Efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for the treatment of HCV genotype 1b compensated cirrhosis in patients aged 70 years or older

Trifan, Anca; Stanciu, C; Gheorghe, Liana; Iacob, Speranţa; Curescu, Manuela; Prelipcean, Cristina Cijevschi; Ştefănescu, Gabriela; Gîrleanu, Irina; Chiriac, Ştefan; Craiu, Mihai; Brisc, Ciprian; Goldiş, Adrian; Sporea, Ioan; Miftode, Egidia; Bățagă, Simona; Rogoveanu, Ion; Preda, Carmen Monica; Căruntu, Florin Alexandru; Sîngeap, Ana-Maria

doi:10.1097/md.0000000000009271

Cited by 21 publications

(18 citation statements)

References 29 publications

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“…The tolerability profile of IFN-free regimens in the current analysis was in accordance with clinical trials and realworld studies (40)(41)(42)(43)(44)(45). A total of 41% of the entire cohort reported at least one AE, more often in RBV-containing group.…”

Section: Discussionsupporting

confidence: 78%

Interferon Free Therapy with and Without Ribavirin for Genotype 1 HCV Cirrhotic Patients in the Real World Experience

et al. 2018

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Background: In the interferon era, patients with HCV-related cirrhosis were considered hard to treat due to contraindications to therapy, safety issues, and poor response. Objectives: We investigated interferon-free regimens in cirrhotic patients in real-world practice. Methods: We analyzed data of HCV infected patients with liver cirrhosis conducted in 22 Polish hepatology centers. They were assigned to a treatment schedule based on physician decision. Data were collected retrospectively by an online questionnaire. Results: In total, 1113 patients infected with genotype 1 HCV were enrolled to the analysis, 96.6% presented GT1b infection. A total of 56% were treatment-experienced, mostly with PegIFN + RBV, 77.2% of group presented comorbidities with the most frequent hypertension and diabetes,73.2% patients were treated with concomitant medications, and 31% of cohort was assigned to RBV-free regimen, majority of them to OBV/PTV/r + DSV. Overall, 94.7% patients achieved the sustained virological response in intent-to-treat analysis, with comparable rate for RBV-free and RBV-containing options (94.2% vs. 94.9%). Treatment course was more often modified in RBV-containing group, whereas rate of discontinuation was the same for both cohorts. Adverse events were observed in 41% with the most common weakness/fatigue; more frequently in RBV-containing regimens (43% vs. 36.6%). Serious adverse events were reported in 4.1% patients. A total of 16 deaths not related to study drugs were documented, mostly in RBV-containing group. Conclusions: We confirmed effectiveness of the interferon-free regimens without ribavirin in real-world cohort of cirrhotic patients with chronic HCV infection genotype 1. Therapy was well tolerated with infrequent adverse events.

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Section: Discussionsupporting

confidence: 78%

Interferon Free Therapy with and Without Ribavirin for Genotype 1 HCV Cirrhotic Patients in the Real World Experience

et al. 2018

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“…The elderly discontinued interferon (IFN)‐based treatment more frequently due to side effects and achieved lower sustained virologic response (SVR) rates than younger patients 2,5,7–9,12,13 . As a result of comorbid medical conditions and poorer treatment outcomes, older adults were often precluded from interferon‐based HCV treatment 2,5,6,14,15 …”

Section: Introductionmentioning

confidence: 99%

Hepatitis C direct‐acting antiviral outcomes in patients 75 years and older

et al. 2020

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Background and AimElderly patients with hepatitis C virus (HCV) infection have worse interferon‐based treatment outcomes than young patients. Direct‐acting antiviral (DAA) regimens have enabled the treatment of previously difficult‐to‐cure populations. There are few studies that specifically assess DAA treatment outcomes in patients over 75 years of age.MethodsDesign: This was a cohort study. Setting: The setting was three Canadian HCV specialty sites. Participants: Patients aged 75 years and older and treated with DAA without interferon were enrolled. Measurements: Patient demographics, liver fibrosis by transient elastography, treatment regimen, and treatment outcome data were collected.ResultsThe mean age of 78 patients in our analysis was 78.6 years (SD 3.5; range: 75–88 years). The most common genotype was 1b (35%). The most frequently utilized regimens included sofosbuvir‐velpatasvir (33%) and ledipasvir‐sofosbuvir (32%). Ribavirin was included for 17% of recipients. Sustained virological response (SVR) was achieved in 94% of patients (69% of those receiving ribavirin and 98% of patients on ribavirin‐free regimens). Ribavirin toxicity contributed to the lower SVR rates in ribavirin‐exposed patients. Ribavirin dosage was decreased in three patients and ultimately discontinued in two of these patients. All treatment was discontinued in another two patients.ConclusionRibavirin‐free DAA therapy is safe and achieves SVR rates in older adults comparable to those described in the general population. RBV inclusion frequently results in complications, often leads to treatment modification or interruption, and does not improve SVR rates in those with advanced age.

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“…This rate was initially assumed as 5%, slightly increasing each year until 14.9% in 2009 [25], remaining constant until 2016. Since that year, this rate was considered to be close to 27.65% [28], for both genders and all the age groups.…”

Section: Remnant Population and Vertical Transmissionmentioning

confidence: 99%

“…The SVR rate for patients in Tx2 was assumed as 98% for "non-cirrhotic", 99.25% [28] for "compensated cirrhotic" and 0% for "decompensated cirrhotic", values that were considered to be constant for all the years in the period 2017-2030 regardless of the age group.…”

Section: Remnant Population and Vertical Transmissionmentioning

confidence: 99%

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Modeling the Puzzle of Hepatitis C Epidemiology in Romania: A Pathway to Control

Lopes

Baptista‐Leite

Franco

et al. 2020

JGLD

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Background and Aims: To combat hepatitis C virus (HCV) and achieve its elimination by 2030, the emphasis should be on public health policies. In this study, we investigated the dynamics of epidemiology of HCV in Romanian risk groups that are characterized by higher occurrence densities with the aid of The Let’s End HepC (LEHC) project. Methods: The LEHC project addressed the modelling of HCV epidemiology, being applied in several countries, one of which is Romania. The model comprised an integrated solution of public health policies focused on the disease, using Adaptive Conjoint Analysis and Markov chains systems. This tool allowed the quantitative evaluation of public health policies‘ impact, for every year until 2030, in five population groups: people who inject drugs (PWID), prisoners, individuals who have received blood products, children at risk for vertical transmission, and the remnant population. Results: It appears that Romania was already making great efforts in the context of public policies, allowing the achievement of HCV elimination by 2028 if current policies were maintained. Through additional work and greater efforts in further implementing public policies, the LEHC model estimated the possibility of anticipating this outcome to 2026. Conclusion: The LEHC model estimated an anticipation of the HCV elimination year in Romania to be 2026 if the twenty-four health policies in the study are fully implemented and consistently maintained over the years.

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Efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for the treatment of HCV genotype 1b compensated cirrhosis in patients aged 70 years or older

Cited by 21 publications

References 29 publications

Interferon Free Therapy with and Without Ribavirin for Genotype 1 HCV Cirrhotic Patients in the Real World Experience

Interferon Free Therapy with and Without Ribavirin for Genotype 1 HCV Cirrhotic Patients in the Real World Experience

Hepatitis C direct‐acting antiviral outcomes in patients 75 years and older

Modeling the Puzzle of Hepatitis C Epidemiology in Romania: A Pathway to Control

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