Twelve weeks of treatment in noncirrhotic patients proved to be highly efficacious, yielding very high SVR12 rates regardless of HCV subgenotype or previous treatment response, including in patients with previous null response to peginterferon/ribavirin.
SVR4-24 rates reached 94% to 98% with 12 weeks of therapy, with no apparent additional benefit conferred by the use of ribavirin.
All 4 regimens achieved similar high SVR12 rates and were safe and well tolerated, although cirrhotic patients appeared to achieve higher SVR12 rates with the 24-week regimens.
In a phase II study, the regimen was efficacious and well tolerated with no toxicity-driven discontinuations.
In a phase II study, to date, 96% of patients achieved SVR12 following 24 weeks of therapy, with no adverse effects on graft function.
Sofosbuvir/ledipasvir was also well tolerated, with no grade 4 adverse events, 1 grade 3 adverse event, no discontinuations for toxicity, and no effect on HIV-1 RNA or CD4+ cell count.
Regimen well tolerated and SVR12 rates similar regardless of 12- vs 24-week treatment duration.
Extending treatment duration to 24 weeks or adding ribavirin did not increase SVR rates.
SVR12 rates reached 93% to 100% regardless of treatment duration or the addition of ribavirin
SVR12 rates in phase III study exceeded 80% in previous null/partial responders and cirrhotics.
SVR12 rates 93% to 95% across treatment arms with fewer adverse events and laboratory abnormalities in RBV-free arms.
Interim results also suggest high early virologic response rates in treatment-experienced noncirrhotic patients with genotype 4 HCV.
SVR12 rates ranged from 64% to 100% following treatment with a novel all-oral regimen in patients with genotype 3 HCV, or genotype 1 HCV and decompensated cirrhosis, or genotype 1 HCV and failure on previous sofosbuvir-containing therapy.
Triple DAA + ribavirin regimen was also well tolerated, with low rate of treatment discontinuation due to adverse events.
High SVR rates attained with MK-5172 + MK-8742 regimens in hard-to-treat patients, regardless of HCV subgenotype and previous treatment response.
In addition to high rates of on-treatment virologic suppression, other benefits included decreased necroinflammation with ALT normalization, improvements in platelet count and albumin levels, and resolution of ascites and hepatic encephalopathy.
Presence of the Q80K variant at baseline in patients with genotype 1a HCV and IL28B TT genotype predicted an inferior response to treatment among previous null responders with genotype 1 HCV and METAVIR F0-F2.
A 12-week regimen of sofosbuvir plus pegIFN/RBV produced higher virologic response rates overall, particularly in patients with cirrhosis, as compared with a 24-week regimen of sofosbuvir/RBV.
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