METHODS: Patients who achieved SVR in
two NIAID open-label, phase 2 clinical trials of treatment with sofosbuvir/ ribavirin for 24 weeks (n=38), sofosbuvir/ledipasvir for 12 weeks (n=20), sofosbuvir/ledipasvir + GS-9669 for 6 weeks (n=19) or sofosbuvir/ledipasvir + GS-9451 for 6 weeks (n=19) were followed. HCV viral loads were measured with STA-9090 in vitro Abbott M2000 RealTime HCV assay with a limit of quantification of <12 IU/mL. RESULTS: Ninety-six patients with chronic hepatitis C genotype 1 infection [F/M: 36/60; GT-1A/1B: 68/28; median age: 55 years (range: 21-79 years); IL28B genotype CC/(CT/TT): 18/78; Black race/other races: 82/14; Fibrosis stage pre-treatment 3-4/0-2: 22/74] achieving SVR after IFN-free DAA therapy were followed for a median of 8.3 (0 to 22.6) months. No cases of late relapses were observed. All 96 patients
have maintained HCV viral loads at <12 IU/ mL beyond SVR 12 in follow up (Table 1). At the time of the follow up period, ALT, AST, and bilirubin levels remained normal in 96%, 91%, and 99% respectively. CONCLUSIONS: This study suggests that HCV eradication after IFN-free DAA therapy remains durable in long-term follow up. Follow up liver biopsies may be indicated to demonstrate whether prolonged SVR will lead to reversal of liver fibrosis. Table 1: Durability of response SVR in weeks Disclosures: The following people have nothing to disclose: Sara Jones, Miriam Marti, Zayani Sims, Anita Kohli, Sarah Kattakuzhy, Tess L. Petersen, Rachel Silk, Michael A. Polis, Henry Masur, Shyam Kottilil, Anu Osinusi Purpose: Interferon (IFN) can exacerbate underlying depression or bipolar disease; PF-562271 manufacturer thus, many patients with this history are poor candidates for IFN-based therapies. Adults with chronic GT1 hepatitis C virus infection, including those with compensated cirrhosis, achieved SVR12 rates of 90%-100% in phase 3 trials of the interferon-free
3D regimen of ABT-450 (dosed with ritonavir, ABT-450/r), ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin (RBV). We evaluated safety and efficacy of 3D ±RBV in patients with a history of depression 上海皓元医药股份有限公司 or bipolar disorder (DEP/BPD). Methods: In phase 3 trials, treatment-naïve or -experienced cirrhotic and non-cirrhotic patients received at least one dose of 3D ±RBV (co-formulated ombitasvir/ABT- 450/r, 25mg/150mg/100mg once daily, dasabuvir 250mg twice daily, ± weight-based RBV.) SVR12 rates, incidence of adverse events (AEs) and treatment discontinuation due to AE were determined for patients with and without a history of DEP/BPD at enrollment. Results: A greater percentage of patients with a history of DEP/BPD (357/2052, 17.4%) were female and treatment-experienced versus those without history of DEP/BPD. SVR12 rates were similar for both subgroups (>94.5%); virologic failure occurred in 1 (0.4%) patient with DEP/BPD history. The incidence of any AEs was higher for patients with DEP/BPD history compared to patients without DEP/BPO history; most AEs were mild.
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