We have had the ability to cure many people of hepatitis C (HCV) -- a common viral infection of the liver -- since 2011. These new drugs are effective at curing most strains of the virus and have far fewer side effects than earlier generations of treatment. Despite these major scientific advances, however, hepatitis C rates remain high, particularly among those who are also living with HIV, as well as among people in prison and people using drugs, particularly drugs taken by injection.
Our lack of progress toward eliminating hepatitis lies in a poor screening and surveillance system, the continuing opioid epidemic, and the high cost of the cures -- which has led many insurers, most notably Medicaid, to limit treatment to those who are already suffering some of the long-term consequences of this infection.
Risk of HCV Infection
Hepatitis is an inflammation of the liver that can lead to decreased liver function. Hepatitis can be caused by toxins, including alcohol and certain medications, or it can be caused by a virus. HCV is the virus that causes hepatitis C, or hep C. It is one of the most common hepatitis viruses.
HCV is transmitted through blood-to-blood contact. Before we had a screening test for hep C in 1992, most people got infected through blood transfusions. This explains why baby boomers, those born between 1945 and 1965, are five times more likely to have the virus.
Today, most people with the virus get infected by sharing needles or other equipment for injecting drugs. Recent research has shown that the growing opioid epidemic is driving up rates of hep C infection, especially among young people. In addition, the prison population is at high risk for infection because of the high number of injection drug users who enter correctional facilities who are already living with hep C. Inside prisons, hep C is transmitted through injection drug use and unsafe practices for tattoos and piercings. It is estimated that one in three people in U.S. jails and prisons have HCV.
Hep C can be transmitted through sexual activity; however, this is rare and most likely to happen if a person is already living with HIV or another sexually transmitted infection. The Centers for Disease Control and Prevention (CDC) estimates that 25% of people living with HIV also have HCV.
Other vulnerable populations include health care workers who are exposed to a patient's blood through a needle stick, and babies born to mothers with the virus.
Acute hep C is the liver inflammation that happens within the first six months of infection. Though only 3,186 cases of hep C were reported in 2017, the CDC estimates that there were upward of 44,000 infections that year. Some people can clear their body of the virus without medical intervention, but between 75% and 85% of people who become infected will develop chronic hep C. If left untreated, chronic hep C can cause liver damage, cirrhosis (scarring of the liver), liver cancer, and death.
HCV Symptoms and Screening
Acute infection often has no symptoms or has symptoms that are mild and/or mistaken for other common illnesses. And chronic infection occurs over the course of years or even decades, again with symptoms -- such as fatigue and depression -- that are often attributed to a different cause. In fact, it is estimated that 50% of the 3.9 million adults who are living with HCV in the U.S. do not know it.
The CDC recommends that all adults born between 1945 and 1965, anyone who got clotting factor before 1987, and anyone who received a blood transfusion or organ transplant before 1992 be screened at least once. The agency also recommends screening for long-term hemodialysis patients, as well as anyone who has ever shared needles for drug use (even if it was only once), gotten an unregulated tattoo, or has HIV. In addition, the U.S. Preventive Services Task Force recommends that everyone in the prison population be tested for HCV.
Unfortunately, we do not have a robust screening and surveillance system in place to track hepatitis C infections the way we do for HIV. In 2017, only 14 states received money from the CDC for HCV surveillance (before that, it was only five). And only 22 states require HCV testing for those coming into prison. Moreover, a recent survey of health care providers found that fewer than 30% are following the CDC's screening recommendations.
Outcomes and HCV Treatment
There is no treatment recommended for acute hep C infection; however, patients should be monitored to see if the infection becomes chronic. Chronic hepatitis C can cause liver cancer or cirrhosis (scarring of the liver) and is the most common reason for liver transplants in this country. The CDC estimates that of every 100 people infected with HCV, 75 to 85 will develop chronic infection, and 10 to 20 will develop cirrhosis within 20 or 30 years. Of 100 people who have hepatitis C and have developed cirrhosis, between three and six will develop liver failure each year and between one and five will develop liver cancer each year. There were 18,153 deaths related to HCV reported to the CDC in 2016, but this is likely an underestimate.
Treatment for chronic hep C has come a long way in recent years. Until the 1990s, there was no cure at all. Then a series of treatments were developed using interferon-based regimens. These treatments were long -- some regimens required three injections per week for 48 weeks -- and had lots of side effects, including rashes, fever, and nausea. Fewer than 10% of patients cleared the virus with the original treatment protocols, but improvements over the next two decades meant that by 2011 there was a 40% to 80% chance a patient would clear the virus after a round of treatment that included 24 or 48 weekly injections. However, interferon was not recommended for patients with autoimmune diseases or decompensated liver disease, which excluded many of those who needed it the most.
A whole new class of medication, called direct-acting antivirals (DAA), was introduced in 2011. The first two drugs to be introduced -- boceprevir and telaprevir -- improved the outcomes dramatically but still required patients to take interferon. About 70% of patients achieved sustained virologic response (SVR) on the first generation of DAAs.
Then in 2014, Gilead Sciences introduced ledipasvir/sofosbuvir (Harvoni), which had a 99% SVR rate with a 12-week regimen and did not need to be combined with interferon injections. Newer DAAs have been introduced since that time, including sofosbuvir/velpatasvir (Epclusa) and sofosbuvir/velpatasvir/voxilaprevir (Vosevi), also made by Gilead, elbasvir/grazoprevir (Zepatier) by Merck, and glecaprevir/pibrentasvir (Mavyret) from AbbVie.
