Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin for Treatment of Hepatitis C Virus Genotype 1: A Systematic Review and Meta-analysis

Ahmed, Hussien; Abushouk, Abdelrahman Ibrahim; Menshawy, Amr; Mohamed, Arwa; Negida, Ahmed; Loutfy, Samah A.; Abdel-Daim, Mohamed M.

doi:10.1007/s40261-017-0565-5

Cited by 26 publications

(17 citation statements)

References 32 publications

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“…With respect to patients on PTV/OBV/r therapy, a stratified analysis of a Japanese clinical study reported that the SVR rate (90.5%) in patients with cirrhosis was lower (96.0%) than in patients without cirrhosis . However, two meta‐analyses found no difference in the SVR rate between patients with and without cirrhosis . In the present study, the SVR rate of patients with cirrhosis on PTV/OBV/r therapy was significantly lower than that of patients without cirrhosis, irrespective of previous DAA‐based treatment.…”

Section: Discussioncontrasting

confidence: 58%

Efficacy of direct‐acting antiviral treatment in patients with compensated liver cirrhosis: A multicenter study

Itokawa

Atsukawa

Tsubota

et al. 2018

Hepatology Research

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Aim Although the development of new direct‐acting antivirals (DAAs) for the treatment of chronic hepatitis C virus (HCV) infection has markedly advanced, the effects of cirrhosis on DAA treatment remain unclear. We aimed to clarify the impact of cirrhosis on DAA treatment of patients infected with HCV. Methods This large‐scale, multicenter, retrospective study consisted of 2130 HCV genotype 1b‐infected patients who were treated with one of the following DAA combination therapies: asunaprevir/daclatasvir (ASV/DCV), ledipasvir/sofosbuvir (LDV/SOF), or paritaprevir/ombitasvir/ritonavir (PTV/OBV/r). Ninety‐two patients (4.3%) previously received DAA‐based treatment. Seven hundred and forty‐five patients (34.9%) had cirrhosis. Results Overall, the sustained virologic response (SVR) rate was 93.0%. The SVR rates in patients who received ASV/DCV, LDV/SOF, or PTV/OBV/r were 90.0%, 96.9%, and 97.6%, respectively. The SVR rate in patients with cirrhosis (89.1%) was significantly lower than that in patients without cirrhosis (95.1%, P = 6.94 × 10–7). In the multivariate analysis for the overall cohort, absence of cirrhosis (P = 1.26 × 10–3), no previous DAA‐based treatment (P = 2.54 × 10–14), low HCV‐RNA levels (P = 1.64 × 10–6), wild‐type non‐structural protein 5A L31/Y93 (P = 7.33 × 10–13), and DAA regimen (LDV/SOF or PTV/OBV/r) (P = 1.92 × 10–14) were independent factors contributing to SVR. Except for patients with DAA‐based treatment history, absence of cirrhosis (P = 2.15 × 10–3; odds ratio, 2.51) was an independent factor contributing to SVR in 2038 DAA‐naïve patients. Conclusion This study suggests that the presence of cirrhosis reduces the SVR rate of DAA treatment, regardless of the type of DAA treatment.

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Section: Discussioncontrasting

confidence: 58%

Efficacy of direct‐acting antiviral treatment in patients with compensated liver cirrhosis: A multicenter study

Itokawa

Atsukawa

Tsubota

et al. 2018

Hepatology Research

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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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“…It is not intended as a direct comparison between individual drugs, but to describe the patients treated and measure the extent to which the recommendations in the introduction protocol were implemented. Cure rates, based on data from 85% of the cohort, were generally as high as expected from either RCTs [17] or recent observational studies [18–23], with some variation between genotypes. Most of the patients were treated with the recommended combinations of the drugs under study, and the initially moderate adherence to the drug recommendations increased over time, with the increasing inclusion of drugs and drug combinations in the introduction protocol.…”

Section: Discussionmentioning

confidence: 53%

Introduction of the second-generation direct-acting antivirals (DAAs) in chronic hepatitis C: a register-based study in Sweden

Frisk

Aggefors

Cars

et al. 2018

Eur J Clin Pharmacol

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PurposeIntroduction of the direct-acting antivirals (DAAs) for treatment of chronic hepatitis C (CHC) infection has been challenging in all health systems. In Sweden, a national protocol for managed introduction was developed. It was optional, but all county councils agreed to implement and follow it. The purpose of this study was to study (a) cure rates among all patients initiated on treatment in 2014–2015, (b) prescribers’ adherence to the drug recommendations and treatment eligibility criteria in the protocol, and (c) introduction rate in the six Swedish healthcare regions.MethodA cross-sectional study where national data from the Prescribed Drug Register and the quality register InfCare Hepatitis defined the study population, and clinical data from the Patient Register and InfCare Hepatitis were used to monitor outcomes. Descriptive statistics were used.ResultsA total of 3447 patients were initiated on treatment during 2014–2015. The overall cure rate, based on data from 85% of the cohort, was 96%, with variation between genotypes. Adherence to drug recommendations increased over time and varied between 43.2 and 94.2%. Adherence to the treatment eligibility criteria was initially 80% and increased to 87% when treatment restrictions were widened. The introduction rate differed initially between the regions and reached stable levels 15–18 months after the launch of the first DAA.ConclusionThe estimated overall cure rate was 96%, with some variations between genotypes. A high level of adherence to the introduction protocol as well as similar introduction rates in the health care regions indicate that the introduction protocol, alongside with other measures taken, contributed considerably to a rapid uptake and equal distribution of DAAs in Sweden.

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Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin for Treatment of Hepatitis C Virus Genotype 1: A Systematic Review and Meta-analysis

Cited by 26 publications

References 32 publications

Efficacy of direct‐acting antiviral treatment in patients with compensated liver cirrhosis: A multicenter study

Efficacy of direct‐acting antiviral treatment in patients with compensated liver cirrhosis: A multicenter study

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

Introduction of the second-generation direct-acting antivirals (DAAs) in chronic hepatitis C: a register-based study in Sweden

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