Hepatitis C-infected Organ Transplantation into Non-Hepatitis C-infected Recipients

February 20, 2018 | Special HTA Reports


HCV invades the liver and leads to inflammation. About 75% to 85% of individuals infected with HCV develop chronic infection; of those, 60% to 70% develop chronic liver disease. Millions of people worldwide have chronic HCV infection, and approximately 399,000 die from liver cirrhosis or hepatocellular carcinoma each year (see the Medscape article Hepatitis C). The estimated incidence of HCV infection in the United States in 2014 was 30,500 acute cases, and an estimated 2.7 to 3.9 million people in the United States have chronic HCV, according to the U.S. Centers for Disease Control and Prevention. (See Hepatitis C FAQs for Health Professionals. ) People at the highest risk of contracting HCV are current or former injection drug users. Blood tests for diagnosing HCV infection include antibody testing using enzyme immunoassays, rapid diagnostic tests, and point-of-care tests, qualitative and quantitative assays for HCV RNA based on polymerase chain reaction (PCR), and HCV genotyping. A liver biopsy is not mandatory unless the diagnosis is uncertain or other diseases are suspected.

HCV has several genotypes, and the genotype of the virus infecting the individual is a variable that must be considered when determining appropriate treatment. HCV genotypes are genetically distinct groups of the virus that have arisen during the virus' evolution. About 75% of HCV-infected Americans have genotype 1 (subtypes 1a or 1b), and 20% to 25% have genotype 2 or 3. Fewer patients are infected with HCV genotypes 4, 5, or 6. Most patients with HCV have only one main genotype, not multiple genotypes. Genotype 4 is much more common in Africa than in many other parts of the world; genotype 6 is common in Southeast Asia, and each area of the world has its own distribution of genotypes. (See Hepatitis C Genotypes and Quasispecies for more information. )

HCV infection is now curable; about 95% of patients are cured using oral DAA drugs. DAAs target different HCV genotypes. The first DAA became commercially available in 2011, and several more followed over the next few years. These drugs interfere with HCV replication and have sustained virologic response of 90% to 95%. In August 2017, FDA approved the first DAA (Mavyret™, AbbVie, Inc., North Chicago, IL, USA) that targeted all 6 HCV genotypes and achieved a sustained virologic response in 8 weeks rather than the 12 weeks of treatment that other DAAs have required. When to treat and which DAA to give are based on guidelines from the Infectious Diseases Society of America (IDSA) and the American Association for the Study of Liver Diseases (AASLD) in collaboration with the International Antiviral Society-USA. (See HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. ) The IDSA and AASLD recommend treatment for all patients with chronic HCV infection except for patients with a short life expectancy. Patients with advanced liver disease, liver transplant recipients, and patients with extrahepatic manifestations of chronic HCV infection should be given special consideration for treatment. The guideline also states that “despite a growing body of evidence that HCV treatment is cost-effective and may even be cost saving over the long term in some cases, many U.S. payers—especially those offering Medicaid insurance products—continue to limit access to HCV treatment. " Access to DAAs has been limited due to their high cost (see the article, Hepatitis C Virus: A Review of Treatment Guidelines, Cost-effectiveness, and Access to Therapy). Sofosbuvir (Sovaldi®), approved in the United States in 2013, had a wholesale acquisition cost (WAC) of $84,000 for a 12-week course of treatment ( about $1,000 per pill) (see Price and Affordability of Direct-acting Antiviral Regimens for Hepatitis C Virus in the United States). The WAC is the publically available list price a pharmaceutical company sets. As additional competing DAAs entered the market, greater discounts and rebates have become available. The average negotiated discount is now about 46% of the WAC. According to GoodRx, Mavyret pricing was set at $13,200 per month before discounts, or $26,400 per treatment course, which is substantially lower than pricing of other DAAs.

For additional information on how these drugs are used for specific HCV genotypes, see the Medscape article, Hepatitis C Treatment & Management.

Each day, about 20 people on an organ transplant waitlist in the United States die waiting for an organ transplant (see United Network for Organ Sharing). More than 115,000 individuals need an organ transplant. The organ supply is limited, and 2017 was the first year that more than 10,000 people donated organs upon their death. Table 1 presents national data from the Organ Procurement and Transplantation Network on the number of cadaveric donors from 2013 to 2017. The table also presents data on the organs transplanted and the HCV status. In 2017, only 1,427 organs from HCV- positive individuals were used for transplantation. Of HCV-infected organ transplants in 2017, kidneys were the most transplanted organ (640), followed by livers (572), lungs (112), and hearts (101).

Kidney transplantation is indicated for individuals with end-stage renal disease (see the Medscape article, Renal Transplantation). Diabetes, hypertension, and glomerulonephritis are the primary underlying conditions leading to end-stage renal disease. For kidney transplant patients, quality of life is improved and risk of death is reduced compared with those on maintenance dialysis. Patients require immunosuppressive medications that increase the...

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