Finally, there’s good news for the many patients in opioid treatment programs (OTPs) who are infected with hepatitis C virus (HCV). New medications with success rates ranging from 90 percent to close to 100 percent are replacing older treatments—interferon injections and ribavirin—that required lengthy therapy, had an average cure rate of only 40 percent, and often were so poorly tolerated that patients discontinued therapy.
More good news: OTPs can now conveniently screen for HCV on-site, using a new 20-minute test for blood samples obtained by fingerstick or venipuncture.
Now, the caveat: The new HCV treatments can cost as much as $1,125 per dose—about $83,000 to $95,000 for a full course. Treatment usually takes 12 weeks, but can be as brief as 8 weeks or as long as 24.
Some providers aren’t paying; others are setting restrictions, some of which especially impact OTP patients—such as requiring them to be free of drug and alcohol abuse for a full year before starting treatment.
This article, the first in a series, discusses the reasons OTP patients are at risk of HCV infection; the tests OTPs can perform on-site, or refer elsewhere; and new medications that have the potential to dramatically change the outlook for patients afflicted with HCV.
The New Medications
The table below summarizes the new treatments. The reported price of the medications is the starting point for the discounts required by law for Medicaid, the Veterans Administration, the Department of Defense, and the prison systems. Medicare is prohibited by law from negotiating lower prices with pharmaceutical manufacturers.
New Medications for Treating Chronic HCV Infectiona
| Medication and Approval Date | Regimen | Cost |
| Sovaldi (sofosbuvir); December 2013, Gilead | Once daily, with ribavirin or with ribavirin and peginterferon (PEG) | About $84,000 for 12 weeksb |
| Harvoni (sofosbuvir/ ledipasvir); October 2014, Gilead | Once daily, as sole therapy | About $95,000 for 12 weeksb (some patients need only 8 weeks) |
| Olysio (simeprevir); November 2014, Janssen | Once daily─with sofosbuvir (as an interferon-and ribavirin-free treatment option)─or with ribavirin and PEG (side effects may lead to discontinuation) (approved for this use November 2013) | About $84,000 for 12 weeksb |
| Viekira Pak; December 2014 (ombitasvir, paritaprevir, ritonavir, co-packaged with dasabuvir tablets) (AbbVie) | As 4 pills (without ribavirin) or 6 pills (with ribavirin) | About $83,000 for 12 weeks |
a Sovaldi is for genotypes 1-4; the others are for genotype 1, the most common.
b Some patients need up to 24 weeks of treatment.
HCV genotype 1 afflicts about three-fourths of HCV-infected patients. The term genotype means main type, or strain; HCV subtypes also exist.
Discounts and Exclusions
With more people now eligible for Medicaid under the Affordable Care Act, some states have imposed restrictions that exclude all but the sickest patients from HCV treatment.
Under fire for the high cost of their drugs, pharmaceutical companies argue that they need to recoup the huge sums they invested to develop and market the new treatments. They also point out, correctly, that HCV treatments ultimately save the health care system money. Once patients are successfully treated, and no longer engage in behaviors that may lead to re-infection, they avoid ongoing medical expenses associated with hepatitis. Nor do they eventually require a liver transplant, at an estimated total cost of about $575,000. But Medicare would accrue future savings from costs of treatments currently paid by Medicaid and private payers.
As the brouhaha continues, patients infected with HCV need access to more-effective treatment. Health insurers, public payers, and pharmacy-benefit managers (PBMs) are looking for ways to help them get it. Some providers are working with drug companies to negotiate discounts. One example: A major prescription-drug benefit manager, Express Scripts Holding Co., has arranged a discount, in return for making AbbVie’s Viekira Pak the only option for its patients with genotype 1, the most common type of HCV—thus taking market share from Gilead’s drugs.
HCV Prevalence and Clinical Course
Chronic HCV infection is said to afflict about 3 million Americans, but including populations not counted in traditional surveys—people who are incarcerated, homeless, in medical facilities, or on active military duty—the likely total rises to about 5 million.
Fewer than half of those infected with HCV are aware of it; the acute infection may become chronic after six months, and it can take 20 years or more for symptoms to become obvious. Chronic HCV infection can lead to cirrhosis, liver failure, or liver cancer, leaving a liver transplant as the only life-saving measure.
