Nationwide registry of glecaprevir plus pibrentasvir in the treatment of HCV in Taiwan

Abstract

The study evaluated the real-world treatment outcomes of Glecaprevir/pibrentasvir (GLE/PIB) including effectiveness, safety and healthcare resource utilization based on a nation-wide registry in Taiwan. The Taiwan HCV Registry (TACR) is a nation-wide platform organized and supervised by the Taiwan Association for the Study of the Liver. Data were analyzed for patients treated with GLE/PIB, including 3144 patients who had treatment outcome available. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA throughout 12 weeks of end-of-treatment). The overall SVR12 rate was 98.9% (3110/3144), with 98.8%, 99.4% and 100% in patients receiving 8 weeks, 12 weeks, and 16 weeks of GLE/PIB respectively. The SVR12 rate in the treatment-naïve cirrhotic patients receiving 8 weeks of GLE/PIB was 98.2% (108/110). The most common AEs were fatigue (7.5%), pruritus (6.7%) and dizziness (1.5%). The mean number of outpatient visits during the GLE/PIB was 5.94 visits for patients treated with 8 weeks, significantly different from the patients treated with 12 weeks of GLE/PIB (6.90 visits). The results support the effectiveness and safety of GLE/PIB treatment in real-world clinical practice, and provide further evidence that the shorter, 8-week GLE/PIB regimen is effective and cost-saving.

Comparison of 8- versus 12-weeks of glecaprevir/pibrentasvir for Taiwanese patients with hepatitis C and compensated cirrhosis in a real-world setting

“…In line with other real-world studies, our study demonstrated that GLE/PIB was well tolerated by patients of Asian ethnicity with cirrhosis [ 19 , 24 – 29 ]. A total of four patients did not complete the treatment, and only one of those patients discontinued treatment because of potential GLE/PIB-related hyperbilirubinemia.…”

“…In contrast to the overall HCV genotype distribution in Taiwan, wherein genotype 1 is predominant [ 1 ], the preponderance of genotype 2 (62.26%) in this study reflected the evolution of DAAs, because the DAA regimens for treating genotype 1 infection were licensed and reimbursed earlier than those for other genotypes [ 17 , 19 ]. Although high viral load was previously associated with a high virological failure rate for genotype 2 patients receiving GLE/PIB [ 32 ], this phenomenon was not replicated in our genotype 2–dominant cohort, in which PP analysis suggested that all of the patients achieved SVR.…”

“…An integrated analysis of data from eight phase 2 or phase 3 trials revealed that the 8-week regimen of GLE/PIB was efficacious and well tolerated in treatment-naïve patients with HCV genotype 1 to 6 infections, with or without cirrhosis [ 22 ]. However, real-world data on the effectiveness of GLE/PIB treatment in patients with HCV and compensated cirrhosis remain limited, especially for the 8-week regimen and in an Asian population [ 19 , 24 ].…”

“…The excellent broad-spectrum antiviral activity, negligible side effects, and simple once-daily dosage of pangenotypic DAA combination regimens simplify health care service delivery and can help accelerate the realization of the HCV elimination goals [16]. Large-scale real-world data from Taiwan also supported the excellent effectiveness and safety profiles of both firstline pangenotypic DAAs, namely GLE/PIB and sofosbuvir/velpatasvir (SOF/VEL) [7,[17][18][19][20].…”

Sexually-transmitted hepatitis C virus reinfections among people living with HIV in Taiwan: the emerging role of genotype 6

“…In Taiwan, studies before 2005 universally demonstrated a very low prevalence of HCV genotype 6 in the general population [ 31 , 32 ]. After the outbreak of HIV and HCV among IDUs in 2005, studies have shown that the seroprevalence of HCV genotype 6 had increased to 5%–10% in the general population [ 33 , 34 ]. In terms of PLWH, the prevalence of HCV genotype 6 was around 20%–30%, which also was likely associated with IDUs who had HIV coinfection [ 35–37 ].…”