Effectiveness and safety of ledipasvir/sofosbuvir±ribavirin in the treatment of HCV infection: The real-world HARVEST study
| Autor: | Iwona Mozer-Lisewska, Ewa Janczewska, Robert Pleśniak, Jolanta Białkowska, Marta Wawrzynowicz-Syczewska, Dorota Zarębska-Michaluk, Katarzyna Sikorska, Krzysztof Nowak, Mariusz Łucejko, Barbara Baka-Ćwierz, Iwona Olszok, Hanna Berak, Krzysztof Simon, Krystyna Augustyniak, Anna Piekarska, Robert Flisiak, Joanna Musialik, Dorota Kozielewicz, Aleksander Garlicki, Andrzej Gietka, Krzysztof Tomasiewicz, Anna Badurek, Wojciech Stolarz, Włodzimierz Mazur |
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| Rok vydání: | 2017 |
| Předmět: |
Ledipasvir
Adult Male medicine.medical_specialty Sofosbuvir Anemia Hepacivirus Gastroenterology Antiviral Agents 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Internal medicine Ribavirin Medicine Humans 030212 general & internal medicine Adverse effect Aged Aged 80 and over Fluorenes business.industry General Medicine Hepatitis C Middle Aged medicine.disease Virology Regimen Treatment Outcome chemistry 030211 gastroenterology & hepatology Benzimidazoles Drug Therapy Combination Female Safety business Viral load medicine.drug Follow-Up Studies |
| Zdroj: | Advances in medical sciences. 62(2) |
| ISSN: | 1898-4002 |
| Popis: | 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). 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. 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. |
| Databáze: | OpenAIRE |
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