The finding refutes the argument that many health plans use to deny treatment to this population, said Elana Rosenthal, MD, from the hepatitis clinical research program at the University of Maryland in Baltimore.
“Active and ongoing drug use should not be used as a justification to deny treatment to patients,” she told Medscape Medical News.
“Even if they have challenging demographic characteristics, many of these patients can be successfully treated,” she said here at The Liver Meeting 2018.
Direct-acting antiviral drugs have transformed the care of people with hepatitis C. People who could not have been effectively treated in past decades are being cured, raising the possibility that the virus will one day be eradicated worldwide, a goal of the World Health Organization (WHO).
However, direct-acting antivirals are relatively expensive, and many health plans, including Medicaid in some states, deny them to people who inject drugs because of concerns that they won’t take the pills on schedule.
“Beyond insurance restrictions, a lot of providers continue to be reticent to treat these patients because they don’t feel they have the tools to understand who would be adherent to treatment and who would be likely to be cured,” said Rosenthal.
To get some answers, Rosenthal and her colleagues recruited participants who had hepatitis C from a needle-exchange program.
No one was excluded because of concerns about adherence. “We really wanted to have a population of all comers, not biased by the perspective of any provider,” Rosenthal explained.
Of the 100 people who enrolled in the study, 76 were male, 93 were black, 92 had been incarcerated, and 51 were unstably housed. Median age was 57 years. At initial screening, 58 reported that they injected opioids at least daily, 29 reported sharing intravenous drug equipment in the previous 3 months, and 40 reported hazardous drinking.
Study participants received a combination of sofosbuvir and velpatasvir dispensed in 28-pill bottles.
At week 4, 59 of the 62 patients tested had a hepatitis C viral load below 200 IU/mL.
Of the 59 patients who completed 12 weeks of treatment, 28 finished treatment 1 to 7 days after the anticipated end date, nine finished 8 to 14 days late, and nine finished more than 14 days late.
Finishing treatment late did not affect sustained virologic response, even in patients completing treatment more than 14 days late.
|Table. Length of Treatment Completed|
|Length of Treatment||Number of Patients|
By week 24, 60 had received a second bottle of medication, indicating that they had finished the first bottle, and 58 patients had received a third bottle.
Of the 58 patients who attended an office visit at week 24 of their treatment, 52 had achieved a sustained virologic response, defined as undetectable hepatitis C virus in the blood for 12 weeks, for an overall cure rate of 89.7%.
This high rate of cure was significantly associated with having viral load of below 200 IU/mL at week 4 and with the completion of 12 weeks of treatment.
Occasionally patients decide to put off treatment until they know they’ll be able to follow through, she said. For example, they might wait until after a court date in case they are incarcerated and have to suspend treatment.
My experience is that people who inject drugs desperately want treatment.
“There’s this lore that people who inject drugs don’t care about their health,” she said. “That has not been my experience. My experience is that people who inject drugs desperately want treatment. But if you make them feel like they’re not worthy of treatment, you’re going to lose them.”
Denying patients treatment can lead to transmission of the virus to other people, said Jordan Feld, MD, from the Francis Family Liver Clinic at the University of Toronto, who moderated a news conference during which Rosenthal presented the study findings.
“Every study that has looked at cost-effectiveness has shown that the most cost-effective group to treat is people with cirrhosis” because of the societal benefit of transmission reduction, he told Medscape Medical News. “The second-most cost-effective group to treat is people who inject drugs.”
“If you looked at the science, we would be treating these people,” Feld pointed out. But instead, these people are being denied treatment because of what is considered a moral failing.
“If the United States is serious about meeting WHO elimination targets, these restrictions have to go,” he said.
Rosenthal has disclosed no relevant financial relationships. Feld reports relationships with AbbVie, Gilead, Merck, Enanta, and ContraVir.