The Cost of Hepatitis C Treatment
Though all of these drugs have been hailed as major medical breakthroughs, much of the discussion around them has focused on their exorbitant price tags. When sofosbuvir (Sovaldi) was released, it made news because a 12-week round of treatment came in at a total of $84,000. Harvoni cost even more -- $94,500 for a 12-week course, though some patients may be cured after only eight weeks, or $63,000. Gilead's newer offering, Epclusa, goes for just over $74,000. The gamechanger in the market may be Mavyret, which costs $26,500 for treatment. As of January 2019, there are also authorized generic versions of some of these drugs available at lower prices.
There have been many arguments about whether these prices may be justified if they actually do provide a permanent cure. Patients with hep C who are not cured often go on to need far more expensive care. One study estimated that yearly care for an HCV patient without liver damage is approximately $5,800. This goes up to over $27,000 each year for an HCV patient with decompensated cirrhosis of the liver, over $43,000 a year for an HCV patient with liver cancer, and over $93,000 a year for a patient who has had a liver transplant.
In the long term, it is likely cheaper for insurers to pay for treatment with a DAA than to wait and pay for ongoing care once the patient gets sicker. Moreover, curing those who have been diagnosed would also prevent the virus from spreading further, which could in turn keep future costs down.
Still, many insurers have limited who they will cover and under what circumstances. Restrictions include only paying for the drug in patients who are already experiencing some sort of liver damage and limiting or denying treatment for those who continue to use alcohol or drugs. A 2016 study found that 52% of HCV patients who were commercially insured (meaning they got insurance through their employers or purchased it on a state exchange) were at least initially denied coverage for their prescription. Insurers also denied coverage for 35% of patients covered under Medicaid and 15% covered under Medicare.
In 2015, the Obama administration's Centers for Medicare and Medicaid Services sent a notice to all state Medicaid administrators that limiting care in these ways runs counter to the legislation behind Medicaid, which says that state programs must cover all medically necessary treatment. The following year, a U.S. District Court judge ruled that Washington state had to lift its restrictions on treatment. Other states faced similar lawsuits.
While many programs, including state Medicaid programs, AIDS Drug Assistance Programs, and the Department of Veterans Affairs, have expanded coverage for HCV drugs in recent years, particularly as lower-cost medications hit the market, the high price tags are still a problem. Some state Medicaid administrators say they just can't afford to provide treatment to everyone who needs it.
A New Way to Pay
But Louisiana has been an innovator in ways to pay for hep C treatment. There are 39,000 people covered by Medicaid or in prison in Louisiana who are living with HCV. To treat all of those on Medicaid would cost $760 million, which is more than the state spends on K-12 education, Veterans Affairs, and its Department of Corrections combined, according to Rebekah Gee, M.D., Louisiana Secretary of Health. As part of an overall public health effort to eliminate HCV in her state, Gee worked to develop a new model of paying for the medication.
The state offered to enter into an exclusive agreement with the manufacturer of one of the available medications, in which it would pay a fixed price for an unlimited supply of the drug for particular populations. This allows the state to treat more people than it could if it paid on a case-by-case basis and likely gives the manufacturer more of the state's dollars, because all patients on Medicaid and in prison will be given the same medication and not the products of their competitors.
If the plan to eliminate HCV is successful, the costs and benefits to each should even out over time. The state may use more medication than it is paying for in the early years, as it tries to treat everyone who is living with the virus, but as treatment becomes widespread, fewer people contract it, meaning that in future years of the agreement, the state pays for more than it uses.
Louisiana's agreement was approved in June 2019 and went into effect this summer. It is likely that we'll see more states working on similar agreements or other ways to bring down the cost of treatment. Still, paying for a cure is only part of the battle.
There has been some progress in the fight against hepatitis C in recent years. In 2016, HCV-related deaths dropped by 7%, and the CDC has announced a plan to bring deaths down 65% by 2030, using a combination of screening, treatment, and prevention strategies.
One important component is increasing access to syringe services programs (SSP). Eighty percent of new HCV cases are attributed to drug use, and giving people access to safe injection equipment and treatment for drug addiction can lower transmission risks by over 70%. Unfortunately, SSPs remain controversial. According to the Community Access National Network, local counties and municipalities continue to shut down existing SSPs, "citing dubious reports of increased needle waste, failures to keep adequate exchange records, law enforcement opposition, enabling, and lack of oversight." As a result, there are only 270 SSPs in the United States, and only 20% of the people with HCV ages 15 to 29 live within 10 miles of one of these programs.
Widespread testing and treatment within the prison system is another necessary component in the fight against HCV. Remember, one in three people in prison have HCV, but only 22 states require people to be tested when they come into the system. In addition, few states provide sufficient access to treatment for the prison population. Between 2016 and 2019, at least 21 lawsuits had been filed as a means of forcing states to improve access. Treating people in prison not only reduces deaths within the system but also prevents infections in the community upon release.
The CDC also wants to address the recent rise of HCV in infants born to mothers living with the virus. In 2014, one of 308 U.S. births were to HCV-positive mothers. Additional screening for young women as well as prenatal screening could help bring these numbers down.
Combining these approaches with increased testing and screening, additional provider education, and options for accessing medications at lower costs will be the key to ending the hepatitis C epidemic.