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Hepatitis C: sofosbuvir + velpatasvir (Epclusa°) represents an advance for some patients

The combination sofosbuvir + velpatasvir (Epclusa°) offers a therapeutic advance in the treatment of hepatitis C, especially in patients infected by a genotype 2 virus. But the uncertainty surrounding its adverse effects is unacceptable.

Hepatitis C can cause complications such as cirrhosis and liver cancer. Treatment depends on the virus genotype, the severity and progression of liver disease, the patient characteristics, the risk of drug interactions and possible failures of previous treatment. In most cases, the first-choice treatment is sofosbuvir + ledipasvir, with the addition of ribavirin in cirrhosis. In patients infected with a genotype 2 virus (HCV-2), the combination of sofosbuvir + ribavirin is effective in approximately 80% of cases. In patients infected with a genotype 3 virus (HCV-3), in the absence of cirrhosis, sofosbuvir + daclatasvir is effective in approximately 95% of cases.

Velpatasvir in fixed-dose combination with sofosbuvir (Epclusa°, Gilead) has been approved for the treatment of adult patients with hepatitis C, regardless of the genotype of the virus, based on five clinical trials.

In HCV-2 infected patients, the combination of sofosbuvir + velpatasvir is more effective than the reference combination of sofosbuvir + ribavirin, including in cases of cirrhosis. It also appears to be more effective for HCV-3, but there has been no comparative trial.In patients infected with HCV-1,4,5 or 6, the efficacy of sofosbuvir + velpatasvir appears to be similar to that of sofosbuvir + ledipasvir, but Gilead, which markets these two combinations, has not taken the trouble to compare them directly. 

The Epclusa° patient leaflet does not mention any specific adverse effects: this withholding of information is unacceptable given the adverse effects observed in clinical trials and those mentioned in the sofosbuvir patient leaflet.

©Prescrire 1 April 2018

"Sofosbuvir + velpatasvir (Epclusa°) in chronic hepatitis C. An advance in HCV genotype 2 infection" Prescrire Int 2018; 27 (192): 89-92 (Pdf, subscribers only).

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Gilead and the EMA
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Ombitasvir + paritaprevir
+ ritonavir. Hepatitis C:
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Daclatasvir. In chronic HCV
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Ledipasvir + sofosbuvir.
A therapeutic advance in
genotype 1 hepatitis C
virus infection, despite
uncertainties
Prescrire Int 2015;
24 (166): 285-289.
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Simeprevir. Chronic hepatitis C:
an option for some patients
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24 (160): 120.
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Sofosbuvir. Active against
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