NEWS

Hepatitis C: Delaware’s hidden epidemic

Jen Rini
The News Journal

Delaware’s skyrocketing number of heroin users face a hidden epidemic in hepatitis C, and many can’t get the medicine they need to get well.

A 12-week regimen for the most effective pharmaceutical treatments, Sovaldi and Harvoni, can cost up to $94,500.

Patients must jump through hoops to secure the costly medicines through their private or government insurance plans, allowing the infection to slowly destroy their livers.

Hepatitis C, a blood-borne disease, is most easily spread through intravenous drug use. It’s a viral infection with few early symptoms, and danger signs may not appear for decades. Ultimately, patients endure liver scarring, liver cancer or total failure of the organ. If not treated, hepatitis C can be lethal.

But the need to get high often comes before getting treatment – for the addiction or the hepatitis C.

“In those moments of desperation and there’s only one needle and two of you ... you just pray for the best,” said John Dooling, a wellness advocate who works with hepatitis C patients at Brandywine Counseling & Community Services in Wilmington.

The wave of heroin addiction sweeping America also is driving an explosion of hepatitis C cases – jumping over 151 percent from 2010 to 2013. But Delaware is one of seven states – and the only state in the Mid-Atlantic – that does not consistently report case numbers back to the Centers for Disease Control and Prevention since 2009.

Based on the limited testing recorded to the state Division of Public Health, Delaware has an estimated 1,200 chronic cases a year, but state officials acknowledge that number is under-reported.

Opiate addiction providers say the numbers testing positive for hepatitis C are overwhelming.

Lamont Baker, site coordinator for Connections’ outpatient substance abuse clinic in Newark, estimates that 500 people walk through the doors each day, 300 of them intravenous drug users. And 85 percent of those drug users have hepatitis C, he said.

“I think this is the silent threat,” said Debbie Pringle, site director for Connections Community Support Programs in Millsboro. “No one is really paying too much attention to it.”

Pringle’s team tests 15 patients per week for hepatitis C, and at least nine are confirmed to have the disease.

In Wilmington, Dooling said, “If I test 100 people, 90 come up positive. It’s really an epidemic that’s kind of getting swept under the rug.”

John Dooling, who contracted hepatitis C from IV needles, helps people diagnosed with HepC as a counselor at Brandywine Counseling & Community Services in Wilmington.

All Delaware medical professionals who order medical tests must report positive hepatitis C results to the Public Health Division. But there’s nothing in state law requiring people being treated for opiate addiction to be tested for hepatitis C.

And state officials say they are not sure if mandatory testing is necessary.

“This epidemic was driven by illicit drug use. It’s not an epidemic in the general population,” said Dr. Martin Luta, director of the Delaware Division of Public Health’s viral hepatitis program.

“When you over-test, then you may stretch the system. We need to figure out if it is worth testing everybody.”

Based on claims data from Medicaid through June 30, 6,476 hepatitis C tests cost the state $234,954.

Rita Landgraf, secretary for the Delaware Department of Health and Social Services, said the state’s primary focus is to get addicts into treatment for opiate abuse.

The first line of defense must be to stop the deaths, she said. Seventy-eight people have died in Delaware from suspected overdoses as of July.

Next month, the state is opening a new detox center in Harrington and has invested $4.45 million in this year’s state budget to pay for an increase in treatment beds, Landgraf said.

“We are first just focused on how do we build capacity,” she said.

Victor is a 54-year-old New Castle man who has waited months to learn if his insurance carrier, Highmark Blue Cross Blue Shield of Delaware, will approve the hepatitis C treatment plan recommended by his doctor.

He asked that his full name not be used because he is uncomfortable with people knowing he contracted the disease from intravenous drug use – a decision that could cut short his life.

Private insurance companies set different coverage requirements for the specialty medication to treat hepatitis C, and Medicaid has stringent guidelines to approve it.

Victor has significant liver scarring and inflammation from a hepatitis C infection he contracted 25 years ago during a period of drug experimentation.

“I was in my 30s when it finally sunk in. Like, wow, I got a dirty disease,” Victor said.

“I can’t even get married because I have to wait until this is over. This is the biggest thing in my life now, taking care of my HepC.”

Weighing about 4 pounds, the liver filters nutrients in the body and breaks down fats, proteins and carbohydrates as well as toxic substances in the blood such as alcohol. When a liver fails, those toxic substances are not filtered properly, and the body shuts down.

Victor’s organ damage was rated as stage 2 on a severity scale with stage 4 being the highest. His disease will likely cause cirrhosis of the liver.

Fatigue is the only major symptom at this point, but Victor is terrified of what may come next. Telltale signs include abdominal pain, joint pain, a loss of appetite, jaundice, dark urine and clay-colored stool.

Victor has seen old friends die from the disease, and his cousin recently died after hepatitis C caused liver cancer.

“All of I can think of is, ‘Oh man, if I don’t get this treatment, I’m done,’ ” Victor said. “What do they want me to do, die?”

