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• W2015196323 abstract "The proof of concept that patients could achieve SVR without IFN or RBV was first demonstrated with the NS5A inhibitor, Daclatasvir, and the protease inhibitor (PI), asunaprevir, in 11 prior nonresponders. Four of 11 patients experienced SVR after 24 weeks of treatment. Treatment failure was primarily associated with PI resistant mutations and persons with genotype 1a showed inferior rates of response as compared to those with genotype 1b, due to a more frequent selection of variants bearing amino acid substitutions in both the NS5A and NS3 protease regions. With the initial proof of concept that HCV can be successfully treated without interferon, clinical research has focused on DAA treatment paradigms to optimize responses. Successful strategies include combinations of different classes of DAAs that have sufficient antiviral potency with non-overlapping resistance. While many regimens under evaluation have used nucleotide inhibitors as a backbone to achieve IFN-free therapy, combination regimens without nucleotides have also been successfully developed. A number of phase 3 programs are underway that should lead to approved regimens in 2014. The best examples of what to expect from these regimens can be seen in the phase 2 SOUND-C and AVIATOR studies. SOUND-C2 evaluated a PI, faldaprevir and a NNI, BI207127, with or without RBV. This study included 314 genotype 1 naïve patients who were treated for 16–24 weeks. While there was no difference in SVR rates in groups as a function of treatment length, there was a marked effect of RBV on SVR (69% versus 44% with and without RBV, respectively). This study also documented differences in response patterns according to subtype 1a and 1b as well as IL28B allele status. Response rates in patients with subtype 1a were influenced by IL28B genotype with CC patients demonstrating significantly higher SVRs than those having T allele. In contrast, subtype 1b subjects showed high SVR rates irrespective of IL28B genotype. AVIATOR is the most comprehensive non-NI DAA trial to date. The PI ABT-450/r was combined with the NS5A inhibitor ABT-267 and the NNI ABT-333 with and without RBV for durations of 8, 12, or 24 weeks. The study included 438 treatment naïve and 133 prior NRs of which 66% had genotype1a infection and over 70% were non-CC IL28B. SVR24 rates were comparable and all were 90% or greater for naïve as well as prior NRs for patients receiving all four drugs for 12 or 24 weeks. Furthermore, there was little, if any differences in SVR rates when data were tested for variables of RBV use, non-CC IL28B genotype or viral 1a subtype in either null or treatment naïve groups. Altogether, the DAA combination trials without nucleotides clearly demonstrate that regimens can be developed to deliver a safe and effective IFN-free therapy." @default.
• W2015196323 created "2016-06-24" @default.
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• W2015196323 date "2013-09-01" @default.
• W2015196323 modified "2023-09-23" @default.
• W2015196323 title "O132: Combination regimens without nucleotides" @default.
• W2015196323 doi "https://doi.org/10.1111/jvh.12165_8" @default.
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