Sofosbuvir/velpatasvir: a pangenotypic drug to simplify HCV therapy

Lee, Rebecca; Kottilil, Shyam; Wilson, Eleanor

doi:10.1007/s12072-016-9776-8

Cited by 28 publications

(27 citation statements)

References 35 publications

(70 reference statements)

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“…The SOF/VEL regimen was recently approved as a fixed-dose combination pill, called Epclusa ® , in the USA. As shown in the results from the clinical study,20 this regimen was beneficial for patients with HCV genotype 3 infections, who had no effective therapeutic options until approval of this medication 38. It is also possible that this DAA combination could safely and effectively cure patients with decompensated cirrhosis, irrespective of HCV genotypes.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety outcomes of sofosbuvir-based treatment regimens for hepatitis C virus-infected patients with or without cirrhosis from phase III clinical trials

Yang

Choi

2017

TCRM

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BackgroundWith the appearance of oral direct-acting antivirals (DAAs), the field of hepatitis C virus (HCV) treatment has been dramatically changed. This evolution makes possible for all oral treatments to be available for the treatment of HCV-infected patients. The aims of this review were to report the efficacy and safety of sofosbuvir (SOF)-based regimens for the treatment of patients with chronic HCV infection and to provide our clinical perspectives on these regimens.MethodsA literature search of clinical studies published in PubMed and posted on ClinicalTrials.gov website was performed to identify studies evaluating the efficacy or safety of SOF-containing treatment regimens.ResultsA total of 23 clinical trials were examined in the review. The evaluated SOF-based regimens are as follows: SOF/daclatasvir (DCV) ± ribavirin (RBV), SOF/ledipasvir (LDV) ± RBV, SOF/simeprevir (SMV), SOF/velpatasvir (VEL) ± RBV, and SOF/RBV ± peginterferon (peg-IFN). These SOF-based regimens were at least effective and safe for HCV-infected patients with or without cirrhosis. The SOF/VEL ± RBV regimen, a pan-genotypic DAA regimen, was effective for the treatment of patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection. The 24-week SOF/RBV regimen was as effective as the 12-week SOF/RBV/peg-IFN regimen. Patients with HCV genotype 3 infection could have benefits from the use of the 24-week SOF/RBV regimen. For cirrhotic patients with HCV genotype 3 infection, the 12-week SOF/RBV/peg-IFN regimen could be considered as an alternative treatment option when access to SOF-based regimens with other DAAs is limited. In the included studies, significant adverse events due to SOF-based regimens were not reported.ConclusionThe clinical trials suggest that SOF-based treatment regimens for HCV-infected patients with or without cirrhosis can be at least effective and safe patient-convenient medications. However, it is necessary to monitor HCV-infected patients, since rare adverse events, drug–drug interactions, and drug–disease interactions can occur in real clinical settings.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety outcomes of sofosbuvir-based treatment regimens for hepatitis C virus-infected patients with or without cirrhosis from phase III clinical trials

Yang

Choi

2017

TCRM

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“…However, there is a now a pan-genotypic DAA, sofosbuvir/velpatasvir, that has been approved for the treatment of genotypes 1 through 6, which can have implications worldwide given the decreased need for expensive laboratory testing and simplicity of treatment. 9 Although current head-to-head studies are ongoing, it appears that achieving sustained virologic response (SVR) is the most important factor for decreased risk of HCC and improvement of outcomes.…”

Section: Hepatitis C Virusmentioning

confidence: 99%

The Role of Diagnosis and Treatment of Underlying Liver Disease for the Prognosis of Primary Liver Cancer

et al. 2017

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Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related deaths worldwide. Underlying chronic liver disease has been associated with an increased risk of developing HCC. This study is a review of the current literature regarding the diagnosis, prognostic significance, and role of treating underlying liver disease in patients who are at risk of primary liver cancer. Relevant peer review of the English literature between 1980 and 2017 within PubMed and the Cochrane library was conducted for scientific content on current advances in managing chronic liver diseases and the development of hepatocellular carcinoma. Hepatitis C virus, hepatitis B virus (HBV), nonalcoholic steatohepatitis, autoimmune hepatitis, hereditary hemochromatosis, Wilson disease, primary biliary cirrhosis, α 1-antitrypsin deficiency, and certain drugs lead to an increased risk of developing HCC. Patients with underlying liver disease have an increased incidence of HCC. Hepatitis C virus, HBV, and hemochromatosis can directly lead to HCC without the presence of cirrhosis, while HCC related to other underlying liver diseases occurs in patients with cirrhosis. Treating the underlying liver disease and reducing the progression to cirrhosis should lead to a decreased incidence of HCC.

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“…Given this reason, sofosbuvir plus ledipasvir is not recommended for use in genotypes 2 and 3. On the other hand, the combination of sofosbuvir with another NS5A inhibitor velpatasvir as a oncedaily, single-tablet, pangenotypic regimen was recently approved for the treatment of adults with chronic HCV genotypes 1-6 in the USA, EU and Canada (22). In the phase III ASTRAL trials, once-daily oral sofosbuvir plus velpatasvir for 12 weeks provided high rates of SVR12 in treatment-naive and -experienced patients with chronic HCV genotype 1-6 infection (22).…”

Section: Sofosbuvir and Combination Therapiesmentioning

confidence: 99%

Research progress on the direct antiviral drugs for hepatitis C virus

Gao

2017

BST

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Sofosbuvir/velpatasvir: a pangenotypic drug to simplify HCV therapy

Cited by 28 publications

References 35 publications

Efficacy and safety outcomes of sofosbuvir-based treatment regimens for hepatitis C virus-infected patients with or without cirrhosis from phase III clinical trials

Efficacy and safety outcomes of sofosbuvir-based treatment regimens for hepatitis C virus-infected patients with or without cirrhosis from phase III clinical trials

The Role of Diagnosis and Treatment of Underlying Liver Disease for the Prognosis of Primary Liver Cancer

Research progress on the direct antiviral drugs for hepatitis C virus

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