Victor’s doctor, Dr. Michael Brooks, a gastroenterologist with GI Specialists of Delaware, estimates that at least 20 percent of the patients he sees each year want hepatitis C treatment and counseling. But most of his patients are not approved for medication until their livers are so deteriorated that drugs won’t make much of a difference.

“We have a cure, but yet you have to wait until you have cirrhosis of the liver to get treated,” Brooks said. “I look them in the eyes and say, ‘Here’s a pill that can cure you in eight to 12 weeks, but your insurance is not going to pay for treatment.’ ”

Even though these medications clear the hepatitis C virus, it’s possible to contract it again if a person comes in contact with another’s infected blood. There is no vaccine.

“Even a single incidence puts someone at risk,” said Luta, director of the Delaware Division of Public Health’s viral hepatitis program.

Adam Suib said his hepatitis C diagnosis may be the incentive he needs to stay off of heroin for life.

“If I don’t get treated in five years, I could develop cirrhosis,” the 24-year-old said.

Suib was tested for hepatitis C when he was admitted into rehab at Gateway Foundation in Delaware City four years ago. He later learned that his liver enzyme levels were extremely high and that elevated enzyme levels signify inflammation or damage to the liver cells – typically caused by drinking alcohol or obesity.

Adam Suib said his hepatitis C diagnosis may be the incentive he needs to stay off heroin for life.

But Suib’s hepatitis C stemmed from intravenous drug use. When diagnosed, Suib said, he was determined to avoid heroin, but began using again after leaving rehab.

Today, he has been clean for 13 months and insists that heroin will never course through his veins again.

He understands that if he’s fortunate enough to get drugs from Medicaid and clear the virus from his body, it could return should he relapse and again share a needle. He has Medicaid, but has yet to work with a doctor on a hepatitis C treatment application.

Recreational drug use started for Suib at 13 with marijuana, he said, as a coping mechanism for mental and physical abuse at home. He moved on to crack cocaine, and finally heroin.

After work these days, Suib might go to a bar and unwind with a drink, but said he never gets drunk. And he doesn’t feel guilty about doing so – in spite of pressure to quit drinking from peers in recovery, who believe alcohol could lead to a heroin relapse.

“Sometimes I want to sit back and have a beer,” Suib said. “I never, ever think about using drugs.”

Hepatitis C can be difficult to treat because some of the six strains are immune to certain drugs. The most popular pharmaceutical treatments, Sovaldi and Harvoni, are known as “direct-acting” and have over 90 percent success rates in clinical trials.

Initially, without rebates, it costs $84,000 for a 12-week treatment of Sovaldi. Gilead, the company that manufactures Sovaldi and Harvoni, said a one-month supply of Harvoni costs $31,500. The total 12-week treatment is $94,500 – but patients with a less severe condition may need the medication for only eight weeks.

Given the high price and potential for inappropriate usage, the Medicaid division has stringent requirements to preauthorize medication, says state Medicaid Director Steve Groff.

Groff understands that the medication is highly effective, but points out that state “resources are limited.” In 2014, the division paid $2,462,293 for hepatitis C drugs – $1,626,899 for Sovaldi alone.

“If people can be effectively treated with alternative therapies, then we need to triage those with the greatest need to the top of the list,” he said. “We are doing our best to target and make sure those who need it get it, and to review the policies. If we find that modification is needed down the road, we will certainly take that step.”

Medicaid’s basic preauthorization guidelines say medication can be approved only if it treats the person’s hepatitis C genotype, a virus classification based on genetic material.

People must be clean from drugs and alcohol for at least three months before therapy.

Yet, in order for the direct-acting medications to be approved, a Medicaid patient must be diagnosed with late-stage cirrhosis or liver scarring. To approve a medication that is not specifically recommended for the patient, the division must receive documentation from a doctor that a prior therapy was unsuccessful.

Before the federal Food and Drug Administration approved Sovaldi, Harvoni and other treatments, the standard hepatitis C therapy involved up to a yearlong regime of the drugs pegylated interferon and ribavirin that carried debilitating side effects – severe flu-like symptoms, skin rash, depression, anxiety and diarrhea.

In 2013, preauthorization of combination treatments with interferon and ribavirin were submitted to state Medicaid 36 times, and all were approved.

By 2014, however, 184 preauthorization requests were submitted to the state – and only 44 were approved.

Of those numbers, 108 people applied for a Sovaldi treatment regime, but 89 were denied. Twenty-one people sought Harvoni, and 19 were denied. Twenty-three patients were approved for the drugs Incivek, Victrelis or Olysio. Incivek and Victrelis are used commonly with interferon and ribavirin; Olysio with just ribavirin.

Matt Stehl, spokesman for Highmark Blue Cross Blue Shield of Delaware said from 2013 to 2014 the company saw a 30 percent increase in specialty pharmacy usage, partially driven by new hepatitis C drugs.

“Highmark has implemented clinical programs to help ensure that these valuable treatments are available to the right patient at the right time,” Stehl stated.

Highmark offers one of two Medicaid plans in the state as well as a variety of private insurance plans. It follows Medicaid authorization conditions set by the state. In the company’s first six months as a Medicaid provider, it has not seen a high utilization rate of hepatitis C medicine, Stehl said.

