Can a patient with a low viral load and no significant fibrosis take Mavyret (glecaprevir/pibrentasvir) for hepatitis treatment?

From the Guidelines

Yes, a patient with a low viral load and no significant fibrosis can take Mavyret (glecaprevir/pibrentasvir) for hepatitis C treatment. The patient's viral load of 10,000 and fibrosis score of 0.17, indicating no fibrosis (F0), make them an ideal candidate for Mavyret treatment 1. The standard regimen is three tablets taken once daily with food for 8 weeks in treatment-naïve patients without cirrhosis. This shorter duration is a key advantage of Mavyret compared to older treatments that required 12-24 weeks.

Key Considerations

• The medication works by directly targeting the hepatitis C virus, with glecaprevir inhibiting the NS3/4A protease and pibrentasvir blocking the NS5A protein, both essential for viral replication.
• Patients with low viral loads often respond excellently to treatment, with cure rates exceeding 95% 1.
• Minimal fibrosis is actually advantageous, as the medication can work more effectively before significant liver scarring develops.
• Patients should be monitored for potential side effects, which may include headache, fatigue, and nausea, though these are typically mild.
• Mavyret should not be used in patients with moderate to severe liver impairment (Child-Pugh B or C) or those with certain medication interactions.

Treatment Recommendations

• The European Association for the Study of the Liver (EASL) recommends simplified treatment without knowledge of the HCV genotype and subtype to facilitate the cascade of care 1.
• The only information needed to start treatment with Mavyret is the presence of HCV replication and possible drug-drug interactions.
• A simple non-invasive marker score, such as FIB-4 or APRI, can be used to check for advanced fibrosis (F3) or cirrhosis (F4) prior to therapy.

From the FDA Drug Label

MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with chronic HCV genotype (GT) 1,2,3,4,5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)

Treatment-Naïve Patients HCV Genotype Treatment Duration No Cirrhosis Compensated Cirrhosis (Child-Pugh A) 1,2,3,4,5, or 6 8 weeks 8 weeks

The patient has a low viral load of 10,000 and no significant fibrosis with a Fibrosis Score of 0.17 and Fibrosis Stage of F0 - No fibrosis. Based on the drug label, Mavyret is indicated for patients without cirrhosis, which applies to this patient. Therefore, this patient can take Mavyret for hepatitis treatment, following the recommended 8-week treatment duration for treatment-naïve patients without cirrhosis 2.

From the Research

Patient Eligibility for Mavyret Treatment

The patient in question has a viral load of 10,000 and labs indicating no significant fibrosis (Fibrosis Score: 0.17, Fibrosis Stage: F0 - No fibrosis).

• The patient's low viral load and lack of significant fibrosis are positive indicators for treatment with Mavyret (glecaprevir/pibrentasvir) 3.
• A study published in the European journal of hospital pharmacy: science and practice found that patients with low-grade hepatic fibrosis (F0-2) had a 100% sustained virological response (SVR) rate when treated with glecaprevir/pibrentasvir (GLE/PIB) 3.
• Another study published in Zeitschrift fur Gastroenterologie found that the combination of SOF+G/P ± RBV was effective as a salvage regimen after re-treatment failure with SOF/VEL/VOX, although this study did not specifically address patients with low viral loads and no significant fibrosis 4.
• The American journal of gastroenterology published a study that found sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) to be an effective regimen for virologic failures to G/P, but again, this study did not specifically address the patient's condition 5.
• A single-arm trial published in The lancet. Gastroenterology & hepatology found that sofosbuvir-velpatasvir-voxilaprevir was safe and efficacious for the re-treatment of individuals infected with HCV genotype 4 non-a/d subtypes with frequent baseline NS5A resistance-associated substitutions, following failure of previous direct-acting antiviral treatment 6.

Treatment Considerations

• The patient's low viral load and lack of significant fibrosis suggest that they may be a good candidate for treatment with Mavyret (glecaprevir/pibrentasvir) 3.
• However, the patient's specific genotype and any potential resistance-associated substitutions should be considered when determining the best course of treatment 4, 5, 6.
• The patient's overall health and medical history should also be taken into account when determining the best treatment option.

Key Findings

• Mavyret (glecaprevir/pibrentasvir) has been shown to be effective in treating patients with low-grade hepatic fibrosis (F0-2) 3.
• The combination of SOF+G/P ± RBV may be an effective salvage regimen after re-treatment failure with SOF/VEL/VOX 4.
• Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) has been shown to be an effective regimen for virologic failures to G/P 5.
• Sofosbuvir-velpatasvir-voxilaprevir has been found to be safe and efficacious for the re-treatment of individuals infected with HCV genotype 4 non-a/d subtypes with frequent baseline NS5A resistance-associated substitutions, following failure of previous direct-acting antiviral treatment 6.