Advances in Medical Sciences
Volume 62, Issue 2, September 2017, Pages 387–392
Original research article
Effectiveness and safety of ledipasvir/sofosbuvir ± ribavirin in the treatment of HCV infection: The real-world HARVEST study
Robert Flisiaka, , , Mariusz Łucejkoa, Włodzimierz Mazurb, Ewa Janczewskac, Hanna Berakd, Krzysztof Tomasiewicze, Iwona Mozer-Lisewskaf, Dorota Kozielewiczg, Andrzej Gietkah, Katarzyna Sikorskai, Marta Wawrzynowicz-Syczewskaj, Krzysztof Nowakk, Dorota Zarębska-Michalukl, Joanna Musialikm, Krzysztof Simonn, Aleksander Garlickio, Robert Pleśniakp, Barbara Baka-Ćwierzq, Iwona Olszokr, Krystyna Augustyniaks, Wojciech Stolarzt, Jolanta Białkowskau, Anna Badurekv, Anna Piekarskaw
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Abstract
Background
To evaluate the effectiveness and safety of ledipasvir/sofosbuvir (LDV/SOF) ± ribavirin (RBV) regimen in a real-world setting.
Volume 62, Issue 2, September 2017, Pages 387–392
Original research article
Effectiveness and safety of ledipasvir/sofosbuvir ± ribavirin in the treatment of HCV infection: The real-world HARVEST study
Robert Flisiaka, , , Mariusz Łucejkoa, Włodzimierz Mazurb, Ewa Janczewskac, Hanna Berakd, Krzysztof Tomasiewicze, Iwona Mozer-Lisewskaf, Dorota Kozielewiczg, Andrzej Gietkah, Katarzyna Sikorskai, Marta Wawrzynowicz-Syczewskaj, Krzysztof Nowakk, Dorota Zarębska-Michalukl, Joanna Musialikm, Krzysztof Simonn, Aleksander Garlickio, Robert Pleśniakp, Barbara Baka-Ćwierzq, Iwona Olszokr, Krystyna Augustyniaks, Wojciech Stolarzt, Jolanta Białkowskau, Anna Badurekv, Anna Piekarskaw
Download Full Text Article
Abstract
Background
To evaluate the effectiveness and safety of ledipasvir/sofosbuvir (LDV/SOF) ± ribavirin (RBV) regimen in a real-world setting.
Methods
Patients received a fixed-dose combination tablet containing LDV and SOF with or without RBV, for 8, 12 or 24 weeks. Patients were assessed at baseline, end of treatment, and 12 weeks after the end of treatment. The primary effectiveness endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12).
Patients received a fixed-dose combination tablet containing LDV and SOF with or without RBV, for 8, 12 or 24 weeks. Patients were assessed at baseline, end of treatment, and 12 weeks after the end of treatment. The primary effectiveness endpoint was sustained virologic response 12 weeks after the end of treatment (SVR12).
Results
Of the 86 patients, aged 20–80 years, 82.6% were HCV genotype 1b-infected and 50.0% were cirrhotic. More than half (52.3%) had previously followed pegylated interferon-containing (PEG-IFN) treatment regimens, and 38.5% were null-responders. SVR12 was achieved by 94.2% of patients. All non-responders were cirrhotic: two demonstrated virologic breakthrough and the remaining three relapsed. All patients treated with an 8-week regimen achieved SVR12 despite having high viral load at baseline (HCV RNA of >1 million IU/mL in 8/10 patients, including one with a viral load of >6 million IU/mL). Adverse events were generally mild and transient. Most frequently, fatigue (22.1%), headache (15.1%), and arthralgia (7.0%) were observed. Laboratory abnormalities included anemia and hyperbilirubinemia.
Of the 86 patients, aged 20–80 years, 82.6% were HCV genotype 1b-infected and 50.0% were cirrhotic. More than half (52.3%) had previously followed pegylated interferon-containing (PEG-IFN) treatment regimens, and 38.5% were null-responders. SVR12 was achieved by 94.2% of patients. All non-responders were cirrhotic: two demonstrated virologic breakthrough and the remaining three relapsed. All patients treated with an 8-week regimen achieved SVR12 despite having high viral load at baseline (HCV RNA of >1 million IU/mL in 8/10 patients, including one with a viral load of >6 million IU/mL). Adverse events were generally mild and transient. Most frequently, fatigue (22.1%), headache (15.1%), and arthralgia (7.0%) were observed. Laboratory abnormalities included anemia and hyperbilirubinemia.
Conclusions
Treatment with LDV/SOF ± RBV is an effective and safe option for patients with HCV, including those with advanced liver disease or a history of non-response to PEG-IFN-based therapy.
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Treatment with LDV/SOF ± RBV is an effective and safe option for patients with HCV, including those with advanced liver disease or a history of non-response to PEG-IFN-based therapy.
Continue reading...
Full Text Article
Article link provided by Henry E. Chang via Twitter.
I highly suggest you follow Henry E. Chang on Twitter if you are interested in reading full text articles about the treatment and management of hepatitis C.
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