Mavyret
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Take missed dose as soon as possible unless it is less than 12 hours before your next dose. Do not double up on your next dose.
Mavyret pack (50/20 mg pellets) (pediatric): $10,184–$20,367 / month, based on dose required
Before starting Mavyret, be sure to tell your medical provider or pharmacist about all the medications, supplements and herbal products you take, whether they are prescribed, over-the-counter or recreational. It is important to report any changes to your medications as they happen during treatment. Mavyret should not be taken with HIV medications that require a booster (ritonavir or cobicistat), such as atazanavir and darunavir, to increase drug levels. Mavyret should not be taken with the HIV medications efavirenz or etravirine. It should also not be taken with rifampin or carbamazepine due to decreased concentrations of both components of Mavyret. Use with certain statins (cholesterol medicine) may cause increased risk of muscle pain (myopathy) or muscle breakdown (rhabdomyolysis). Your doctor should determine if your statin may be continued or changed during treatment with Mavyret. There are no interactions with methadone or other common medications used for opioid, alcohol or nicotine dependency. Use of ethinyl estradiol (estrogen)-containing birth control (specifically doses greater than 20 mcg per day) is not recommended due to a potential increase in ALT (a liver enzyme). Mavyret should not be used with cyclosporine doses higher than 100 mg daily. It cannot be taken with St. John’s wort; in general, herbal products should be avoided due to lack of information regarding potential for interaction.
Mavyret is a very well-tolerated medication with minimal side effects. In clinical trials, very few people (about 0.1%) discontinued Mavyret due to side effects. Only fatigue and headaches were reported by clinical trial participants at rates higher than 10% (11% and 16%, respectively), with even fewer reporting nausea or diarrhea. Rates of side effects are not affected by treatment duration, presence of cirrhosis, HIV/HCV co-infection, history of kidney transplant or adolescence. There are no serious lab abnormalities expected. Rapid reduction in hepatitis C viral load during direct-acting antiviral therapy (DAA) may lead to improvement in glucose metabolism in people with diabetes, potentially resulting in symptomatic hypoglycemia if anti-diabetic agents are continued at the same dose. People with diabetes should be monitored for changes in glucose tolerance, particularly within the first three months. Modification of antidiabetic therapy may be necessary. Hepatic decompensation and hepatic failure (including fatal cases) have been reported, typically occurring within the first four weeks of starting treatment. Most patients with severe outcomes had either advanced liver disease with moderate or severe hepatic impairment prior to treatment initiation or compensated cirrhosis with mild liver impairment at baseline but with a prior decompensation event (e.g., history of ascites, variceal bleeding or encephalopathy). Additionally, rare cases have been reported in people without cirrhosis or with compensated cirrhosis (often with evidence of portal hypertension), with concomitant use of medications that are not recommended, or in individuals with other confounding factors (such as serious liver-related medical or surgical comorbidities). In individuals with compensated cirrhosis (Child-Pugh class A), transient elevations in bilirubin (<2 ULN) without concurrent elevations in liver enzymes (ALT/AST), may occur early in treatment (generally within the first two weeks); this usually resolves with continued treatment. Liver function test results should be monitored as clinically indicated in individuals with compensated cirrhosis (Child Pugh class A) or with evidence of advanced liver disease (e.g., portal hypertension). Treatment should be discontinued in people who develop signs or symptoms of hepatic decompensation/failure. Mavyret has not been studied in people who are pregnant or nursing, so its impact on fetal development or nursing babies is unknown.
See “Black Box Warning” on hepatitis B testing and treatment.
Mavyret is a pangenotypic (active against all 6 genotypes) regimen that cures most people in as few as 8 weeks of treatment. Some people may need to take Mavyret for 12 or 16 weeks, depending on HIV status, previous treatment experience and presence of cirrhosis. The overall cure rate (sustained virologic response, or SVR) across all genotypes was 97.5%.
Mavyret can be used in several special populations. It is an excellent regimen for people with kidney disease, including people on hemodialysis, curing 98% who had severe kidney disease in 12 weeks of treatment (EXPEDITION-4) as well as for people who are post-liver or kidney transplant. It is also approved for children age 3 and older.
NS3/4A protease inhibitors, such as glecaprevir, are not recommended for people with moderate or severe liver impairment (Child-Pugh B/C), which is also called decompensated cirrhosis.
For more information, GO TO hcvguidelines.org.