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Background: Pangenotypic, once-daily glecaprevir (identified by AbbVie and Enanta)/pibrentasvir (G/P) has demonstrated high rates of sustained virologic response at 12 weeks post-treatment (SVR12) in patients with hepatitis C virus (HCV) genotype (GT) 1-6 infection. This phase 3 study evaluated the efficacy and safety of G/P in patients with chronic HCV GT1-6 infection and HIV-1 co-infection, including patients with compensated cirrhosis.
Methods: EXPEDITION-2 (NCT02738138) is a phase 3, multicenter, open-label study evaluating G/P (300 mg/120 mg) treatment in HCV/HIV-1 co-infected adults without or with compensated cirrhosis for 8 or 12 weeks, respectively. Patients were either HCV treatment-naïve or experienced with interferon (IFN), pegylated IFN ± ribavirin, or sofosbuvir + ribavirin ± pegylated IFN. GT3 treatment-experienced patients were excluded. The primary endpoint was the proportion of patients with sustained virologic response (HCV RNA < lower limit of quantification) 12 weeks post-treatment (SVR12).
Results: In total, 153 patients were enrolled, including 16 (10%) with cirrhosis. Baseline demographics are shown in Table 1. In patients with available data, rates of response at end of treatment and post-treatment week 4 were 98.7% (151/153) and 98.6% (144/146) respectively. To date, there is one (1/153; 0.65%) virologic failure: a breakthrough in a patient with GT3a infection and cirrhosis. The most common adverse events (AEs) were fatigue (16/153; 10%) and nausea (13/153; 8%). Three patients (2%) had serious AEs, and one serious AE of stroke led to treatment discontinuation on Day 23 in one patient with cirrhosis; all were unrelated to G/P. All patients maintained HIV-1 suppression (< 200 copies/mL) during treatment.

Table 1. Baseline Demographics & Characteristics
[Table 1. Baseline Demographics & Characteristics]


Conclusions: G/P for 8 weeks in non-cirrhotic and 12 weeks in cirrhotic patients is a well-tolerated and highly efficacious pangenotypic treatment for HCV/HIV-1 co-infection, regardless of baseline HCV RNA or treatment experience. Full SVR12 rates and prevalence of baseline NS3 and NS5A polymorphisms will be presented.