Effectiveness and safety of ledipasvir/sofosbuvir ± ribavirin in the treatment of HCV infection: The real-world HARVEST study

Flisiak, Robert; Łucejko, Mariusz; Mazur, Włodzimierz; Janczewska, Ewa; Berak, Hanna; Tomasiewicz, Krzysztof; Mozer‐Lisewska, Iwona; Kozielewicz, Dorota; Gietka, Andrzej; Sikorska, Katarzyna; Wawrzynowicz‐Syczewska, Marta; Nowak, Krzysztof; Zarębska-Michaluk, Dorota; Musialik, Joanna; Simon, Krzysztof; Garlicki, Aleksander; Pleśniak, Robert; Baka-Ćwierz, Barbara; Olszok, Iwona; Augustyniak, Krystyna; Stolarz, Wojciech; Białkowska, Jolanta; Badurek, Anna; Piekarska, Anna

doi:10.1016/j.advms.2017.04.004

Cited by 25 publications

(19 citation statements)

References 18 publications

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“…The primary AMBER study provided first European RWE evidence for virologic response in 99% patients treated with OBV/PTV/r±DSV±RBV irrespective of factors recognized previously as negative predictors of efficacy, such as cirrhosis and null‐response to previous interferon‐based therapy . Excellent response rates and safety profile of this and other interferon‐free regimens were then confirmed in other RWE studies . During the interferon era, virologic response, as a rule, was evaluated after 24 weeks following the end of treatment.…”

Section: Discussionmentioning

confidence: 92%

“…12 Excellent response rates and safety profile of this and other interferon-free regimens were then confirmed in other RWE studies. 13,14,19 During the interferon era, vi- Due to results of clinical trials carried out with DAA based, the interferon-free regimen SVR evaluation period was shortened to 12 weeks and finally SVR12 was confirmed as a sufficient measure of therapeutic success also in RWE studies. 26 However due to a different mechanism of action, conclusions from studies on interferonbased therapies must not be translated directly to DAA regimens.…”

Section: Discussionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 92%

Section: Discussionmentioning

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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“…Recently introduced new generation direct acting antivirals (DAA) administered as combined therapy in so‐called interferon‐free regimens became available in Poland from mid 2015 . Initial real‐world experience (RWE) studies carried out within early access programmes supported by pharmaceutical companies confirmed significantly improved efficacy and safety compared to previously available therapeutic options . However, they included limited numbers of patients with very advanced liver disease, and therefore, this population should not be recognized as representative for patients on the waiting lists for treatment.…”

Section: Introductionmentioning

confidence: 99%

Treatment of HCV infection in Poland at the beginning of the interferon‐free era—the EpiTer‐2 study

Flisiak

Zarębska-Michaluk

Janczewska³

et al. 2018

Journal of Viral Hepatitis

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The aim of the EpiTer-2 study was to analyse patient characteristics and their medication for HCV infection in Poland at the beginning of the interferon-free era. Analysis of data of HCV infected patients treated during the initial period of availability of interferon-free regimens in Poland, who started therapy after 1 July 2015 and had available an efficacy evaluation report before 30 June 2017 was undertaken. A total of 2879 patients with chronic hepatitis C were entered, including 46% with liver cirrhosis. The most common was genotype 1b (86.8%). The study population was gender balanced, the majority of patients were overweight or obese and 69% presented comorbidities, with the highest prevalence that for hypertension. More than half of patients were retreated due to failure of previous therapy with pegylated interferon and ribavirin. Almost two-third of patients received current therapy with ombitasvir/paritaprevir/ritonavir±dasabuvir (OPrD) ±ribavirin. Other patients received mostly sofosbuvir-based regimens including combination with ledipasvir and pegylated interferon and ribavirin for genotype 3-infected patients. Efficacy of treatment in the whole study population measured as intent-to-treat analysis was 95%. The most frequent regimen, administered for patients infected with genotype 1b, was 12 weeks of OPrD, resulting in an SVR rate of 98%. At least one adverse event was reported in 38% of patients, and the death rate was 0.8%. In conclusion, data from the EpiTer-2 study confirmed the excellent efficacy and safety profile of the real-world experience with recently introduced therapeutic options for genotype 1 HCV infection, but demonstrated weakness of the current therapeutic programme regarding genotype 3 infections.

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“…Obecnie brakuje przekonujących danych dotyczących wyboru schematu terapeutycznego w tych przypadkach; leki GLE/PIB oraz PTV/OBV/r zgodnie z ChPL nie są zalecane w niewydolności wątroby klasy B oraz są przeciwwskazane dla chorych z niewydolnością wątroby klasy C, natomiast GZR i EBR są przeciwwskazane zarówno w klasie B, jak i C. Wynika to z potencjalnej toksyczności inhibitorów proteazy u chorych z niewyrównaną marskością wątroby. Z praktyki klinicznej wynika, że ryzyko pogorszenia się funkcji wątroby dotyczy zarówno opcji OBV/PTV/r + DSV ± RBV, jak i SOF/ LDV [32][33][34][35]. Zaleca się w tych przypadkach schematy oparte na SOF oraz inhibitorze NS5A, szczególnie skojarzenie SOF/ VEL lub SOF/LDV spośród terapii genotypowo swoistych.…”

Section: Chorzy Z Niewyrównaną Marskością Wątrobyunclassified

“…Pacjenci z marskością oraz po przeszczepieniu wątroby powinni być leczeni SOF/LDV w skojarzeniu z RBV przez 12 tygodni, a jeśli brak możliwości stosowania RBV, to terapia powinna być wydłużona do 24 tygodni. SOF/LDV można stosować u dzieci powyżej 12 roku życia [34,43].…”

Section: Sofosbuwir/ledipaswir (Sof/ldv)unclassified

Recommendations for the treatment of viral hepatitis C in 2019 by Polish Group of Experts for HCV

Halota¹,

Flisiak²,

Juszczyk³

et al. 2019

medicine

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Głównym celem terapii zakażeń HCV jest eliminacja wiremii, co w konsekwencji powoduje zatrzymanie lub regresję zmian chorobowych w wątrobie, blokując progresję do kolejnych następstw historii naturalnej. Redukuje to ponadto ryzyko generowania dalszych zakażeń. Każda osoba zakażona HCV powinna mieć dostęp do terapii lub reterapii lekami przeciwwirusowymi (DAA), dotyczy to również dzieci, które ukończyły 12 rok życia. Rekomendacje przedstawiają zasady diagnozowania i leczenia zakażeń HCV, a wyróżniają takie stany kliniczne, jak nefropatia, koinfekcje HBV i HIV, niewydolność wątroby, oraz pacjentów w okresie okołoprzeszczepowym. W rekomendacjach uwzględniono zarejestrowane leki anty-HCV, mimo iż nie wszystkie są wprowadzone do programów lekowych NFZ. Należy pamiętać o ryzyku interakcji leków DAA z lekami wcześniej przyjmowanymi przez chorego.

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Effectiveness and safety of ledipasvir/sofosbuvir ± ribavirin in the treatment of HCV infection: The real-world HARVEST study

Cited by 25 publications

References 18 publications

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

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

Treatment of HCV infection in Poland at the beginning of the interferon‐free era—the EpiTer‐2 study

Recommendations for the treatment of viral hepatitis C in 2019 by Polish Group of Experts for HCV

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