SAN FRANCISCO – Preliminary data from a new study presented this week at The Liver Meeting® – held by the American Association for the Study of Liver Diseases – found that people who inject drugs who are infected with the hepatitis C virus have high rates of hepatitis C treatment adherence (completion of their treatment), and sustained virologic response. Based on these findings, researchers conclude these patients should be included in HCV treatment programs.
Hepatitis C virus, commonly called HCV, is a liver disease that ultimately can cause cirrhosis (scarring of the liver), liver cancer and liver failure. HCV is mainly contracted when a person comes in contact with an infected person’s blood.
People who inject drugs, such as opioids, are at high risk to acquire and transmit HCV, but many are excluded from HCV treatment programs due to concerns about their ability to follow their treatment plans. The ANCHOR Study, conducted by researchers at the Institute of Human Virology at the University of Maryland, evaluated HCV treatment in patients who have chronic HCV, opioid use disorder and ongoing injection drug use. They looked at rates of treatment adherence, treatment completion and sustained virologic response (commonly called SVR) as benchmarks. This is an ongoing study, and data will be updated in the future.
“The ANCHOR study was developed in an attempt to understand if people who inject drugs can be effectively treated with direct-acting antivirals,” explains Elana Rosenthal, MD, co-director, DC PFAP Hepatitis Clinical Research Program, University of Maryland, and the study’s co-author. “Many insurance companies impose restrictions requiring treatment of or abstinence from drugs and alcohol prior to initiation of HCV medication. We wanted to specifically evaluate treatment of the highest risk population, people with ongoing injection drug use, to evaluate if they could be cured with standard treatment using direct-acting antivirals.”
Beyond these restrictions, insurance companies often deny access to HCV treatment for people who inject drugs based on an assumption that they will not follow their treatment plans, says Dr. Rosenthal. “However, this assumption is based on stigma and not medical science. Therefore, we wanted to evaluate if people who inject drugs could have sufficient adherence to HCV treatment to achieve cure.”
Of the 100 participants enrolled in the study, 76 percent were male, 93 percent were black, and 51 percent were unstably housed. Their median age was 57 years. At the study screening, 58 percent of the participants reported they injected opioids at least daily.
Patients received HCV treatment with sofosbuvir/velpatasvir over 12 weeks. Medication was dispensed monthly in 28-pill bottles. Sixty out of 66 patients who reached week 24 of their treatment received a second bottle of medication before running out, and 58 patients received a third bottle of medication before running out. At the fourth week of HCV treatment, 62 patients had their HCV viral load checked, and 59 had a HCV viral load of less than 200 IU/mL.
Two patients received four weeks of treatment, two patients received 8 weeks of treatment, three received between 8 and 12 weeks of treatment, and 59 received 12 weeks of treatment. Of the 59 patients who completed 12 weeks of treatment, 28 finished treatment one to seven days after the anticipated end date; nine finished between eight and 14 days late; and nine patients finished more than 14 days late.
Of the 58 patients who attended an office visit at week 24 of their treatment, 52 achieved SVR (which is marked by no detectable HCV in the blood for 12 or more weeks), giving an overall cure rate of 89.7 percent. This high rate of cure was significantly associated with having an HCV viral load of less than 200 at week four, and with taking 12 weeks of treatment. The researchers also found that finishing treatment late did not impact SVR, even in those completing treatment more than 14 days late. Preliminary data from the study indicates that people who inject drugs who also have HCV and are continuing injection drug use have high rates of adherence and completion in their therapy programs and achieve SVR – even with imperfect adherence.
“Our data demonstrate that people who inject drugs can achieve SVR at comparable rates to non-drug using populations, even if adherence is imperfect,” explains Dr. Rosenthal of the study’s findings. “Therefore, there is no justification for excluding people who inject drugs from being treated. In fact, people who inject drugs should represent a unique high-priority population, because injection drug use remains the primary reason for ongoing HCV transmission in the U.S. Therefore, treatment of people who inject drugs will help prevent new cases of HCV.”
Editor’s note: This press release contains updated data that is not reflected in the published abstract but will be presented at The Liver Meeting®.
Dr. Rosenthal will present these findings at AASLD’s press conference in Room 312-314 at the George R. Moscone Convention Center in San Francisco on Saturday, Nov. 10 from 4 – 5:30 PM. The study entitled “High Svr in PWID with HCV Despite Imperfect Medication Adherence: Data from the Anchor Study,” will be presented on Monday, November 12 at 8:00 AM in Hall D. The corresponding abstract (number 0018) can be found in the journal, HEPATOLOGY.