Merck’s hepatitis C virus (HCV) treatment Zepatier (elbasvir/grazoprevir) posted excellent real-world results in an analysis of a large population of veterans with genotype 1 or 4 of the virus, including a high proportion of those with other health and mental health conditions.
Researchers analyzed data from the Veterans Affairs Corporate Data Warehouse on 2,985 people with hep C who were treated with Zepatier between February 1 and August 1, 2016. They excluded from their final analysis 23 people who took ribavirin for longer than a month, 484 people without sufficient follow-up data to determine whether they were cured and 32 people who were treated with Zepatier for longer than 17 weeks. This left a final study population of 2,436 veterans.
Findings were presented at the 52nd International Liver Congress in Amsterdam.
The average age of the final cohort was 63.5 years old. A total of 33.2 percent had cirrhosis, 53.2 percent had diabetes, 57.2 percent had depression and 3 percent were coinfected with HIV. Additionally, 53.9 percent had a history of drug abuse and 60.5 percent had a history of alcohol abuse. A total of 1,988 of the cohort had not been treated before and 448 had.
Overall, 95.6 percent (2,328 of 2,436) of the cohort achieved a sustained virologic response 12 weeks after completing therapy with Zepatier (SVR12, considered a cure). In the case of 19 percent of the cohort, there was no available record of a hep C viral load test 12 weeks after finishing treatment, so to determine whether these individuals had been cured, the researchers relied on tests conducted four weeks post-treatment as well as tests conducted past that point but prior to 12 weeks post-treatment.
Cure rates by genotype were: genotype 1, 95.4 percent (2,218 of 2,314), including 93.4 percent of genotype 1a (788 of 844) and 96.6 percent of genotype 1b (1,379 of 1,428), and 96.9 percent of genotype 4 (62 of 64).
Cure rates by hep C viral load upon starting treatment were: 94.7 percent (1,497 of 1,580) of those with a baseline viral load greater than 800,000 international units per milliliter and 97.3 percent for those with a baseline viral load equal to or below that threshold.
Broken down by the baseline characteristics of the cohort members, the cure rates were: males, 95.5 percent (2,245 of 2,350); females, 96.5 percent (83 of 86); African Americans, 95.9 percent (1,342 of 1,400); Latinos, 95.1 percent (77 of 81); whites, 95 percent (783 of 824); those who were first-timers to treatment, 96.1 percent (1,910 of 1,988); those who had been treated before, 93.3 percent (418 of 448); those with cirrhosis, 95.5 percent (772 of 808); those without cirrhosis, 95.6 percent (1,556 of 1,628); those with stage 3 chronic kidney disease, 96.7 percent (380 of 393); those with stage 4 or 5 chronic kidney disease, 96.3 percent (392 of 407); those coinfected with HIV, 98.6 percent (73 of 74); those without HIV, 95.5 percent (2,255 of 2,362); those with a history of alcohol abuse, 95.9 percent (1,412 of 1,473); those with no history of alcohol abuse, 95.1 percent (916 of 963); those with a history of drug abuse, 95.3 percent (1,251 of 1,313); and those with no history of drug abuse, 95.9 percent (1,077 of 1,123).
To read a press release about the study, click here.