Effectiveness and Safety of Sofosbuvir/Ledipasvir Treatment for Monoinfected Genotype 1 HCV Patients in Real-Life Clinical Practice: Results from Spanish Hepa-C Cohort

Crespo, Javier; Fenandez, I.; Cabezas, J.; Albillos, A.; Perelló, Christie; García‐Samaniego, J.; Serra, Monica; Diago, M.; Pascasio, J.M.; Prieto, M.; Llerena, Susana; Mariñó, Zoe; Fernández, C.; Buti, Marı́a; Bañares, Rafael; Simon, Michèle; Turnés, Juan; Sacristan, B.; Jorquera, Francisco; López, Carbajal; Salcines, J.R.; Ampuero, Javier; Sánchez-Ruano, Juan José; Morillas, Rosa; Navascués, C.A.; Vega, Juan de la; Bonet, Lucía; Cuaresma, M.; Andrade, Rodrigues de; Carrion, J.A.; Royuela, F.S.; Iacono, Oreste Lo; Sánchez-Antolín, Gloria; Molina, Esther; Ruíz, José Antonio López; Montoliu, Silvia; Torras, Xavier; Moreno, J.M.; Pobre, Pilar Sánchez; Fernández, José R.; Bermejo, Miguel Fernández; Gea, Francisco; Romero, Míriam; García, David; Manzano, María Luisa; Calleja, J.L.

doi:10.1016/s0168-8278(16)00188-4

Cited by 10 publications

(17 citation statements)

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“…Subsequently, four studies were removed due to potential for overlap (http://onlinelibrary.wiley.com/doi/10.1002/hep.29005/suppinfo). This led to selection of six studies for inclusion, of which one was a published manuscript and the remainder were published abstracts . A total of 5,637 cases were identified, with the study sample size varying from 90 to 1,981 patients.…”

Section: Resultsmentioning

confidence: 99%

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Eight weeks of ledipasvir/sofosbuvir is effective for selected patients with genotype 1 hepatitis C virus infection

et al. 2017

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Section: Resultsmentioning

confidence: 99%

“… Forest plot comparing RR for relapse between 8 weeks' and 12 weeks' duration of LDV/SOF treatment. Studies are as follows: Afdhal et al, Backus et al, Buggisch et al, Crespo et al, Gill et al, and Lai et al…”

Section: Resultsmentioning

confidence: 99%

Eight weeks of ledipasvir/sofosbuvir is effective for selected patients with genotype 1 hepatitis C virus infection

et al. 2017

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“…On the other hand, results from the TRIO database including 895 patients, supported possible shortening of the LDV/SOF regimen to 8 weeks in patients with G1b infection . No difference was found in relation to the length of treatment in 1956 patients in the German Hepatitis‐C Registry or in 423 patients from the Spanish HEPA‐C cohort who qualified for a 8‐week regimen . In the 323 patients from HCV‐Target study who received a shorter regimen, 131 received 8 weeks of LDV/SOF resulting in a 97% SVR rate that was the same as that in patients treated for 12 weeks…”

Section: Ldv/sof±rbv: Sustained Virologic Response Of 91%‐98%mentioning

confidence: 98%

Hepatitis C: efficacy and safety in real life

Flisiak

Pogorzelska

Flisiak-Jackiewicz

2017

Liver International

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Interferon-free combinations were registered in 2014 and 2015 for the treatment of chronic HCV infection. As a result, real-world experience has been gathered in the last year and this paper presents data available in September 2016. Real-world studies on the efficacy of the ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) regimen showed a sustained virologic response (SVR) rate of between 91% and 98%. The SVR rate in the 13858 patients included in this paper was 94%, and 92% in the 3506 patients with cirrhosis. In a number of recently published real-world studies evaluating ombitasvir/paritaprevir/ritonavir (OBV/PTV/r)±dasabuvir (DSV)±RBV, the SVR rate was between 92% and 100%. The SVR rate of the 4260 patients included in the studies in this paper was 97% and the rate was the same in the 1647 patients with cirrhosis. Recently, data evaluating SOF/simeprevir±RBV showed an SVR rate >90%, while in combination with daclatasvir this rate reached approximately 95%. The safety data available for LDV/SOF±RBV and OBV/PTV/r±DSV±RBV show that discontinuation due to adverse events was necessary in no more than 3% of patients and the frequency of serious adverse events was between 0 and 11%, in particular in real-world studies. Because of the similar efficacy and safety, real-world data support the use of either the LDV/SOF±RBV or OBV/PTV/r±DSV±RBV regimen in patients with genotypes 1 or 4. There is still not enough real-world data in patients with genotype 3 and other genotypes.

