Ombitasvir/paritaprevir/ritonavir plus dasabuvir combination in the treatment of chronic HCV infection

Łucejko, Mariusz; Parfieniuk‐Kowerda, Anna; Flisiak, Robert

doi:10.1080/14656566.2016.1176143

Cited by 15 publications

(20 citation statements)

References 40 publications

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“…The regimen also proved highly effective in difficult‐to‐treat populations, such as those with liver cirrhosis or null‐responders to previous anti‐viral therapies. SVR12 was achieved in 98.3% (117/119) of patients with liver cirrhosis irrespective of their treatment history, in agreement with the results of previous clinical trials and real‐world studies on patients with cirrhosis (85.9–100%) . The SVR12 rate in nonresponders to previous therapies reached 98.7% (148/150) similar to that observed in pre‐registration trials (92–100%) .…”

Section: Discussionsupporting

confidence: 87%

“…SVR12 was achieved in 98.3% (117/119) of patients with liver cirrhosis irrespective of their treatment history, in agreement with the results of previous clinical trials and real‐world studies on patients with cirrhosis (85.9–100%) . The SVR12 rate in nonresponders to previous therapies reached 98.7% (148/150) similar to that observed in pre‐registration trials (92–100%) . SVR12 was achieved in 97.6% (82/84) of null‐responders to prior PEG‐IFN + RBV therapy, irrespective of the presence of cirrhosis, confirming the rates (85.9–100%) of prior registration studies in patients without cirrhosis or with compensated cirrhosis .…”

Section: Discussionsupporting

confidence: 86%

“…Integrating DAA with different mechanisms of action ensured better virologic response and provided a robust genetic barrier to the emergence of drug‐resistant HCV variants. The combination of the NS5A inhibitor ombitasvir (OBV), the NS3/4A PI paritaprevir (PTV) boosted with ritonavir (r) and the NS5B polymerase inhibitor dasabuvir (DSV), with or without RBV, was the first all oral interferon‐free regimen containing three distinct DAAs approved for therapy of patients infected with HCV genotype 1 and 4, who are both treatment‐naïve and treatment‐experienced . Although the combination proved effective and well tolerated, these were all clinical trials with stringent inclusion criteria and treatment conditions that are substantially different from those observed in normal medical practice.…”

Section: Introductionsupporting

confidence: 90%

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Real‐world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study

Flisiak¹,

Janczewska²,

Wawrzynowicz‐Syczewska³

et al. 2016

Aliment Pharmacol Ther

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Summary Background Virologic and safety outcomes of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) therapy have shown high sustained virologic response (SVR) rates and good tolerability in most patient populations in pre‐registration studies. Aim To confirm these clinical trial findings in the treatment of genotype 1 and 4 hepatitis C under real‐world conditions. Methods Patients enrolled for treatment with OBV/PTV/r ± DSV ± RBV based on therapeutic guidelines were included, and the regimen was administered according to product characteristics. Clinical and laboratory data, including virologic response, were collected at baseline, end of treatment (EOT) and 12 weeks after EOT. Results A total of 209 patients with chronic hepatitis C were enrolled, most were genotype 1b‐infected (84.2%) and 119 (56.9%) had liver cirrhosis. Among these, 150 (71.7%) had failed previous anti‐viral therapies and 84 (40.2%) were null‐responders. At 12 weeks after EOT, SVR was achieved by 207 (99.0%) patients, ranging from 96.4% to 100.0% across subgroups. All Child–Pugh B and post‐orthotopic liver transplantation patients achieved SVR. Adverse events occurred in 151 (72.2%) patients and were mostly mild and associated with the use of RBV. Serious adverse events, including hepatic decompensation, renal insufficiency, anaemia, hepatotoxicity and diarrhoea, were reported in eight (3.8%) patients. In five (2.4%) patients, adverse events led to treatment discontinuation. On‐treatment decompensation was experienced by seven (3.3%) patients. Conclusions The results of our study confirm previous findings. They demonstrate excellent effectiveness and a good safety profile of OBV/PTV/r± DSV±RBV in HCV genotype 1‐infected patients treated in the real‐world setting.

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Section: Discussionsupporting

confidence: 87%

Section: Discussionsupporting

confidence: 86%

Section: Introductionsupporting

confidence: 90%

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Real‐world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study

Flisiak¹,

Janczewska²,

Wawrzynowicz‐Syczewska³

et al. 2016

Aliment Pharmacol Ther

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“…Combination of 2‐3 DAA provided a high genetic barrier to prevent resistance‐associated substitutions in the HCV genome. One of the first available all oral interferon‐free regimens consisted of the NS5A inhibitor ombitasvir (OBV), the NS3/4A protease inhibitor paritaprevir (PTV) boosted with ritonavir (r) and the NS5B polymerase inhibitor dasabuvir (DSV), with or without RBV . OBV/PTV/r±DSV±RBV was approved for therapy of both treatment‐naïve and treatment‐experienced patients infected with HCV genotype 1 and 4 by the end of 2014 …”

