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C-EDGE CO-INFECTED: Phase 3 Study of Grazoprevir / Elbasvir in Patients with HCV/HIV
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Reported by Jules Levin
IAS 2015, July 19-22, 2015, Vancouver
8th IAS Conference on HIV Pathogenesis, Treatment and Prevention, July 19-22,
Vancouver, Canada BC
Webcast:
https://www.youtube.com/watch?v=hunEgojbH3A
Jurgen Rockstroh et al
The Lancet HIV - Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial - (07/10/15)
AN 191535 is a 43 year old male, non-black or African American, non-Hispanic or Latino, GT1a, non-cirrhotic, with CT IL28B GT, with HIV on an ARV regimen of tenofovir, emtricitabine, and rilpivirine. He was allocated to a regimen of MK-5172 (100mg) and MK-8742 (50mg) experienced an Hep C RNA relapse on his follow-up 12 visit (02 Jan 2015). Baseline HCV RNA=436,155 with a 4.13 log10 drop from Day to Day7; Day7 HCV RNA=32. HCV RNA was undetectable from TW2 through FW8. At FW12, HCV RNA=371,192. Viral failure was confirmed on 22-Jan-15. Genotype from the failure confirmation visit was GT3a, and phylogenetic analysis supports reinfection. The site provided information that the subject is engaged in high risk behavior including MSM/unprotected anal intercourse and intravenous drug use and sharing needles. HIV RNA was undetectable at Day1 and remained undetectable throughout the treatment period.
The subject did experience the adverse event of insomnia, graded as mild, and which was assessed to be drug-related, as well as mild gastroenteritis which was assessed to be not drug-related.
Medical history includes anxiety, depression, anal injury, and insomnia. Medications include tenofovir, emtricitabine, rilpivirine and diazepam.
AN 191554 is a 35 year old male, non-black or African American, non-Hispanic or Latino, GT1b, non-cirrhotic, with TT IL28B GT, with HIV on an ARV regimen of abacavir, lamivudine and raltegravir who was allocated to a regimen of MK-5172 (100mg) and MK-8742 (50mg) experienced an Hep C RNA relapse on his follow-up 12 visit (29 Dec 2014). Baseline HCV RNA=412,609 with a 3.94 log10 drop from Day 1 to Day7; Day 7 HCV RNA=47. HCV RNA was undetectable at TW2 through FW8. At FW12, HCV RNA=2952.
Viral failure was confirmed on 12 January 2015. The site confirmed the patient demonstrated excellent medication compliance and is not engaged in any high risk behaviors. Follow-up testing for HCV genotype revealed GT3 at failure and sequencing and phylogenetic analysis supports reinfection.
HIV RNA was undetectable at Day1 and remained undetectable throughout the treatment period and through FW8. At FW12, HIV RNA=49 copies/mL. The subject did experience the adverse events of fatigue, constipation, rectal hemorrhage, asthenia, and decreased appetite, all of which were graded as mild and assessed as not related to study drug. Medical history is notable for depression, ex-drug abuse, head injury and current tobacco use. Medications include abacavir, lamivudine, raltegravir, bisacodyl, lactulose, and methadone.
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