Facts about SOVALDI Therapy



SOVALDI 

It is a nucleotide analog polymerase inhibitor, that use in patients with chronic hepatitis C, in combination with ribavirin or interferon plus ribavirin, and the cure rate in clinical trials reached 95%.

Here is some facts about SOVALDI that pharmacist must know:

  1. Active constituent of SOVALDI is sofosbuvir 400 mg.
  2. SOVALDI is effective against the four genotypes of HIV infection, including patients with HCC that in waiting list for liver transplantation, and those carrying HIV-1/HCV co-infection.
  3. SOVALDI not recommended using alone for Chronic Hepatitis C patients.
  4. The dose of SOVALDI is 400 mg once daily, to be taken regardless of food.
  5. Genotype-1 HCV treated for 12 weeks with SOVALDI +Peginterferon alfa +ribavirin, and for 24 weeks if used without peginterferon alfa.
  6. Genotype-2 HCV treated for 12 weeks with SOVALDI +ribavirin.
  7. Genotype-3 HCV treated for 24 weeks with SOVALDI +ribavirin.
  8. Genotype-4 treated for 12 weeks with SOVALDI +Peginterferon alfa +ribavirin.
  9. CHC+HCC in waiting list for liver transplantation, treated with SOVALDI+ribavirin for 48 weeks, or until the operation.
  10. Because SOVALDI not used alone, all contra-indications that applied to interferon and ribavirin extend to affect the combination.
  11. Pregnancy test must be done before initiation of treatment, whether the patient is female or married male, to exclude pregnancy, due to toxic effect of ribavirin to fetus.
  12. Female on ribavirin therapy, or wife of male on ribavirin therapy, must use at least two effective contraceptive methods other than hormonal one, and make pregnancy test every month and continuo for 6 months after stoppage of ribavirin.
  13. There is no modification in SOVALDI dose, but if the other components of its combination are stopped permanently, it must stop.
  14. SOVALDI not used with potent P-gp inducers as rifampicin, due to they decrease plasma concentration of sofosbuvir.
  15. Safety and effectiveness of SOVALDI in children less than 18 years of age have not been established.
  16. SOVALDI has no dose recommendation in case of severe renal impairment, and end stage renal disease that is need hemodialysis.

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