Vosevi

Vosevi is very well tolerated with minimal side effects. In fact, in clinical trials, very few people—0.2%—discontinued treatment due to side effects. The most commonly reported side effects are headache, fatigue, diarrhea and nausea. Asthenia (weakness), insomnia, rash and depression have also been reported, but in less than 10% of people. All adverse events are generally mild to moderate in severity and similar between people with and without compensated cirrhosis. There are no significant lab abnormalities of concern. Vosevi has not been studied in pregnant women or nursing mothers, so its impact on fetal development or nursing babies is unknown. Pregnant women or women who are trying to become pregnant should avoid use, if the addition of ribavirin is required (SEE ribavirin page).

Before starting Vosevi, 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. Vosevi should not be taken within 4 hours of antacids. If taking H2-receptor antagonists (used for heartburn), take Vosevi at the same time or separate by 12 hours at a dose that does not exceed doses comparable to famotidine 40 mg twice per day. Use of proton pump inhibitors (PPI) is not recommended, but if medically necessary, Vosevi can be taken with a PPI comparable to omeprazole 20 mg or lower. Vosevi should not be taken with the following HIV medications: efavirenz, atazanavir, lopinavir/ritonavir or tipranavir/ritonavir. Use caution and monitor renal function when taking Vosevi with tenofovir disoproxil fumarate (TDF). It should not be taken with the rifamycin antimicrobials, such as rifabutin, rifampin, or rifapentine, nor should it be taken with the anticonvulsants carbamazepine, phenytoin, phenobarbital or oxcarbazepine. It cannot be taken with St. John’s wort; in general, herbal products should be avoided due to lack of information about the potential for interaction. There are no interactions with methadone or other common medications used for opioid, alcohol or nicotine dependency. 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 should be changed during treatment with Vosevi. Sofosbuvir-based HCV regimens should be avoided if taking amiodarone due to possible symptomatic bradycardia (slow heart rate). Signs of bradycardia include fainting, dizziness, lightheadedness, weakness, excessive fatigue, shortness of breath, chest pains and confusion or memory problems. Consult a medical provider should any of these symptoms occur.

Of particular importance is Vosevi’s effectiveness in people with previous DAA treatment experience and HCV drug resistance. In POLARIS-1, 97% of people with GT1 achieved SVR12 (cure), and neither compensated cirrhosis nor presence of baseline resistance mutations appeared to affect outcomes. This is a wonderful achievement and offers hope to people who have previously failed to achieve cure after treatment.

NS3/4A protease inhibitors, such as voxilaprevir, are not recommended for people with moderate or severe liver impairment (Child-Pugh B/C), which is also called decompensated cirrhosis. Using Vosevi in decompensated cirrhosis may cause significantly higher amounts of voxilaprevir in the blood and may increase ALT (a liver enzyme).

In 2019, the FDA approved Vosevi’s use for people with kidney disease, including people on dialysis, with no need for dosage adjustment. Although it is not FDA approved for use in HIV coinfection, it may be considered if drug interactions are also assessed. Vosevi is currently only approved for use in adults.

For more information, GO TO hcvguidelines.org.

Black Box Warning

Before starting treatment with any direct-acting antiviral (DAA), including Vosevi, 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. Patients with current or past HBV infection should be monitored during HCV DAA treatment, and some may need to take HBV treatment. SEE HBV Reactivation for more information and consult your medical provider.