Administering direct-acting antiviral therapy for
people who inject drugs at a syringe exchange site led to high sustained
response rates in a pilot study in New York City, researchers reported at the
recent Conference on Retroviruses and Opportunistic Infections (CROI) in
Seattle. Expanding treatment for this population could reduce hepatitis C virus
(HCV) transmission and ultimately help eliminate hepatitis C as a public health
threat.

The advent of direct-acting antiviral agents (DAAs)
used in interferon-free regimens has revolutionised treatment for chronic
hepatitis C. Most people can now be cured with well-tolerated oral therapy
given for 8 to 12 weeks. But the new therapies are not yet reaching everyone
who could benefit, especially marginalised populations such as people who
inject drugs.

Benjamin Eckhardt of New York University and colleagues evaluated
clinical outcomes from a prospective pilot programme offering hepatitis C
treatment to active injection drug users at a needle and syringe service site.

“The
introduction of direct acting antiviral agents for HCV has begun the discussion
about potential viral elimination,” the researchers noted as background.
“To maximize the population impact of DAAs on the HCV epidemic, more
people who inject drugs need to be cured of their infection.”

A total of 45
people enrolled in the programme, of whom 34 applied for HCV medications and 26
started therapy and were included in the analysis. Of the treated participants,
more than 90% were men, half were white, about 12% were black and more than 40%
were Latino/Hispanic. The mean age was 46 years and they had been injecting for
about 20 years on average. People with HIV co-infection were not included.

Nearly half
were homeless and all received health coverage through Medicaid (for low-income
people) or Medicare (for older people). About 60% were on opioid substitution
therapy, but they reported ongoing injection drug use with a range of 4 to 150
injections during the past month.

More than half
had HCV genotype 1, with about 20% each having genotypes 2 and 3. Most had not
been previously treated for hepatitis C. A majority had absent, mild or
moderate liver fibrosis, but three had advanced fibrosis (stage F3) and three
had compensated cirrhosis (stage F4). People with decompensated liver disease
were not treated on site and were instead referred to hepatology clinics.

Doctor visits,
blood draws for lab tests and medication distribution all occurred at the
syringe exchange site. About 40% used sofosbuvir/ledipasvir (Harvoni), 23% used sofosbuvir (Sovaldi) plus daclatasvir (Daklinza), 19% used sofosbuvir plus
ribavirin alone and the rest used other regimens; altogether all but one
received sofosbuvir-based therapy.

Among the 26
treated people, 22 (85%) achieved sustained virological response at 12 weeks
post-treatment (SVR12). Of the rest, one discontinued treatment due to adverse
events and one stopped early due to a lapse in insurance. Another person
stopped treatment at 6 weeks due to incarceration but was still cured. Two
people were found to have detectable HCV RNA within 4-6 weeks after completing
treatment. But they both started with genotype 1a and ended with genotype 3,
suggesting either reinfection or emergence of a second pre-existing strain that
was unresponsive to the regimens used. Both were retreated and achieved SVR12.

“People who inject drugs can be effectively treated for hepatitis C with
high rates of sustained virologic response,” the researchers concluded.
“Co-located treatment of hepatitis C within a harm reduction centre
(needle exchange facility) is a potential approach to engage people who inject
drugs in an accessible and de-stigmatised setting.” 


“The rates
of re-infection in this population, and the impact of HCV treatment at a
needle-syringe program on high risk behaviour and community-wide transmission
(cure-as-prevention) need further investigation,” they added.