| abstract |
Disclosed is the use of ledipasvir and sofosbuvir in the manufacture of a medicament for the treatment of hepatitis C virus infection in a patient, wherein the medicament is in the form of a fixed dose combination tablet comprising: a) from about 10% to about 25% w/w of a solid dispersion comprising ledipasvir dispersed within a polymer matrix formed by copovidone, wherein the weight ratio of ledipasvir to copovidone in the solid dispersion is about 1:1 and wherein the ledipasvir is substantially amorphous; b) from about 35% to about 45% w/w of sofosbuvir, wherein sofosbuvir is substantially crystalline with XRPD 2theta-reflections (° ± 0.20) at: 6.1, 12.7 and 20.8; c) from about 5.0% to about 25% w/w of lactose monohydrate; d) from about 5.0% to about 25% w/w of microcrystalline cellulose; e) from about 1.0% to about 10% w/w of croscarmellose sodium; from about 0.5% to about 3% w/w of colloidal silicon dioxide; and g) from about 0.1% to about 3% w/w of magnesium stearate. In a preferred embodiment the fixed dose combination tablet comprises about 180 mg of a solid dispersion comprising ledipasvir dispersed within a polymer matrix formed by copovidone and about 400 mg of sofosbuvir; or else about 90 mg of a solid dispersion comprising ledipasvir dispersed within a polymer matrix formed by copovidone, and about 400 mg of sofosbuvir. The fixed dose combination tablet preferably further comprises a film coating. |