The numbers climbed, federal investigators arrived, and on July 19, with at least 30 people having tested positive, prosecutors announced they had identified the source of the infections: a former technician at the hospital.
Prosecutors allege that 33-year-old David Kwiatkowski stole syringes of a powerful anesthetic called fentanyl from the cardiac catheterization lab, injected himself, and then returned the tainted needles, which were reused on patients. Kwiatkowski worked in seven other states before New Hampshire, raising the specter that he infected others — possibly hundreds across the country, according to prosecutors.
For the patients in Exeter, the revelations heaped a new health problem onto old ones. Many had underlying conditions that had brought them to Exeter Hospital. Some had primary care doctors affiliated with the hospital — a place from which they no longer wished to receive care.
That led some two dozen of them to the “Hepatitis C Patient Information Night” in the conference room at the Georgian-styled Exeter Inn.
The evening was billed by its attorney-organizer, Domenic Paolini, as a chance to learn about advances in hepatitis C treatment and to hear attorneys explain the legal landscape for medical malpractice in New Hampshire and possible settlement options.
Paolini organized the evening under the umbrella of the Patients Speak, a not-for-profit advocacy group that he formed with Elenore Casey Crane, a public relations consultant, after the outbreak. The group held an initial meeting in June, at which Chung also spoke, assuring patients that hepatitis C was not a death sentence and could be treated.
On this August evening, sandwiched between Paolini and another medical malpractice lawyer, Chung waited his turn to make a pitch — his latest foray in the fierce race to conquer hepatitis C, which affects an estimated 3.2 million people in the United States.
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The standard treatment for hepatitis C for years has been weekly injections with interferon, a regimen that, on average, cures fewer than half of patients with the most common form of the virus and sometimes spawns flu-like side effects.
The terrain shifted dramatically last year when the FDA approved two new drugs, Vertex Pharmaceuticals’s telaprevir and Merck & Co.’s boceprevir, which, when taken in combination with interferon, increased cure rates to roughly 80 percent and 65 percent, respectively. Chung was an investigator for trials of both drugs.
Now, Chung is seeking to be at the forefront of the next frontier: identifying a combination of oral medications that would not require interferon.
“We are on the threshold of a treatment revolution,” Chung wrote in the New England Journal of Medicine in January.
But in late August, Bristol-Myers Squibb announced it was discontinuing development of an oral hepatitis C drug after nine patients in a clinical trial were hospitalized and one died. The FDA that month put a hold on trials of a drug in the same class being tested by Idenix Pharmaceuticals.
The oral combination that Chung hopes to test in Exeter is made by Gilead Sciences, according to Dr. Elizabeth Hohmann, director of Partners Human Research Committee, charged with overseeing Mass. General’s clinical trials. Chung, who said he does not have a financial stake in the research, said the combination had already been tested in phase one trials to establish safety, phase two trials to assess efficacy, and has entered phase three trials, often the last step before submission for FDA approval.
The Exeter patients, who would be in a phase 2 trial, represent a singular research opportunity because they contracted the disease in the same recent time span, potentially providing a window into how the infection plays out in its early stages — a vital piece of knowledge in tackling the disease.
At the Exeter Inn, Chung introduced that drug combination as a “strand of hope.”
“We were able to approach a company that was developing these newfangled drugs,” he told the audience. “And this isn’t just any set of compounds. This is a set of compounds that have already been in trials . . . that have demonstrated not just safety, but as well, effectiveness against hepatitis C. And effectiveness here means not only the clearance of virus during the administration of the medications but a permanent clearance.
“You can essentially equate that with a cure, a cure of the infection.” These drugs, he said, were accomplishing in as little as three months what an interferon-based regimen took six months or longer to achieve. The new drugs were doing so “in a manner that does not disrupt or interrupt quality of life to anywhere near the extent that interferon might,” Chung said.Continued...