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“…Studies of real‐world CHC cohorts have previously confirmed the high efficacy of LDV/SOF therapy observed in clinical trials . Moreover, it has also been demonstrated in early stage of fibrosis in treatment‐naïve GT1 patients that there is no additional benefit in extending treatment duration to 12 weeks if the patient has a viral load of <6 million IU/mL…”

Section: Discussionmentioning

confidence: 82%

“…LDV/SOF can be administered for 8 weeks; however, the 8‐week treatment regimen is underused in our setting . Patients treated for 8 weeks have fewer side effects and better adherence to treatment than patients treated for 12 weeks.…”

Section: Discussionmentioning

confidence: 99%

Cost‐effectiveness analysis of ledipasvir/sofosbuvir in patients with chronic hepatitis C: Treatment of patients with absence or mild fibrosis compared to patients with advanced fibrosis

Buti

Domínguez-Hernández

Oyagüez

et al. 2017

Journal of Viral Hepatitis

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To evaluate the cost-effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in treatment-naïve patients with chronic hepatitis C (CHC) genotype 1 (GT1) in the absence or mild fibrosis (F0-F1) versus advanced fibrosis (F2-F4), from the perspective of the Spanish Health System. A Markov model was developed to simulate disease progression, estimating costs and outcomes [life years gained (LYG) and quality-adjusted life years (QALY)] derived from starting with LDV/SOF in patients with F0-F1 compared with F2-F4. Therapy duration was 8 weeks in noncirrhotic patients with viral load <6 million IU/mL and 12 weeks in the remaining patients. Sustained virologic response rates were obtained from real-world cohort studies. Transition probabilities, utilities and direct costs were obtained from the literature. A 3% annual discount rate was applied to costs and outcomes. Sensitivity analyses were performed. LDV/SOF in F0-F1 patients was a dominant strategy, being more effective (19.85 LYG and 19.80 QALY) than beginning treatment in F2-F4 patients (18.63 LYG and 16.25 QALY), generating savings of €9228 per patient (€3661 due to disease management and monitoring). In a cohort of 1000 patients, LDV/SOF in F0-F1 patients decreased the number of cases of decompensated cirrhosis (93%), hepatocellular carcinoma (97%) and liver-related deaths (95%) and prevented 6 liver transplants compared to initiating LDV/SOF in F2-F4 patients. In CHC treatment-naïve GT1 patients, starting treatment with LDV/SOF in patients with F0-F1 compared to those with F2-F4 increases effectiveness by 1.22 LYG and 3.55 QALY gained and reduces disease burden and it is associated with cost savings.

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Effectiveness and Safety of Sofosbuvir/Ledipasvir Treatment for Monoinfected Genotype 1 HCV Patients in Real-Life Clinical Practice: Results from Spanish Hepa-C Cohort

Cited by 10 publications

References 0 publications

Eight weeks of ledipasvir/sofosbuvir is effective for selected patients with genotype 1 hepatitis C virus infection

Eight weeks of ledipasvir/sofosbuvir is effective for selected patients with genotype 1 hepatitis C virus infection

Hepatitis C: efficacy and safety in real life

Cost‐effectiveness analysis of ledipasvir/sofosbuvir in patients with chronic hepatitis C: Treatment of patients with absence or mild fibrosis compared to patients with advanced fibrosis

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