Section: Introductionmentioning

confidence: 99%

“…One of the first available all oral interferonfree regimens consisted of the NS5A inhibitor ombitasvir (OBV), the NS3/4A protease inhibitor paritaprevir (PTV) boosted with ritonavir (r) and the NS5B polymerase inhibitor dasabuvir (DSV), with or without RBV. [8][9][10] OBV/PTV/r±DSV±RBV was approved for therapy of both treatment-naïve and treatment-experienced patients infected with HCV genotype 1 and 4 by the end of 2014. 11 As there were no data outside of the clinical trials, the AMBER multicentre, open-label, investigator-initiated study was conducted in 2014-2015 to investigate the effectiveness and safety of OBV/ PTV/r±DSV±RBV in a real-world setting.…”

Section: Introductionmentioning

confidence: 99%

Durability of virologic response, risk of de novo hepatocellular carcinoma, liver function and stiffness 2 years after treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in the AMBER, real‐world experience study

Flisiak

Janczewska

Łucejko

et al. 2018

Journal of Viral Hepatitis

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We followed for 2 years patients treated with direct-acting agents (DAA) to assess long-term durability of virologic response, improvement of liver function, reduction in liver stiffness (LS) and risk of hepatocellular carcinoma (HCC). The study included patients from 16 hepatologic centres involved in the AMBER, investigator-initiated study on treatment of chronic hepatitis C patients within a programme preceding EU registration of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin. A total of 204 patients among 209 from the primary study were enrolled, 200 with available testing at 2-year follow-up (2yFU) with undetectable HCV RNA (198 responders and 2 nonresponders retreated). During 2yFU, 4 patients died, 17 had hepatic decompensation and 3 needed liver transplantation. De novo hepatocellular carcinoma was diagnosed in 4 and its recurrence in 3 patients. Significant decreases in bilirubin, MELD, Child-Pugh scores and liver stiffness, and increases in albumin level were observed during 2yFU. Strengths of the study were a fixed period of post-treatment follow-up, prospective character of the study and high proportion of available patients from the primary study. The major weaknesses were lack of a comparative arm and relatively insufficient number of patients for subsets analysis. In conclusion, 2-year follow-up confirmed durability of virologic response after treatment of HCV infection with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin. It was accompanied by significant improvement of major measures of hepatic function and reduction of hepatic stiffness. Successful therapy did not prevent hepatic decompensation, HCC or death in cirrhotics that support the need for longer than 2-year monitoring for possible disease progression.

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High success rates for the use of ombitasvir/paritaprevir/ritonavir containing regimens in treatment of naïve and experienced chronic hepatitis C genotype 4: Real world results

Kassas

Alboraie

Omar

et al. 2019

Journal of Medical Virology

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Introduction and Aims: Treatment of hepatitis C virus (HCV) genotype 4 patient with fixed dose combination of ombitasvir-paritaprevir-ritonavir plus ribavirin (OBV/rPTV/RBV) has been proven efficacy and safety in many clinical trials. The current study reports the efficacy and safety of OBV/rPTV/RBV (for treatmentnaïve), and OBV/rPTV/RBV/sofosbuvir (SOF) (for treatment-experienced), in chronic HCV genotype 4 patients in real life settings.Methods: Prospective cohort study including all adult chronic HCV genotype 4 patients who were scheduled to receive OBV/rPTV/RBV ± SOF for 12 or 24 weeks in New Cairo Viral Hepatitis Treatment Center. The primary efficacy endpoint was a virologic response at posttreatment week 12 (SVR12). Changes in hematological parameters, liver biochemical profile and fibrosis-4 index (FIB-4), as well as clinical and laboratory adverse events (AEs) across follow up visits (week 4, end of treatment [EOT], and SVR12), were recorded.Results: Our study included 325 patients (age; 47.63 ± 12.63 years, 55.38% [n = 180] men). Most of the included patients (89.85%, n = 292) were treatment naïve and only 7% (n = 23) had liver cirrhosis. Overall, SVR12 was attained by 98.44% (316 of 321) of the patients; 97.15% (307 of 316) of patients who received 12 weeks of OBV/rPTV/ RBV ± SOF and 100% (9 of 9) of patients who received 24 weeks of OBV/rPTV/RBV as assessed by modified intention to treat analysis. There was a significant improvement of baseline alanine aminotransferase, aspartate aminotransferase, hemoglobin, FIB-4 at SVR12 (P < 0.05). The most common reported AEs were anemia (n = 106), fatigue (n = 41) and elevated indirect bilirubin (n = 37). Conclusion:OBV/rPTV/RBV (±SOF) is a highly effective therapy for chronic HCV patients in real life settings.

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Ombitasvir/paritaprevir/ritonavir plus dasabuvir combination in the treatment of chronic HCV infection

Cited by 15 publications

References 40 publications

Real‐world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study

Real‐world effectiveness and safety of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C: AMBER study

Durability of virologic response, risk of de novo hepatocellular carcinoma, liver function and stiffness 2 years after treatment with ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin in the AMBER, real‐world experience study

High success rates for the use of ombitasvir/paritaprevir/ritonavir containing regimens in treatment of naïve and experienced chronic hepatitis C genotype 4: Real world results

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