In this open-label, randomized phase II trial, the efficacy of 12 weeks of GS-7977 plus pegIFN/RBV combination therapy appeared to be comparable to that of 24 weeks of GS-7977 plus pegIFN/RBV combination therapy.
PegIFN lambda-1a associated with fewer musculoskeletal events, influenzalike symptoms, and fewer hematologic adverse events.
SVR rates typically 56% to 68%, with response rates up to 82% seen with this combination.
Response to pegIFN/RBV lead-in therapy correlated with previous response and predicted SVR in previous pegIFN/RBV nonresponders retreated with boceprevir plus pegIFN/RBV.
Treatment with tegobuvir and GS-9256 plus peginterferon/ribavirin produced very rapid HCV RNA suppression in treatment-naive patients with genotype 1 HCV; however, safety signals indicating that tegobuvir may be associated with pancytopenia when administered with another direct-acting antiviral agent plus peginterferon/ribavirin resulted in discontinuation of quadruple therapy in this trial.
ABT-450/ritonavir plus ABT-072 plus ribavirin well tolerated through 12 weeks of treatment
Despite lack of OS benefit, brivanib improved TTP, DCR, and ORR
SVR rates lower (47%) in previous nonresponders to pegIFN/RBV, but no patients who completed treatment experienced virologic failure
Interferon-free regiment produced a 77% SVR24 rate in difficult-to-treat patients with genotype 1b HCV infection
In this randomized phase IIb trial, alisporivir with or without ribavirin maintained on-treatment virologic responses after early HCV RNA clearance, confirming that it has a high genetic barrier to resistance.
Although low rates of SVR12 were demonstrated among patients infected with genotype 1a HCV, the regimen was well tolerated with no occurrence of serious adverse events.
Safety, tolerability profiles similar for the 2 anemia management regimens
Preliminary results from this ongoing randomized phase II trial demonstrate potent antiviral activity of 24 weeks of GS-5885, GS-9451, tegobuvir, and ribavirin, with higher SVR rates observed in the 90-mg GS-5885 dosing arm compared with the 30-mg GS-5885 arm.
Daclatasvir plus GS-7977 associated with 100% rate of SVR4 among patients with genotype 1a/1b HCV infection and > 90% rate in patients with genotype 2 or 3 HCV infection in this phase IIa trial.
SVR24 rates of up to 85% were seen in previously relapsed patients, up to 75% in patients with previous partial response, and up to 51% in previous null responders.
In this multicenter cohort involving 28 patients with severe genotype 1 hepatitis C recurrence following liver transplantation, 56% to 70% of patients had undetectable HCV RNA following 8 weeks of treatment with boceprevir or telaprevir plus pegIFN/RBV (with or without 4-week pegIFN/RBV lead-in phase); however, patients experienced high rates of anemia and required frequent reductions in the dosage of calcineurin inhibitors.
SVR12 rate was substantially higher with boceprevir plus peginterferon/ribavirin vs peginterferon/ribavirin alone in HIV/HCV-coinfected patients receiving stable antiretroviral therapy who were naive to HCV therapy.
In this examination of data from phase III telaprevir trials, no patients with HCV RNA > 1000 IU/mL at Week 4 or Week 12 achieved sustained virologic response.
Miravirsen monotherapy over 4 weeks yielded dose-dependent HCV RNA reductions without evidence of viral resistance in treatment-naive patients chronically infected with genotype 1 HCV; no dose-limiting toxicities were observed.
Rates of serious adverse events were markedly higher in this study population than in phase III trials of telaprevir- and boceprevir-based therapy for patients with genotype 1 HCV infection.
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