the use of direct-acting antiviral therapies in patients receiving OST.

scholarly journals Medical Cannabis for the Primary Care Physician

2019 ◽  
Vol 10 ◽  
pp. 215013271988483 ◽  
Author(s):  
Deepika Slawek ◽  
Senthil Raj Meenrajan ◽  
Marika Rose Alois ◽  
Paige Comstock Barker ◽  
Irene Mison Estores ◽  
...  
Keyword(s):  
Primary Care ◽  
Primary Care Physician ◽  
Primary Care Physicians ◽  
The United States ◽  
Care Physician ◽  
Chronic Health Conditions ◽  
Health Conditions ◽  
Efficacy And Safety ◽  
Medical Cannabis ◽  
Number Of Patients

Medical cannabis use is common in the United States and increasingly more socially acceptable. As more patients seek out and acquire medical cannabis, primary care physicians will be faced with a growing number of patients seeking information on the indications, efficacy, and safety of medical cannabis. We present a case of a patient with several chronic health conditions who asks her primary care provider whether she should try medical cannabis. We provide a review of the pharmacology of medical cannabis, the state of evidence regarding the efficacy of medical cannabis, variations in the types of medical cannabis, and safety monitoring considerations for the primary care physician.

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