Illegal drug users should not be denied treatment for Hepatitis C, say UCSF researchers

By Maureen McInaney

UCSF researchers are recommending that illicit drug users should be eligible to
receive treatment for the hepatitis C virus.  The recommendation, published in
the July 19 issue of The New England Journal of Medicine (NEJM), differs from
the 1997 National Institutes of Health (NIH) Consensus Statement on the
Management of Hepatitis C. This recommends that people using illicit drugs be
denied treatment for hepatitis C until they have stopped drug use for at least
six months.

The researchers noted that drug users are the source of most hepatitis C
transmission in the United States. Hepatitis C is caused by a virus that is
readily transmitted through contaminated needles and syringes.

“Controlling hepatitis C will require providing treatment to people who use
illegal drugs. We believe that when treatment is guided by evidence, tolerance,
and compassion, this can be done,” said Brian R. Edlin, MD, director of Urban
Health Study in the UCSF Department of Family and Community Medicine and the
Institute for Health Policy Studies. Edlin is lead author of the article.

The article was authored by seven USCF scientists but reflects the consensus of
a group of 38 national and international experts in AIDS, liver disease,
substance abuse, and health policy. The members of this group, called the
Hepatitis C Illicit Drug User Treatment Policy Group, are listed at the end of
this news release.

“Illicit drug users are a stigmatized group with many health problems. A
recommendation to withhold medical treatment from them raises questions about
fairness and discrimination,” the authors said.

The researchers examined the rationale for excluding drug users from treatment
for infection with HCV, the hepatitis C virus, in light of clinical data,
ethical guidelines, and accepted medical and public health practices. Based on
this examination, they propose a less restrictive policy.

Treatment decisions for illicit drug-using patients should be based on individualized risk-benefit assessment, according to UCSF researchers. They explained that the patient and physician should make the decision together after a thorough discussion of the need for adherence to the treatment regimen and the risks of adverse effects and reinfection. The patient’s willingness to stay on medication, mental health and risk of depression, access to safe injection equipment, and knowledge of safe injection practices should also be considered, they said.

Arguments against allowing drug users to be treated for hepatitis C include a
concern that they will not finish the treatment, a preference that they receive
substance abuse treatment first, and the fear that they will get infected with
HCV again. 

Regarding the first issue, “poor adherence to medication is common when we
treat hypertension, asthma, and diabetes,” said Edlin. “If poor adherence were
a reason to withhold treatment, most medical conditions would go untreated. The
fact is that when treatment strategies take into account patients’ life
circumstances, adherence by drug users to medical interventions is as good as
in any group of patients-and often very good.”

The desire that patients stop using drugs is commendable, said the UCSF
researchers, but unfortunately many patients are not ready or able to stop
using drugs, and for those who are, substance abuse treatment programs are
often too expensive or just don’t have room. Although all patients using drugs
are now told they cannot be treated for HCV, delaying HCV treatment only makes
sense when there is a plan for substance abuse treatment.

“For patients for whom there is no such plan, deferring therapy amounts to a
tacit decision to withhold it indefinitely. A policy of deferring HCV treatment
indefinitely in patients who do not have access to substance abuse treatment
effectively abandons those most effected by the HCV epidemic,” said the

Some experts argue that because injection drug users can be reinfected with the
hepatitis C virus, there is no point in treating them for the virus until they
stop using drugs. “But persons who inject drugs while receiving treatment for
HCV can avoid reinfection by using a new sterile syringe for each injection and
by not sharing their injection equipment with other users,” said the
researchers. Syringe-exchange programs exist in more than 120 cities in the
U.S., and some states allow syringes to be bought in drug stores without a
prescription. “Experience has shown that when they are given access to sterile
syringes, injection drug users readily make use of them, reducing their risk
behavior and disease transmission,” Edlin said.

Nor are patients whose behaviors could cause recurrence of a condition
generally denied treatment in other settings, the researchers noted. Smokers
are not denied coronary artery bypass surgery or treatment for emphysema,
chronic drinkers are not denied treatment for gastrointestinal problems, and
commercial sex workers and others with high-risk sex practices are not denied
treatment for sexually transmitted infections because of the risk of
reinfection. In fact, they are specifically targeted for treatment to interrupt
disease transmission, according to Edlin.

“The difficulties of caring for drug users should not be underestimated. Users
engage in behaviors that society defines as illegal. They may fail to keep
appointments or take medications as directed. Sensing the disapproval of their
providers, they may resist ongoing health care relationships. They may be
unwilling to plan ahead and make changes in their lives,” said Edlin.
“Withholding treatment, researchers have found, is a common response to the
frustration doctors understandably feel. But drug users are human beings who
need treatment.”

“Physicians treating patients with hepatitis should take a page from AIDS
doctors, who have learned many lessons from caring for disenfranchised groups
for two decades. There’s no need to reinvent the wheel. HCV infection is
considerably easier to treat than HIV infection, yet AIDS doctors have found
ways of providing HIV therapy to active drug users. Successful programs adopt a
respectful approach to substance abusers, understand the medical and behavioral
cycle of addition, and refrain from moralistic judgments.”

A new study published in the June issue of the medical journal Hepatology
provides evidence to support the UCSF researchers’ view. The article reports on
50 patients in Germany who were drug users with HCV infection who were treated
for both substance abuse and HCV at the same time. Although 80 percent of the
patients relapsed and went back to using drugs during the study, the overall
sustained response rate to the HCV treatment was 36% -which is similar to that
seen in the best of clinical trials done with non-drug-using patients. This
study shows that it is possible to treat drug users with HCV successfully even
if they continue to use drugs, if the circumstances are right. The physicians
treating the patients in the study were experts in both liver diseases and
substance abuse medicine, and the patients were allowed to continue receiving
their treatment for HCV regardless of whether they used drugs.

The editors of NEJM solicited a response to the article by UCSF researchers
from Gary L. Davis, M.D., director of hepatobiliary diseases, University of
Florida, Gainsville and one of the liver disease experts who participated in
the consensus conference at which the NIH guidelines were written. In his
reply, Davis, while defending the guidelines generally, discussed circumstances
under which some drug users can be successfully treated for HCV infection.
Davis recommended collaboration between physicians with expertise in treating
hepatitis and substance abuse to maximize benefit to the patient.

NOTE: The Hepatitis C Illicit Drug User Treatment Policy Group is comprised of
38 national and international experts in AID, liver disease, substance abuse
and health policy.