The efficacy of Elbasvir/Grazoprevir fixed-dose combination for 8 weeks in HCV treatment and health-related quality of life (HRQoL) in treatment-naïve, non-cirrhotic, genotype 4-infected patients (ELEGANT-4): A single-center, single-arm, open-label, phase 3 trial

Ahmad AlEid, Areej Al Balkhi, Adel Qutub, Shahem Abbarh, Abed AlLehibi, Abdullah Almtawa, Nawwaf Al Otaibi, Ahmed AlGhamdi, Adel AlGhamdi, Abdulrahman Alamr, Shameem Ahmad, Khalid Al Sayari, Bashaar Al Ibrahim, Abdullah AlKhathlan, Ahmad AlEid, Areej Al Balkhi, Adel Qutub, Shahem Abbarh, Abed AlLehibi, Abdullah Almtawa, Nawwaf Al Otaibi, Ahmed AlGhamdi, Adel AlGhamdi, Abdulrahman Alamr, Shameem Ahmad, Khalid Al Sayari, Bashaar Al Ibrahim, Abdullah AlKhathlan

Abstract

Background: Cost, adverse events, and long treatment duration can be significant obstacles in treating hepatitis C virus (HCV)-infected individuals. Shortening the treatment regimen can minimize these barriers, thereby enhancing adherence and increasing medication availability to more patients.

Methods: This is a single-centre, single-arm, open-label, phase 3 clinical trial on treatment naïve, non-cirrhotic, HCV genotype 4 patients. The study aimed to evaluate an 8-week course of Elbasvir (ELB)/Grazoprevir (GZR) in this population. The primary endpoint was sustained virologic response at 12 weeks after the end of treatment (SVR-12). The secondary endpoints were SVR-4, adverse events, and changes in health- and hepatitis-related quality of life (HRQoL).

Results: Of the 30 patients who were enrolled, 29 (97%) achieved SVR-12 and SVR-4 (95% CI: 90-100%). No patients experienced serious or life-threatening adverse events (AEs), but mild/moderate AEs were reported by 16 (53%). The most commonly reported AEs were itching/skin rash (20%), headache (16.7%), abdominal/epigastric pain and decreased appetite (13.3% each), and nausea/vomiting (10%). Marked improvements in HRQoL were reported between the first (baseline) and third (SVR-12) timepoints. HRQoL score improvements involved the physical, mental, and hepatitis-specific indices, and ranged between 6 and 42 points (out of 100, P ≤0.003).

Conclusion: The trial provides empirical evidence that HCV genotype 4-infected patients can achieve viral eradication with an 8-week-regimen of ELB/GZR. Further, this course of treatment is associated with a minimal adverse event profile and potentially significant improvements in quality of life. (ClinicalTrials.gov number, NCT03578640).

Keywords: Elbasvir/Grazoprevir; Health-related quality of life; hepatitis C genotype 4; sustained virologic response.

Conflict of interest statement

None

Figures

Figure 1
Figure 1
Patient progress flowchart regarding SVR-related outcomes
Figure 2
Figure 2
Most commonly reported adverse events and their changes over time
Figure 3
Figure 3
Changes in the HQLQ scores over the study period. Chart (a) represents the scores of the physical and mental components, as well as the self-evaluated transition (SET) item. Higher scores on the physical and mental components reflect more favorable results. The opposite is true for the SET. SET scores are multiplied by 10 to showcase the trend clearly. Chart (b) showcases the overall trends for hepatitis-specific items. Higher scores on these indices represent more favorable outcomes

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