United Healthcare, the other insurance company that offers a Medicaid plan for Delaware, also follows the state’s criteria for administering hepatitis C drugs, said spokeswoman Mary McElrath-Jones.

Pringle, the Connections director in Millsboro, said it’s wrong to prescribe drugs to some people with hepatitis C while allowing others to suffer, and potentially die, because they don’t meet an insurance guideline.

“There’s no reason to treat a slice of the pie and let the rest of it mold.”

Mike Barbieri, incoming state director for the Division of Substance Abuse and Mental Health, acknowledged that uneven coverage is a problem.

“We have to face it, and we have to find ways to afford the intervention,” he said.

Dooling and his fiancée Leslie Palladino both work at Brandywine Counseling in Wilmington, and both have hepatitis C. They feel lucky that their Aetna private insurance plan covers the Harvoni treatment plan prescribed by their physician.

Dooling will begin his treatment Thursday. Palladino is approaching her fourth week on Harvoni.

She takes one pill at 1:30 p.m. every day. The worst side effect she feels is nausea and occasional migraine headaches, she said.

Dooling endured the side effects of interferon in an earlier attempt to kill the virus living within him, but both are happy to be on the newly approved drugs.

Leslie Palladino, 25, who has hepatitis C, has been taking Harvoni for nearly four weeks. A one-month supply of the drug costs $31,500. Her Aetna private insurance plan covers the treatment plan.

“This is 10 times better,” said Palladino, 25. Fatigue is the worst side effect, but it lasts only a short time, she said.

Though Palladino knew there was always a possibility she’d test positive for hepatitis C because of her intravenous drug use, she was devastated when diagnosed three years ago.

Dooling was more angry than devastated. And his diagnosis did nothing to deter him from using heroin.

His father and mother both drank and did drugs, and he started smoking marijuana and drinking at age 15 after being kicked out of school. Ultimately, Dooling turned to heroin and bounced in and out of rehab. After being busted for robbing a bank, he spent five years in prison.

None of that quenched his thirst for opiates. But after overdosing on heroin – and losing consciousness for seven minutes – Dooling vowed to never shoot dope again.

“That was the last bottom I needed,” he said. “This last time I just surrendered. I knew it’s not what I wanted anymore. I didn’t want to be shackled by heroin.”

Dooling and Palladino celebrated their third anniversary of being clean this year, and are planning to someday get married and enjoy a quiet lifestyle with their caramel-eyed American pit bull terrier, Omega.

The hepatitis C virus is hardy and can survive outside the body at room temperature for up to three weeks. It does not spread like the common cold, or by sharing forks or knives, breastfeeding, kissing, holding hands, coughing or sneezing. It cannot be spread through food or water.

Sharing personal items that could have come into contact with another person’s infected blood – razors and toothbrushes, for example – could expose one to risk. Poor infection-control practices at tattoo or piercing facilities also can transmit hepatitis C, but it is extremely rare.

Hepatitis C is unlikely to be spread through sexual contact, although one could contract the disease that way if a person has multiple partners and engages in rough sex where blood is transmitted.

Melissa Gryzbowski, 31, is worried that she may have gotten the disease from her infected ex. She just went on a 90-day heroin bender, frequently sharing needles with a new boyfriend and panicked that she had it and it could be spreading.

“I’m scared,” said Gryzbowski, who showed up at Connections’ Newark outpatient treatment center last Thursday eager to be tested, and to secure methadone to curb her craving for heroin.

Melissa Grzybowski, 31, of New Castle, worries she might have hepatitis C. She took a blood test at a Connections Community Support Programs clinic in Newark to find out.

To decrease the spread of HIV and hepatitis C through intravenous drug use, many states have open needle exchange programs that allow drug users to turn in their used needles or syringes and receive clean ones.

Delaware has operated an exchange, run by the state Division of Public Health and Brandywine Counseling, since 2007, but it serves people only in Wilmington. In those eight years, 357,382 needles have been exchanged.

The route the staff travels includes the Southbridge section near C and Townsend streets and the Eastside, off Eighth and Church streets.

People can trade in 50 needles at a time, said Julie Hammersley, senior outreach supervisor of the program for Brandywine. But heroin use is exploding statewide, and many addicts don’t make it to Wilmington to swap out dirty needles.

“It does make sense that we try to make that [needle exchange] statewide,” said Landgraf, secretary for Delaware’s Health Department. “I think it’s something that we should look at.”

As a teenager Gryzbowski said she dreamed of becoming a marine biologist. She never envisioned herself as a “junkie.”

She said she got into drugs at 19 when she became hooked on the Percocets prescribed to manage the pain she suffered after a car crash. When her prescription was done, heroin was a cheaper next step, she said.

Today she said she’s ready to get clean. She hopes to some day start life over with her three children – ages 9, 10 and 15.

“I want to get a house and get my children back,” Gryzbowski said.

Jen Rini can be reached at (302) 324-2386 or jrini@delawareonline.com. Follow @JenRini on Twitter.