In the Journals

Zepatier safe, effective in black patients with HCV, comorbidities

Zepatier was effective and well-tolerated in black patients with hepatitis C genotype 1 and 4 compared with overall reported safety profile, according to recently published data.

“The results from this retrospective analysis of clinical trial data support the use of [elbasvir/grazoprevir (EBR/GZR)] in black individuals with HCV... infection,” Zamor wrote. “EBR/GZR showed high efficacy across many subgroups of black participants, including those with cirrhosis, [chronic kidney disease], HIV co-infection, or sickle cell disease, as well as those taking opioid agonist therapy, and was generally well tolerated, with a safety profile similar to that reported in the general population of participants in the EBR/GZR clinical trials.”

Zamor and colleagues gathered patient data from nine international phase 2/3 studies, including 317 black patients who received Zepatier (elbasvir/grazoprevir, Merck) for 12 weeks, 15 black patients who received elbasvir/grazoprevir with ribavirin for 16 weeks, and 1,310 nonblack participants who received 12 weeks of elbasvir/grazoprevir for comparison.

The study included patients with HIV coinfection, well-compensated Child-Pugh class A cirrhosis, and patients with stage 4 or 5 chronic kidney disease. Disease and demographic characteristics were generally similar between black patients and nonblack participants.

Among patients with HCV genotype 1 who received treatment for 12 weeks, the sustained virologic response rate was 93.7% in black patients and 94.2% in the comparison cohort, which was not significantly different. Of the 19 black patients who did not achieve SVR, 11 had virologic failure. Black patients with HIV coinfection and genotype 1 had a lower SVR rate of 89.8% compared with 95.1% in nonblack participants.

Among patients with HCV genotype 4 who received treatment for 12 weeks, SVR rates were 93.8% for black patients and 94.6% in the comparison cohort. One black patient relapsed. SVR was 100% in black patients with HIV coinfection and 96.4% in the comparison cohort.

All black patients with genotype 1 who received treatment for 16 weeks with ribavirin achieved SVR compared with 97.5% among nonblack participants.

According to the researchers, SVR was not influenced by the presence of chronic kidney disease, the rates of which were 93.4% in those with stage 1 to 3 disease and 94.2% in those with stage 4 or 5 disease.

Overall, the safety profile of elbasvir/grazoprevir was similar in black patients and the comparison cohort with a similar or slightly lower frequency of adverse drug-related events in black patients (30% vs. 36.6%). However, serious adverse events occurred more often in black patients (7.6% vs. 3.4%).

“The diverse population of black individuals included in this analysis is representative of a real-world HCV-infected population,” the researchers wrote. “Rates of SVR remained high among important subgroups, such as those with cirrhosis and HCV/HIV coinfection.” – by Talitha Bennett

Disclosure: Zamor reports he received research grants from and served as a speaker for AbbVie, Merck and Gilead. Please see the full study for the other authors’ relevant financial disclosures.

Zepatier was effective and well-tolerated in black patients with hepatitis C genotype 1 and 4 compared with overall reported safety profile, according to recently published data.

“The results from this retrospective analysis of clinical trial data support the use of [elbasvir/grazoprevir (EBR/GZR)] in black individuals with HCV... infection,” Zamor wrote. “EBR/GZR showed high efficacy across many subgroups of black participants, including those with cirrhosis, [chronic kidney disease], HIV co-infection, or sickle cell disease, as well as those taking opioid agonist therapy, and was generally well tolerated, with a safety profile similar to that reported in the general population of participants in the EBR/GZR clinical trials.”

Zamor and colleagues gathered patient data from nine international phase 2/3 studies, including 317 black patients who received Zepatier (elbasvir/grazoprevir, Merck) for 12 weeks, 15 black patients who received elbasvir/grazoprevir with ribavirin for 16 weeks, and 1,310 nonblack participants who received 12 weeks of elbasvir/grazoprevir for comparison.

The study included patients with HIV coinfection, well-compensated Child-Pugh class A cirrhosis, and patients with stage 4 or 5 chronic kidney disease. Disease and demographic characteristics were generally similar between black patients and nonblack participants.

Among patients with HCV genotype 1 who received treatment for 12 weeks, the sustained virologic response rate was 93.7% in black patients and 94.2% in the comparison cohort, which was not significantly different. Of the 19 black patients who did not achieve SVR, 11 had virologic failure. Black patients with HIV coinfection and genotype 1 had a lower SVR rate of 89.8% compared with 95.1% in nonblack participants.

Among patients with HCV genotype 4 who received treatment for 12 weeks, SVR rates were 93.8% for black patients and 94.6% in the comparison cohort. One black patient relapsed. SVR was 100% in black patients with HIV coinfection and 96.4% in the comparison cohort.

All black patients with genotype 1 who received treatment for 16 weeks with ribavirin achieved SVR compared with 97.5% among nonblack participants.

According to the researchers, SVR was not influenced by the presence of chronic kidney disease, the rates of which were 93.4% in those with stage 1 to 3 disease and 94.2% in those with stage 4 or 5 disease.

Overall, the safety profile of elbasvir/grazoprevir was similar in black patients and the comparison cohort with a similar or slightly lower frequency of adverse drug-related events in black patients (30% vs. 36.6%). However, serious adverse events occurred more often in black patients (7.6% vs. 3.4%).

“The diverse population of black individuals included in this analysis is representative of a real-world HCV-infected population,” the researchers wrote. “Rates of SVR remained high among important subgroups, such as those with cirrhosis and HCV/HIV coinfection.” – by Talitha Bennett

Disclosure: Zamor reports he received research grants from and served as a speaker for AbbVie, Merck and Gilead. Please see the full study for the other authors’ relevant financial disclosures.