Why is Sovaldi approved as the drug?

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Why is Sovaldi approved as the drug?

Sovaldi is a hepatitis C virus nucleotide analog NS5B polymerase inhibitor administered for the treatment of chronic hepatitis C infection as an essential part of a combination antiviral treatment course. Sovaldi efficacy has been confirmed in patients with HCV genotype 1, 2, 3 or 4 infection, plus those with hepatocellular carcinoma awaiting liver transplantation surgery and those suffering from HCV/HIV-1 co-infection.

Sovaldi comes in the form of a yellow colored, capsule-shaped, film-coated pill stamped with «GSI» on one side and with figures «7977» on the other side. Each pill contains 400 mg Sofosbuvir — the active component.

The Agency’s Committee for Medicinal Products for Human Use decided that Sovaldi’s benefits are greater than its risks and advised that it be approved for usage in the EU. The CHMP considered that introduction of Sovaldi to normal treatment is suitable to patients. Sovaldi lets the infection to be eliminated without the patient having to use Peginterferon alfa or during only short-term courses of this medicine (which may lead to serious adverse reactions and is not well endured by many patients).

The Committee also came to conclusion that, if used before a liver transplant surgery, Sovaldi in combination with Ribavirin can hinder re-infection of the liver, which in the absence of correct treatment occurs almost always and predicts poor prognosis for the future. Additionally, virus resistance to Sovaldi is very uncommon and Sovaldi functions against all types of Hepatitis C virus.

Concerning safety, the Committee pointed that, although there is restricted information in some patient categories such as those with decompensated liver disease, no adverse reactions related to Sovaldi have been observed, and those registered are primarily due to combined treatment with Ribavirin or Interferons. When Sovaldi is used in combination with Ribavirin or Peginterferon alfa/ribavirin, the contraindications related to those drugs are also applicable to combination therapies course. Read carefully the prescribing information of Peginterferon alfa and Ribavirin for a comprehensive list of their contraindications.

Any patient should bear in mind the following aspects when starting treatment with Sovaldi:

  • Monotherapy of Sovaldi is not advised for treatment of CHC.
  • Treatment course and length are based on both viral genotype and patient categories.
  • Treatment response is based on host and viral factors.