Phase 3 Treatment Naïve HIV Coinfection

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Presentation transcript:

Phase 3 Treatment Naïve HIV Coinfection Elbasvir-Grazoprevir in HCV and HIV Coinfection, GT 1, 4 or 6 C-EDGE CO-INFECTION Rockstroh JK, et al. Lancet HIV. 2015;2:e319-27.

Elbasvir-Grazoprevir in HCV-HIV Coinfection GT 1, 4 or 6 C-EDGE CO-INFECTION: Study Features C-EDGE Trial Design: Prospective, open-label, single-arm study examining the safety and efficacy of a fixed-dose combination of elbasvir-grazoprevir for 12 weeks in treatment-naïve patients with chronic HCV genotype 1, 4, or 6 and HIV coinfection. Entry Criteria - Chronic HCV Genotype 1, 4, or 6 - 18 years or older - HCV RNA ≥10,000 IU/mL - No prior treatment - Compensated cirrhosis permitted - HIV infection Primary End-Point: SVR12 Source: Rockstroh JK, et al. Lancet HIV. 2015;2:e319-27.

Elbasvir-Grazoprevir Elbasvir-Grazoprevir in HCV-HIV Coinfection GT 1, 4 or 6 C-EDGE CO-INFECTION: Study Design Week 12 24 HIV-HCV Coinfected Treatment-naïve GT 1, 4 or 6 Elbasvir-Grazoprevir N=218 SVR12 Drug Dosing Elbasvir-grazoprevir (50/100 mg): fixed dose combination; one pill once daily Source: Rockstroh JK, et al. Lancet HIV. 2015;2:e319-27.

Elbasvir-Grazoprevir (N=218) Elbasvir-Grazoprevir in HCV-HIV Coinfection GT 1, 4 or 6 C-EDGE CO-INFECTION: Participants Baseline Characteristic Elbasvir-Grazoprevir (N=218) Age, mean 49 Male, n (%) 183 (84%) Race, n (%) White Black or African-American Other 167 (77%) 38 (17%) 13 (6%) HCV genotype, n (%) 1a 1b 4 6 144 (66%) 44 (20%) 28 (13%) 2 (1%) Fibrosis stage, n (%) F0-2 F3 F4 160 (73%) 23 (11%) 35 (16%) Mean baseline HCV RNA, log10 IU/ml 6.03 Source: Rockstroh JK, et al. Lancet HIV. 2015;2:e319-27.

Elbasvir-Grazoprevir (N=218) Elbasvir-Grazoprevir in HCV-HIV Coinfection GT 1, 4 or 6 C-EDGE CO-INFECTION: Participants HIV Characteristics Elbasvir-Grazoprevir (N=218) Median CD4 cell count, (IQR) 568 (424-766) ART Status On ART with undetectable HIV RNA ART naïve 211 (97%) 7 (3%) ART nucleos(t)ide pair Abacavir-containing Tenofovir-containing None 47 (22%) 164 (75%) ART Third Agent Raltegravir Dolutegravir Rilpivirine 113 (52%) 59 (27%) 38 (17%) 8 (4%) IQR = interquartile range; ART = antiretroviral therapy Source: Rockstroh JK, et al. Lancet HIV. 2015;2:e319-27.

C-EDGE CO-INFECTION: SVR12 Results by Genotype Elbasvir-Grazoprevir in HCV-HIV Coinfection GT 1, 4 or 6 C-EDGE CO-INFECTION: Results C-EDGE CO-INFECTION: SVR12 Results by Genotype 210/218 139/144 42/44 27/28 Overall SVR12 results includes the 2 patients with GT 6, who both achieved SVR12. Source: Rockstroh JK, et al. Lancet HIV. 2015;2:e319-27.

Elbasvir-Grazoprevir (N=218) Elbasvir-Grazoprevir in HCV-HIV Coinfection GT 1, 4 or 6 C-EDGE CO-INFECTION: Adverse Events Adverse Event (AE), n (%) Elbasvir-Grazoprevir (N=218) Discontinuation due to AE Serious AEs 2 (1%) Deaths Any AE in >5% of patients Fatigue Headache Nausea Upper respiratory tract infection Diarrhea Insomnia 29 (13%) 27 (12%) 20 (9%) 18 (8%) 16 (7%) 15 (7%) Grade 3 or 4 laboratory abnormality Total bilirubin ALT elevation AST elevation Hemoglobin Grade 3 1 (<1%) 3 (1%) Grade 4 Source: Rockstroh JK, et al. Lancet HIV. 2015;2:e319-27.

Elbasvir-Grazoprevir in HCV-HIV Coinfection GT 1, 4 or 6 C-EDGE CO-INFECTION: Conclusions Conclusions: “This HCV treatment regimen seems to be effective and well tolerated for patients co-infected with HIV with or without cirrhosis. These data are consistent with previous trials of this regimen in the monoinfected population. This regimen continues to be studied in phase 3 trials.” Source: Rockstroh JK, et al. Lancet HIV. 2015;2:e319-27.