Standard DoseThree tablets once daily with food. Each tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir for a total daily dose of 300 mg/120 mg. It is important to take all three tablets at the same time—do not separate throughout the day. See treatment duration tables at positivelyaware.com/mavyret. The number of weeks on treatment depends on such things as cirrhosis status and previous therapy. New oral pellet formula approved in June now allows dosing in children age 3 and older (as opposed to age 12 and older previously), without cirrhosis or with compensated cirrhosis, based on weight. (See Briefly, page 6).
Take your missed dose as soon as possible unless it is less than 12 hours until your next dose. Do not double up on your next dose.
Black Box Warning
Before starting treatment with any direct-acting antiviral (DAA), including Mavyret, patients should take a blood test to check for hepatitis B (HBV) infection. HBV infection could worsen or reactivate during or after DAA treatment, potentially leading to serious liver problems, including liver failure or death. People with current or past HBV infection should be monitored during HCV DAA treatment, and some may need to take HBV treatment. See HBV Reactivation on page 37 for more information and consult your medical provider.
Treatment-naïve patients: If you’ve never taken HCV treatment before, you’ll take it as follows
|Genotype||No cirrhosis||Compensated Cirrhosis (Child-Pugh A)|
|1, 2, 3, 4, 5, 6||8 weeks||8 weeks|
Treatment-experienced patients: If you have taken HCV treatment before, you’ll take it as follows:
|Genotype||Previous treatment regimen||No cirrhosis||Compensated Cirrhosis
|1||NS5A inhibitor* without prior treatment with an NS3/4A protease inhibitor**||16 weeks||16 weeks|
|1||NS3/4A protease inhibitor** without prior treatment with an NS5A inhibitor*||12 weeks||12 weeks|
|1,2,4,5,6||Prior treatment with (peg)interferon, ribavirin and/or sofosbuvir but no other HCV treatment||8 weeks||12 weeks|
|3||Prior treatment with (peg)interferon, ribavirin and/or sofosbuvir but no other
|16 weeks||16 weeks|
* In clinical studies, this included ledipasvir/sofosbuvir or daclatasvir + (peg)interferon + ribavirin. Other NS5A inhibitors include elbasvir, velpatasvir, and ombitasvir.
** In clinical studies, this included simeprevir + sofosbuvir, simeprevir, boceprevir, or telaprevir + (peg)interferon + ribavirin.
AWP$15,840 / month
Potential Side Effects and Toxicity
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 headaches and fatigue were reported by clinical trial participants at rates higher than 10% (16% and 11%, 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. Mavyret has not been studied in pregnant women or nursing mothers, so its impact on fetal development or nursing babies is unknown.
Potential Drug Interactions
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 illicit. 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 ritonavir as a booster, 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 is not recommended due to 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 pan-genotypic (active against all 6 genotypes) regimen that cures most people without ribavirin in as few as 8 weeks of treatment. Some people may need to take Mavyret for up to 16 weeks, depending on previous treatment experience and presence of cirrhosis. The overall cure rate (sustained virologic response, or SVR) across all genotypes was 97.5%. It is an excellent regimen for people with kidney disease, including patients on hemodialysis, curing 98% of patients with severe kidney disease in 12 weeks of treatment (EXPEDITION-4) as well as for patients who are post-liver or kidney transplant.
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.