Hepatitis C patients who use intravenous drugs were cured at a high rate by Merck & Co.’s experimental therapy, a study found, a result that could put pressure on U.S. states to more broadly cover new treatments for a group that’s at high risk of reinfection.
Many states require people with hepatitis C to prove that they abstain from drug use before getting covered through Medicaid, the U.S.’s state-run health program for the poor. In Merck’s study of 301 intravenous drug users, 95 percent of patients treated in the trial were cured of the virus, Merck said Saturday in a statement. In addition, 97 percent of patients took at least 95 percent of their hepatitis C drugs. Patients in the trial were also taking daily medicine to treat opioid addiction.
Intravenous drug users are the “hot core” of people with hepatitis C, according to Eliav Barr, head of infectious diseases at Merck, and few large studies have looked at the effectiveness of new oral therapies in treating them. A U.S. government study found that nearly half of young people who have ever injected narcotics like prescription painkillers or heroin have the virus, which spreads easily through needles.
“These are not-out-of control folks who are strung out on the street,” Barr said by phone on Wednesday. They’re much more emblematic of people who are IV drug users who are trying to kick the habit.”
State Medicaid programs have in many cases put restrictions on new hepatitis C treatments made by Gilead Sciences Inc. and AbbVie Inc. While the treatments are highly effective, governments have balked at list prices that can exceed $1,000 a day.
In a study published in June examining coverage policies in 42 Medicaid programs, about half required a period of drug abstinence before they’d cover treatment, and 64 percent required urine tests for drugs. Earlier this month the federal government warned states that they may be violating the law if they fail to provide people on Medicaid with the drugs they need for hepatitis C.
“This is going to be that ‘no excuses’ moment -- you cannot keep denying people with substance-abuse histories or even active substance abuse access to effective treatment,” Daniel Raymond, policy director for the advocacy group Harm Reduction Coalition, said by phone on Wednesday. “This kind of data is what we’ve been waiting for to say that processes that prohibit coverage of treatment for active drug users is de facto discriminatory.”
Most patients in the study were still using illegal drugs, with 59 percent using non-prescribed compounds like cocaine or amphetamines. The trial examined patients with three of the six major strains of hepatitis C and found the drug had high cure rates in all except for a type known as genotype 6, in which about 60 percent of patients were cured.
When the company included those who dropped out the study for reasons unrelated to the drug, or who were reinfected after initially having their virus cleared, the cure rate was 92 percent.
The trial may help Merck, whose therapy is still in development, eventually gain coverage of the drug with states and health insurers. The drugmaker has been chasing Gilead and AbbVie, in part by going after difficult-to-treat cases. Last month the drugmaker said an experimental combination therapy was effective against two strains of the virus after eight weeks, shorter than the usual 12-week course of treatment from current drugs.
By Doni Bloomfield - Bloomberg Business/Nov. 14, 2015