From the Guidelines
Treatment for chronic hepatitis C without hepatic coma should involve an 8-12 week course of direct-acting antiviral (DAA) therapy, such as ledipasvir/sofosbuvir, elbasvir/grazoprevir, or ombitasvir/paritaprevir/ritonavir plus dasabuvir and ribavirin, depending on the hepatitis C virus genotype and presence of cirrhosis, as recommended by the 2017 clinical practice guidelines 1.
Key Considerations
- The specific regimen depends on the hepatitis C virus genotype, prior treatment history, and the presence of cirrhosis.
- For most non-cirrhotic patients, ledipasvir/sofosbuvir for 8 weeks is highly effective, but treatment could be shortened to 8 weeks in patients without liver cirrhosis and without HIV co-infection whose baseline HCV RNA level is less than 6,000 IU/mL 1.
- Patients with compensated cirrhosis may require 12 weeks of therapy, and daclatasvir and sofosbuvir could be administered for 12 weeks to patients with compensated cirrhosis, or they could receive daclatasvir and sofosbuvir for 24 weeks 1.
Treatment Options
- Ledipasvir/sofosbuvir should be administered for 12 weeks, but could be shortened to 8 weeks in certain patients 1.
- Elbasvir/grazoprevir should be administered for 12 weeks to patients without NS5A RASs, and elbasvir/grazoprevir and ribavirin could be administered for 16 weeks to patients with NS5A RASs 1.
- Ombitasvir/paritaprevir/ritonavir plus dasabuvir and ribavirin should be administered for 12 weeks to patients without liver cirrhosis, and for 24 weeks to patients with compensated cirrhosis 1.
Monitoring and Precautions
- Before starting treatment, baseline laboratory tests including HCV viral load, genotype, complete blood count, liver function tests, and assessment of renal function are necessary.
- During treatment, patients should avoid alcohol and certain medications that may interact with DAAs.
- Regular monitoring of liver function is recommended.
From the FDA Drug Label
MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) The recommended oral dosage of MAVYRET in adults is 3 tablets taken at the same time once daily with food (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg)
The treatment for chronic hep C without hepatic coma is MAVYRET. The recommended duration of treatment is:
- 8 weeks for treatment-naïve patients with no cirrhosis or compensated cirrhosis (Child-Pugh A) with HCV genotype 1,2,3,4,5, or 6
- 12-16 weeks for treatment-experienced patients, depending on the patient's prior treatment experience and HCV genotype 2
From the Research
Treatment Options for Chronic Hep C without Hepatic Coma
- The treatment for chronic hepatitis C without hepatic coma typically involves the use of direct-acting antivirals (DAAs) 3, 4.
- Sofosbuvir-velpatasvir is a single-tablet regimen that has been shown to be effective in treating HCV infection of all genotypes, with reported rates of sustained virological response at 12 weeks after treatment completion ranging from 95% to 100% 3.
- Glecaprevir/pibrentasvir is another pangenotypic drug that can be used to treat naive non-cirrhotic or compensated cirrhosis (Child-Pugh-Score A) for eight weeks 5.
- The combination of Sofosbuvir plus Velpatasvir and Glecaprevir plus Pibrentasvir has been identified as the most effective and relatively safe in managing chronic hepatitis C virus genotype 2 (HCV GT2) infection, with a sustained virological response rate of 100% (95% CI 99-100%) 6.
Treatment Duration and Regimen
- The duration of treatment with sofosbuvir-velpatasvir is 12 weeks regardless of the HCV genotype involved, previous treatment, and the presence of cirrhosis or baseline resistance-associated NS5A mutations 3.
- In patients with decompensated cirrhosis, sofosbuvir-velpatasvir must be used in combination with ribavirin 3.
- The combination of SOF+glecaprevir/pibrentasvir + Ribavirin can be used as a salvage regimen after re-treatment failure with SOF/VEL/VOX 7.
Safety and Efficacy
- DAAs have been shown to be safe and well-tolerated, with sustained virological response rates above 95% 4.
- The most common adverse events reported with DAAs are fatigue, headache, nausea, and nasopharyngitis 3, 6.
- Viral eradication is associated with a better quality of life and with lower morbidity and mortality 4.