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Did OxyContin Reformulation Boost HCV Rates?

<ѻý class="mpt-content-deck">— Association suggests "unintended consequence" of abuse deterrent opioids
Last Updated February 5, 2019
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Reformulation of the potent opioid OxyContin in 2010 may have been linked with substantial increases in hepatitis C infections, researchers found.

Following the 2010 OxyContin reformulation, states with above-median initial misuse of OxyContin had a 222% increase in the rate of hepatitis C infections from 2004-2009 to 2011-2015, compared with a 75% increase in infection in states with below-median rates, reported David Powell, PhD, of the RAND Corporation in Arlington, Virginia, and colleagues.

Moreover, prior to the reformulation, there was nearly no difference in rates of hepatitis C infection between these groups of states, but after 2010, there were statistically significant differences, they wrote in .

"Injection drug use has consistently been identified as a predominant risk factor for hepatitis C, which has led some experts to wonder whether the opioid epidemic might be a driver of the recent rise in infections," the authors wrote.

Douglas Dieterich, MD, of the Icahn School of Medicine at Mount Sinai in New York City told ѻý that this is both important and timely information for clinicians who treat patients with hepatitis C.

"With prescription opiates, people can get addicted as rapidly as 5 days. But when patients simply can't get them anymore, they resort to heroin," said Dieterich, who is also director of the Institute of Liver Medicine. "We need to catch these patients and get them into rehab before they get hepatitis C [from injection drug use]."

Dieterich, who was not involved in the study, also cited the recent widely publicized case against OxyContin manufacturer, Purdue Pharma, explaining how while the company pushed the effectiveness of the drug, they never mentioned the addictive potential.

"The lawsuit is basically due to the marketing of the drug. They made billions from this," he noted.

Powell and colleagues stated that identifying a link between the reformulation of OxyContin (when it was made more difficult to crush or dissolve) and hepatitis C "would suggest unintended public health consequences associated with the broad adoption of abuse-deterrent pharmaceutical formulations of opioids."

They examined data from the CDC on the rate of acute new hepatitis C infections from 2004-2015, and used self-reported data from the National Survey on Drug Use and Health.

Overall, they found a decline of >40% in OxyContin misuse from the time of the 2010 reformulation until 2015, but there were also sharp increases in heroin-related mortality and hepatitis C infections.

"The coincidence of these trends suggests that factors driving the rise in heroin deaths may also be driving the rise in hepatitis C infections," the authors said.

Indeed, in the pre-reformulation period, they found that heroin mortality rates per 100,000 population were nearly identical in the groups of above-median and below-median initial OxyContin misuse states. They also found that the gap in hepatitis C infections between these two groups "widened more rapidly in 2011" and "continued to increase through 2013."

"This striking inflection point in the trend of hepatitis C infections for high-misuse states after 2010 mimics the inflection in heroin overdoses that occurred as a result of the reformulation," the authors wrote. "The unintended consequences of reformulation suggest that some caution is warranted in the implementation of other supply-side interventions that limit the supply of abusable prescription opioids."

An email from Purdue Pharma to ѻý said that heroin use was growing substantially before the reformulation, and that as heroin use went up, so did hepatitis C.

“The problem is that most researchers already come with a preconceived idea, that [abuse-deterrent formulations] ignited the epidemic, so they force the date of reformulation as the break point,” the company’s email stated, citing other spikes in heroin use in the third quarter of 2008, as well as the second and third quarters in 2009.

Dieterich added that this study emphasizes how important it is for clinicians to treat everyone with hepatitis C, adding "[treatment] is so easy and effective, there's no reason not to treat everybody."

Limitations to the data include potential understating of infection rates, that hepatitis C rates were missing for 20% of the sample due to non-reporting by states, and that misuse rates were based on self-reported data.

Disclosures

Powell disclosed support from the National Institute on Drug Abuse (NIDA) and a RAND Alumni Impact Award. A co-author disclosed support from NIDA.

Primary Source

Health Affairs

Powell D, et al "A transitioning epidemic -- How the opioid crisis is driving the rise in hepatitis C" Health Affairs 2019; DOI: 10.1377/hithaff.2018.05232.