Hep C: An Anti-Viral Success Story
Hepatitis C is the primary cause of liver cancer and the need for liver transplants among patients infected with the virus.
Infection is often the result of coming into contact with contaminated blood, usually through injected drug use, but also from sexual intercourse, babies born to infected mothers, sharing of contaminated instruments (toothbrushes, razors, nail clippers, glucose monitors, etc.), and unregulated tattoos and body piercings.(8) There is no vaccine for hepatitis C, as there is for A and B.
Cases of hepatitis C begin as an acute infection within the first six months of exposure, and for many people, this stage has no symptoms. As the disease progresses, possible symptoms that could occur within weeks or months after exposure include fever, fatigue, nausea, vomiting, dark urine, clay colored bowel movements, joint pain, and yellow skin or eyes. Most cases (approximately 75%) develop into a chronic infection, which in turn, result in large amounts of cirrhosis if left untreated. Without treatment, liver failure and death may occur.(4,5) The CDC estimates that over 2.4 million persons are living with hepatitis C in the US.
Interferon injection treatments, in use from the 1980s until 2015, have not been effective in reducing the viral burden from the body. Patients with this therapy were often subject to long-term treatments with significant side effects.(7) Although there have been incremental improvements over the years, treatments have largely become more effective for patients since 2015. Since then, therapies have changed to the use of protease inhibitors that interfere with viral replication with the liver cells.(7) Protease inhibitor treatments are available in oral pill formats that can be taken over eight to twelve weeks.(2,4,7)
Different treatments target specific hepatitis C genotypes, and may not be utilized if the patient has cirrhosis or other medical conditions. Consequently, it is important to know which genotype of hepatitis C a patient has and the health and condition of their liver.(5) Genotype 1 is the most common type of hepatitis C and, thankfully, most of the new treatments cover this type.(2)
Zepatier, Mavyret, Harvoni, Viekira Pak, and Epclusa are some of the brand names of treatments available in pill format.(2,3,4) Each treatment regimen varies from taking one to three pills per day. The drug Mavyret, FDA approved in 2017, targets all genotypes of hepatitis C. This is a welcome option for patients who may have a less common genotype. However, for Mavyret to be effective there needs to be mild to no evidence of cirrhosis present.(4) Another benefit to the Mavyret treatment is the eight-week treatment duration.
In 2016, Epclusa was the first FDA-approved treatment for all types of hepatitis C in pill format, with a low number of side effects and a high cure rate. In 2020, FDA approved Epclusa to treat hepatitis C in children ages six years and older; another breakthrough in earlier treatment options for younger patients diagnosed with hepatitis C.(4,7) This medicine offers a twelve week regimen with a low number of side effects and a high cure rate.
The availability and effectiveness of today’s treatments offers significant hope to those diagnosed with hepatitis C. However, “the cure” does not mean living completely virus free. Efficacy is defined as blood concentrations below detectable levels three months post-treatment.(3) A 2015 study showed patients who achieve this milestone have a lower risk of liver-related deaths.(4) While patients may never be 100% free of hepatitis C, the reduced viral burden allows patients to live longer and healthier lives.
Meet the author
SENIOR TECHNICAL SERVICES AND R&D MANAGER at HARDY DIAGNOSTICS
Anna Klavins, RAC-Devices, B.S Cellular and Molecular Biology
Anna Klavins is the Senior Technical Services and R&D Manager at Hardy Diagnostics where she oversees the Research and Development, Design and Development, Quality Control, Technical Support, and Performance Studies teams. She earned a Molecular and Cellular Biology B.S. degree from Cal Poly San Luis Obispo while playing for the Division I NCAA women’s tennis team. Since joining Hardy Diagnostics in mid-2016, she has authored sixteen FDA 510(k) submissions for class II microbiology in vitro diagnostic devices. She has published in the Journal of Clinical Microbiology and the Journal of AOAC INTERNATIONAL, as well as presents in vitro diagnostic device performance evaluation results annually at global scientific conferences such as ASM Microbe, the AOAC Annual Meeting, and the International Association of Food Protection annual meeting. She is an advisor to the Joint CLSI-EUCAST Working Group and has earned the RAC-Devices certification.