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Photo :Epclusa training session [LLOQ:<1% (2/623)> <1% (1/209) 1% (1/118) 1% (2/327) 0/104 0/116 0/35 0/41 Other † 1% (4/624) 1% (3/210) 0/118 1% (3/328) 0/104 0/116 3% (1/35) 0/41 Genotype 2 HCV Infected Adults (ASTRAL-2) ASTRAL-2 was a randomized, open-label trial that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of treatment with SOF with ribavirin in subjects with genotype 2 HCV infection. Subjects were randomized in a 1:1 ratio to the treatment groups. Randomization was stratified by the presence or absence of compensated cirrhosis and prior treatment experience (treatment-naïve vs treatment-experienced). Demographics and baseline characteristics were balanced across the two treatment groups. Of the 266 treated subjects, the median age was 58 years (range: 23 to 81); 59% of the subjects were male; 88% were White; 7% were Black; 33% had a baseline body mass index at least 30 kg/m 2 ; 62% had non-CC IL28B alleles (CT or TT); 80% had baseline HCV RNA levels at least 800,000 IU/mL; 14% had compensated cirrhosis; and 15% were treatment-experienced. Table 11 presents SVR12 and other virologic outcomes from the ASTRAL-2 trial. Table 11 Study ASTRAL-2: Virologic Outcomes in Subjects with Genotype 2 HCV without Cirrhosis or with Compensated Cirrhosis (12 Weeks After Treatment) Epclusa 12 Weeks (N=134) SOF + RBV 12 Weeks (N=132) SOF = sofosbuvir; RBV = ribavirin. * The denominator for relapse is the number of subjects with HCV RNA>
<1% (1/275) Relapse * 4% (11/276) 14% (38/272) Other † 1% (2/277) 5% (15/275) SVR12 for selected subgroups are presented in Table 13. Table 13 Study ASTRAL-3: SVR12 by Prior Treatment and Presence/Absence of Compensated Cirrhosis in Subjects with Genotype 3 HCV Epclusa 12 Weeks SOF + RBV 24 Weeks * Treatment-Naïve (N=206) Treatment-Experienced (N=71) Treatment-Naïve (N=201) Treatment-Experienced (N=69) SOF = sofosbuvir; RBV = ribavirin. * Five subjects with missing cirrhosis status in the SOF + RBV 24-week group were excluded from this subgroup analysis. † One treatment-experienced subject without cirrhosis treated with Epclusa had genotype 1a HCV infection at failure, indicating HCV re-infection, and is therefore excluded from this analysis. Without cirrhosis 98% (160/163) 94% (31/33) † 90% (141/156) 71% (22/31) With compensated cirrhosis 93% (40/43) 89% (33/37) 73% (33/45) 58% (22/38) Clinical Trial in Subjects Coinfected with HCV and HIV-1 ASTRAL-5 was an open-label trial that evaluated 12 weeks of treatment with Epclusa in subjects with genotype 1, 2, 3, 4, 5 or 6 HCV infection who were coinfected with HIV-1. Subjects were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate or abacavir/lamivudine administered with atazanavir/ritonavir, darunavir/ritonavir, lopinavir/ritonavir, rilpivirine, raltegravir or elvitegravir/cobicistat. Of the 106 treated subjects, the median age was 57 years (range: 25 to 72); 86% of the subjects were male; 51% were White; 45% were Black; 22% had a baseline body mass index at least 30 kg/m 2 ; the proportions of patients with genotype 1, 2, 3, or 4 HCV infection were 74%; 10%; 11%, and 5% respectively; no subjects with genotype 5 or 6 HCV were treated with Epclusa; 77% had non- CC IL28B alleles (CT or TT); 74% had baseline HCV RNA levels of at least 800,000 IU/mL; 18% had compensated cirrhosis; and 29% were treatment experienced. The overall mean CD4+ count was 598 cells/µL (range: 183 1513 cells/µL) and 57% of subjects had CD4+ counts > 500 cells/µL. Table 14 presents the SVR12 for the ASTRAL-5 trial by HCV genotype. Table 14 Study ASTRAL-5: Virologic Outcomes by HCV Genotype in Subjects Coinfected with HIV-1 without Cirrhosis or with Compensated Cirrhosis (12 Weeks After Treatment) Epclusa 12 Weeks (N=106) Total (all GTs) (N=106) GT-1 GT-1a (N=66) GT-1b (N=12) Total (N=78) GT-2 (N=11) GT-3 (N=12) GT-4 (N=5) * The denominator for relapse is the number of subjects with HCV RNA> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Gilead Sciences, Inc. Drug Class Antiviral combinations Related Drugs antiviral combinations Harvoni , Truvada , Atripla , Genvoya , Triumeq , Stribild Hepatitis C Harvoni , ribavirin , Zepatier , Mavyret , Sovaldi , sofosbuvir , ledipasvir / sofosbuvir , Vosevi , Viekira Pak , daclatasvir , Daklinza , Pegasys , Intron A , Ribasphere , Olysio , sofosbuvir / velpatasvir , Rebetol , simeprevir , Moderiba , PegIntron , elbasvir / grazoprevir , glecaprevir / pibrentasvir , RibaPak , More... Epclusa Rating 75 User Reviews 8.0 /10 75 User Reviews 8.0 Rate it! Epclusa Images Epclusa sofosbuvir 400 mg / velpatasvir 100 mg (GSI 7916) View larger images} } customize
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