Gilead’s Wonder Trio Combination Make a Leap in Hepatitis C Race
The U.S. based biopharmaceutical giant Gilead Sciences’ quest for the hepatitis C treatment has taken another leap.
Its wonder combination of the drug sofobuvir (SOF) and velpatasvir (VEL) along with investigational GS-9857 (a pan-genotypic protease inhibitor) demonstrated significant efficiency for treatment of patients with hepatitis C virus (HCV) who had failed non-structural 5A protein inhibitors (currently available direct-acting antivirals).
A 12 weeks Phase II trial evaluated the efficacy of the fixed dose combination of SOF/VEL/GS-9857, with or without ribavirin in genotype 1, DAA-experienced, HCV-infected patients, including patients with cirrhosis. Based on the promising results of Phase II, four Phase III studies are being conducted. US Food and Drug Association (FDA) has granted Breakthrough Therapy designation to the SOF/VEL/GS-9857 for treatment of genotype 1 chronic hepatitis C (CHC) infection in patients who have previously failed an NS5A inhibitor-containing regimen.
“Our study demonstrates that for HCV patients whose prior treatment has failed with the use of DAAs, this triple combination provides a high rate of sustained virologic response across HCV genotypes,” said Dr. Eric Lawitz, a professor at the University of Texas Health Science Center, San Antonio, and lead author of the study. “Furthermore, the study indicates that the treatment combination is generally safe and well tolerated by patients, providing a promising alternative for HCV sufferers who have limited re-treatment options.”
A 12 weeks Phase III study of the efficacy of SOF/VEL in genotype 1-6 HCV patients co-infected with HIV also showed well tolerance and significantly high SVR12 (sustained virological response) rates.
Gilead has been an old player in hepatitis C treatment. Its two drug that resurrected the hepatitis C treatment are- Sovaldi (sofosbuvir)– HCV nucleotide analog NS5B polymerase inhibitor for the treatment of CHC infection. Harvoni, which is a fixed dose combination of ledipasvir (HCV NS5A inhibitor) and sofosbuvir (HCV nucleotide analog NS5B polymerase inhibitor) targeted for the treatment of CHC genotype 1 infection, which also later got approved for genotype 4 , 5 , 6 CHC virus infection by FDA.
Merck’s Zepatier, Bristol-Myers Squibb’s Daklinza and AbbVie’s Technivie and Viekira Pak are also the tough competitors for Gilead in hepatitis C treatment competition.Would Gilead’s latest clinical trial results provide it the lead in the HCV treatment competition? Let us see in the coming time.
Featured image credit: Hepatitis Virus Cell – in detailed view © decade3d (Stock Photo ID: 69296935)