Encouraging efficacy with glecaprevir-pibrentasvir combo in HCV
Treatment with the direct-acting antiviral (DAA) combination of glecaprevir and pibrentasvir led to encouraging sustained virological response (SVR) among individuals with hepatitis C virus (HCV) infection, results of two real-world studies presented at the International Liver Congress™ (ILC 2019) showed.
Researchers of the first study used data of 1,698 adult patients with HCV genotype 1–6 from the German Hepatitis C-Registry, of whom 84 percent were treatment-naïve and did not have cirrhosis and received treatment with glecaprevir/pibrentasvir for 8 weeks. Of these, 26 percent of patients (n=439) were on opioid substitution therapy, 15 percent (n=247) had psychiatric disease, 6 percent (n=106) had a history of alcohol abuse, and 3 percent (n=47) were active drug users.
“These are all important comorbidities encountered in clinical practice that often have led to treatment being deferred in the past,” said study author Professor Markus Cornberg from the Hannover Medical School in Hannover, Germany.
SVR at 12 weeks (SVR12) in the intention-to-treat population was high in this study at 97 percent (n=964), with a 100 percent SVR12 rate among the 11 patients who were active drug users. [ILC 2019, abstract GS-07]
There were six incidences of HCV re-infection and six patients experienced a virological relapse. Thirteen patients discontinued treatment, three due to adverse events (AEs). Of the 10 serious AEs that occurred, three were deemed potentially treatment-related.
“We found glecaprevir/pibrentasvir treatment to be safe and highly effective, and to lead to significant improvements in reported physical and mental well-being*, across this large, primarily treatment-naïve cohort of HCV-infected individuals with typical comorbidities,” added Cornberg.
The effectiveness of two DAA regimens was demonstrated in another study, a US-based one using data from the Trio Health disease management programme. Patients in this study had HCV infection treated with either glecaprevir/pibrentasvir (n=1,131) or sofosbuvir/velpatasvir (n=777).
Ninety-three percent (n=1,049) of glecaprevir/pibrentasvir recipients achieved SVR 12, with 2 percent (n=17) completing therapy but not achieving SVR12, 2 percent (n=21) completing therapy but lost to follow up, 3 percent (n=38) discontinuing therapy, and 1 percent (n=6) dying. [ILC 2019, abstract THU-127]
Among sofosbuvir/velpatasvir recipients, 90 percent (n=701) achieved SVR12, 2 percent (n=15) completed therapy without achieving SVR12, 2 percent (n=14) were lost to follow up, 5 percent (n=40) discontinued therapy, and 1 percent (n=7) died.
The SVR12 rates were higher in the per-protocol population (98 percent in each treatment group). The SVR12 rates did not differ between treatment groups when assessed by genotype, fibrosis, prior treatment, and baseline viral load, except for a lower likelihood of SVR12 among patients with HCV genotype 3 and cirrhosis who received glecaprevir/pibrentasvir compared with sofosbuvir/velpatasvir (88 percent vs 98 percent; p=0.044).
Forty-five percent of sofosbuvir/velpatasvir recipients who discontinued therapy had HCV genotype 3 compared with 5 percent of glecaprevir/pibrentasvir recipients. Sixteen percent of glecaprevir/pibrentasvir recipients who discontinued therapy had severe renal impairment compared with 2 percent of sofosbuvir/velpatasvir recipients who discontinued therapy.
Factors associated with virological failure among glecaprevir/pibrentasvir recipients included cirrhosis (odds ratio [OR], 0.29, 95 percent confidence interval [CI], 0.11–0.80; p=0.017) and a viral load exceeding 6 MM in patients with HCV genotype 3 (OR, 0.14, 95 percent CI, 0.03–0.60; p=0.008). Among patients treated with sofosbuvir/velpatasvir, there was an elevated likelihood of virological failure among those who also received ribavirin therapy (OR, 0.16, 95 percent CI, 0.04–0.60; p=0.007).