Sofosbuvir (whose trade names are Sovaldi and Virunon ) is a medicine that is used for the treatment of chronic hepatitis C , in combination with other drugs, it is not recommended as monotherapy.
The mechanism of action of the drug is an inhibition of the RNA polymerase enzyme of hepatitis C virus, this enzyme is essential for the multiplication of the virus. 1 It was discovered by Pharmasset and developed by Gilead Sciences .
The usual dose is 400 mg once a day orally, associated with other drugs, for at least 8 weeks.
Clinical use of sofosbuvir
Harvoni is used for the treatment of chronic hepatitis C, genotypes 1, 2, 3 and 4 in combination with ribavirin or associated with pegylated interferon and ribavirin.
It is also used for those patients who have hepatitis C simultaneously with infection by the human immunodeficiency virus , the causative agent of AIDS .
As of October 2014, it is used in combination with Ledipasvir with an indication for hepatitis C genotype 1. The treatment recommended by the FDA may be 8, 12 and 24 weeks depending on the stage and background.
Because sofosbuvir is used in combination with other medications, such as ribavirin and PEG interferon, only the effects of the combination of medications have been evaluated. The most commonly reported side effects are headache, nausea, skin rashes and irritability. 7
Indications for use in Spain
In 2014, the Sofosbuvir Therapeutic Positioning Report of the Spanish Agency for Medicines and Health Products indicated its use in certain circumstances (a.- clinical situations in which there is a need for treatment due to the advanced state of the disease and / or high risk of associated morbidity and mortality and there are no therapeutic alternatives or the existing ones are not adequate due to safety problems: in the liver transplant waiting list, liver transplant, cirrhosis (F4 in biopsy or Fibroscan ≥ 14.5 kPa, coinfected, patients with contraindications for treatment based on interferon or after failure to treatment with protease inhibitorsand b.- situations in which there is a need for treatment and therapeutic alternatives, sofosbuvir is considered an option with added therapeutic value based on efficacy and / or safety: patients with F3 on biopsy or Fibroscan> 9.5 Kpa., patients with F2 in biopsy or Fibroscan 7.6-9.5 Kpa.
A fall in prices is estimated – up to 13,000 euros per treatment in 2016 – and the verification that premature treatments reduce future expenses and are beneficial for the patient, allows predicting the disappearance of therapeutic limits to the administration of the drug.
A study carried out in 2017 by the University Hospital Complex of Pontevedra and the Pharmacoeconomics & Outcomes Research Iberia, calculates the number of patients treated at 66,777, between 2015 and 2016 and places the average cost of treatment at 24,167 euros for each patient.