Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study

Welzel, Tania M.; Nelson, David R.; Morelli, Giuseppe; Bisceglie, Adrian Di; Reddy, Rajender; Kuo, Alexander; Lim, Joseph K.; Darling, Jama M.; Pockros, Paul J.; Galati, Joseph; Frazier, Lynn M.; Alqahtani, Saleh A.; Sulkowski, Mark S.; Vainorius, Monika; Akushevich, Lucy; Fried, Michael; Zeuzem, Stefan

doi:10.1136/gutjnl-2016-311609

Cited by 76 publications

(107 citation statements)

References 29 publications

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“…High rates of SVR with the combination SOF + RBV were more similar to those described in Asian CTs[23] than the SVR of 79.0% or 86.2% achieved in clinical practice in the two VA studies[14,18] or the SVR of 88.2% from the recent analysis of 321 genotype 2 HCV infected HCV-TARGET participants[24]. However, the low number of genotype 2 patients in our study indicate that several of the currently recommended combinations in clinical guidelines, such as SOF and DCV[25] should be favored because they presented 100% SVR rates in all patients.…”

Section: Discussionsupporting

confidence: 54%

Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Ramos

Linares

Badía

et al. 2017

WJGPT

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AIMTo investigated the real-world effectiveness and safety of various regimens of interferon-free treatments in patients infected with hepatitis C virus (HCV).METHODSWe performed an observational study to analyze different antiviral treatments administered to 462 HCV-infected patients, of which 56.7% had liver cirrhosis. HCV RNA after 4 wk of treatment and at 12 wk after treatment sustained virologic response (SVR) as well as serious adverse events (SAEs) was analyzed first for the whole cohort and then separately in patients who met or did not meet the inclusion criteria of a clinical trial (CT-met and CT-unmet, respectively).RESULTSThe most frequently prescribed treatment was simeprevir/sofosbuvir (36.4%), followed by sofosbuvir/ledipasvir (24.9%) and ombitasvir/paritaprevir/ritonavir (r)/dasabuvir (19.9%). Ribavirin (RBV) was administered in 198 patients (42.9%). SVRs occurred in 437/462 patients (94.6%). The SVRs ranged between 93.3% and 100% for genotypes 1-4. SVRs were achieved in 96.2% patients in the CT-met group vs 91.9% patients in the CT-unmet group (P = 0.049). Undetectable HCV RNA at week 4 occurred in 72.9% of the patients. In the univariate analysis, the factors associated with SVRs were lower liver stiffness, absence of cirrhosis, higher platelet count, higher albumin levels, no RBV dose reduction, undetectable HCV RNA at week 4 and CT-met group. In the multivariate analysis, only albumin was an independent predictor of treatment failure (P = 0.04). Eleven patients (2.4%) developed SAEs; 5.2% and 0.7% of the patients in the CT-unmet and CT-met groups, respectively (P = 0.003).CONCLUSIONA high proportion of patients with HCV infection achieved SVRs. For patients who did not meet the CT criteria, treatment regimens must be optimized.

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Section: Discussionsupporting

confidence: 54%

Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Ramos

Linares

Badía

et al. 2017

WJGPT

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“…However, drug discontinuation occurred in 2.5 % (G2) and 3.2 % (G3) of patients. Death occurred in 5 patients (1 %) unrelated to the study drugs [98]. However, a recent analysis is a cause for concern with 13 of 42 patients with post transplant rHCV infection developing serious adverse event or hepatic decompensation following regimens containing sofosbuvir and ribavirin.…”

Section: Adverse Events Of Daasmentioning

confidence: 90%

Management of post liver transplantation recurrent hepatitis C infection with directly acting antiviral drugs: a review

2016

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Recurrent HCV infection (rHCV) of the liver allograft following transplantation is universal and is associated with poor graft and patient survival in comparison with other indications. Treatment of rHCV infection in the previous era with pegylated interferon and ribavirin was associated with low sustained virological response (SVR) due to poor tolerability, adverse events and graft rejection. Recently, directly acting antiviral drugs (DAA) have been approved for the treatment of hepatitis C infection and a number of clinical trials have been conducted across various centers in the management of rHCV infection of the graft. In this review we discuss about recent studies that have emerged on the use of NS5b polymerase inhibitor, sofosbuvir in combination with second generation protease inhibitor, simeprevir, fixed dose ledipasvir or daclatasvir with or without ribavirin in the treatment of post transplant rHCV infection.

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“…All patients with HCV RNA <45 IU/ml according to CAP/CTM or <60 IU/ml according to the ART assay achieved SVR, while patients with a week 2 HCV RNA above the respective cut-offs achieved SVR in 33% and 29% only [40] (Table 3). SOF/RBV is widely considered as standard of care in genotype 2 patients and high SVR rates exceeding 88% have been reported [35,95]. As a result, on-treatment HCV RNA was not predictive of SVR in genotype 2 patients treated with SOF/ RBV for 12 weeks in the VALENCE study [94].…”

Section: Key Pointmentioning

confidence: 90%

Diagnostics in hepatitis C: The end of response-guided therapy?

Maasoumy

Vermehren

2016

Journal of Hepatology

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On-treatment hepatitis C virus (HCV) RNA has been used to predict response to interferon (IFN)-based therapy. The concept of response-guided treatment (RGT) was established to determine optimal treatment duration and to early identify patients not responding to futile therapies. RGT helped to improve sustained virologic response (SVR) rates and lower the rates of adverse effects. RGT was of particular importance for telaprevir- and boceprevir-based triple therapies. RGT strategies are dependent on highly sensitive and reproducible HCV RNA quantification. However, different HCV RNA assays are used in routine clinical practice and these differ significantly in their performance characteristics. The development of IFN-free therapies has fundamentally changed the role of on-treatment HCV RNA for SVR prediction. Given the high efficacy and excellent tolerability of IFN-free regimens, the interest in treatment individualization has decreased. However, shorter treatment durations may still be desirable, particularly with respect to the high costs of current IFN-free direct-acting antiviral agents (DAAs). Moreover, some difficult-to-treat patients remain, e.g., those infected with HCV genotype 3 in whom the current standard of care may not always be sufficient to achieve SVR, especially in treatment-experienced patients with cirrhosis. Here, a RGT extension may be feasible. However, current data on the predictive value of on-treatment HCV RNA are limited and have shown conflicting results. As more potent DAAs become available, the role of response prediction may diminish further. Currently, shorter treatment duration is only based on baseline HCV RNA whereas no RGT strategy is recommended for any of the approved DAA regimens available.

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Effectiveness and safety of sofosbuvir plus ribavirin for the treatment of HCV genotype 2 infection: results of the real-world, clinical practice HCV-TARGET study

Cited by 76 publications

References 29 publications

Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Interferon-free treatments in patients with hepatitis C genotype 1-4 infections in a real-world setting

Management of post liver transplantation recurrent hepatitis C infection with directly acting antiviral drugs: a review

Diagnostics in hepatitis C: The end of response-guided therapy?

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