OTP Patients and HCV Risk
Estimates indicate that 35 percent to 65 percent of OTP patients are chronically infected with HCV, largely because of their current or former intravenous drug use. Sharing and reusing needles and drug paraphernalia can transmit the virus, resulting in the higher infection rate in this population.
With HCV infection three to five times more common in the U.S. than HIV/AIDS—and more deadly—the Centers for Disease Control and Prevention (CDC) recommends routine HCV antibody testing (screening) for all current or former injection drug users. Yet few of them are currently being tested and treated. In addition, SAMHSA’s April 2013 Draft Federal Guidelines for Opioid Treatment recommend hepatitis C screening, directly or by referral, as part of the assessment and evaluation process.
HCV Screening and Viral Load Testing
OTPs and other facilities can perform the 20-minute rapid HCV antibody test on-site, or can send blood samples to laboratories. But screening tests do not distinguish between an existing HCV infection and a previous, inactive one; an HCV infection can clear without treatment, leaving antibodies in its wake.
To confirm an active HCV infection, a lab must also run what is known as a viral load test. The viral load is an estimate of the amount of active virus in the bloodstream at the time of the test. It’s an indication of the severity of the infection.
HCV Testing in OTPs and Non-OTPs
According to an N-SSATS Report dated October 23, 2014, in 2012, 61 percent of OTPs offered either on-site or off-site testing for HCV. (In comparison, only 13 percent of non-OTP outpatient substance abuse treatment facilities did so.)
On-site HCV testing in OTPs, less common than off-site testing, is decreasing. A recent national study published in the American Journal of Public Health found that only 34 percent of 383 OTPs surveyed offered on-site testing in 2011, compared to 53 percent in 2005.
Because off-site referrals “are associated with lower uptake of testing and treatment services, this trend constitutes a significant threat to HCV control in the United States,” the study’s authors said. OTPs affiliated with a hospital or receiving federal funds are the most likely to offer on-site testing, and the authors noted that the drop in on-site testing is likely associated with the concurrent sharp decline in the proportion of OTPs backed by federal funds.
Barriers to HCV Testing
The study identified potential barriers to the availability of on-site or off-site testing:
- Insufficient financial resources (funding and reimbursement)
- Insufficient human resources for ancillary services
- Ownership/affiliation characteristics (publicly owned OTPs may emphasize prevention; hospital-affiliated programs may have access to networks for testing)
OTPs that provided both methadone and buprenorphine were more likely to offer HCV testing, either on-site or off-site, than facilities offering buprenorphine treatment only. The latter were less likely to offer on-site HCV testing.
Linking Patients to HCV Services
Daniel Raymond, policy director of the Harm Reduction Coalition, is among national leaders developing and sharing models for linking OTP patients to HCV testing and treatment. He directed AT Forum to a pilot study published in the Journal of Addictive Diseases exploring ways OTPs can expand screening, prevention, and linkage to care for patients with—or at risk of—hepatitis infections.
Vaccines are available for hepatitis A and B, but not for hepatitis C. That’s why it’s essential for OTP patients who test HCV-free (by viral load test) to be linked with services to help prevent infection. Patients with a positive viral load test result need to be linked to care and treatment. (See the figure below.)
In a future article, AT Forum will investigate how successful OTPs in various urban and rural areas are in linking patients with testing and treatment services, and will determine who is paying—and how much—for those services.
Sources
Perlman DC, Jordan AE, McKnight C, et al. Viral hepatitis among drug users in methadone maintenance: Associated factors, vaccination outcomes, and interventions. J Addict Dis.2014; 33(4):322-331. doi: 10.1080/10550887.2014.969623.
Frimpong JA, D’Aunno T, Jiang L. Determinants of the availability of hepatitis C testing services in opioid treatment programs: Results from a national study [Epub ahead of print June 2014]. Am J Public Health. 2014; 104(6):e75-e82. doi: 10.2105/AJPH.2013.301827.
Services Offered by Outpatient-Only Opioid Treatment Programs: 2012. SAMHSA. The N-SSATS Report. October 23, 2014. http://www.samhsa.gov/data/sites/default/files/NSSATS%20_SR_162/NSSATS%20_SR_162/NSSATS-SR162-OpioidOOTx-2014.htm
Substance Abuse and Mental Health Services Administration (SAMHSA). Draft Federal Guidelines for Opioid Treatment. April 2013. http://www.dpt.samhsa.gov/pdf/FederalGuidelinesforOpioidTreatment5-6-2013revisiondraft_508.pdf