15 Facts about HARVONI the recent Hepatitis C from Gilead

HARVONI 

It is a combination of ledipasvir (90mg), a (HCV) NS5A inhibitor, and sofosbuvir (400mg), an HCV nucleotide analog NS5B polymerase inhibitor. HARVONI was approved by FDA on 10 October 2014, as first Hepatitis C drug combination, that used alone without need to ribavirin or peginterferon alfa, as in case of SOVALDI.

Harvoni 15 facts:

1. Used for treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.
2. HARVONI dose is one tablet to be taken once daily regardless of food.
3. Treatment duration varies according to the case and presence of liver cirrhosis.
4. In naive cirrhotic or not, and in experienced non cirrhotic, they treated for 12 weeks.
5. In naive non-cirrhotic patient with PCR < 6million IU/ml, treatment may reduced to 8 weeks.
6. In experienced cirrhotic patients the treatment extends for 24 weeks.
7. Experienced patients who have failed to treat with other medications.
8. HARVONI used alone without the need to peginterferon alfa or ribavirin.
9. HARVONI has no contraindication as mentioned in Glead Official prescription information.
10. Fatigue and headache are the most common adverse effects observed with HARVONI.
11. Not used with P-gp inducers as rifampin and St. John's wort drugs.
12. Not used in concomitant with SOVALDI.
13. No dose recommendation for patient with severe renal impairment and ESRD.
14. Use in pregnancy and lactation, not recommended because of lake of safety information.
15. No dose modification in mild, moderate or severe hepatic impairment, but no safety information available for decompensated liver cirrhosis.

For more information read the complete drug information.