Dosage and Administration of Harvoni for Different Patient Populations

Recommended Dosage in Adults

The recommended dosage of HARVONI in adults with HCV genotypes 1٫ 4٫ 5٫ or 6 is one tablet (90 mg ledipasvir and 400 mg sofosbuvir) taken orally once daily٫ with or without food.​ The daily dosage of ribavirin is weight-based.​

Dosage Adjustment Based on Weight

The daily dosage of ribavirin is weight-based when used in combination with HARVONI.​ For patients weighing less than 75 kg, the recommended dosage is 1000 mg, while for those weighing 75 kg or more, the dosage is 1200 mg.​ Ribavirin should be administered orally in two divided doses with food to optimize its effectiveness.​

Recommended Dosage in Pediatric Patients

For pediatric patients aged 3 years and older with HCV genotypes 1, 4, 5, or 6, the recommended dosage of HARVONI is based on weight.​ Pediatric patients should follow a weight-specific dosing regimen using HARVONI tablets or oral pellets as directed by the healthcare provider.​ It is essential to administer the medication according to the weight-based guidelines to ensure proper treatment efficacy.​

Special Populations⁚ Patients with Cirrhosis

For patients with cirrhosis, a fixed daily dose of ledipasvir/sofosbuvir (HARVONI) is recommended, while ribavirin dosage is weight-based, with adjustments made for a patient’s body weight.​ The treatment approach should consider the severity of cirrhosis and individual patient factors to ensure optimal outcomes and address potential complications associated with advanced liver disease.​

Dosage Adjustments in Patients with Renal Impairment

No dosage adjustment of HARVONI is recommended in patients with renal impairment, including those with end-stage renal disease (ESRD) on dialysis.​ Patients with renal impairment can take HARVONI with or without ribavirin as per the recommendations provided. Regular monitoring and appropriate management are essential for patients with renal issues undergoing treatment with HARVONI.​

Dosage and Administration in HIV Co-Infected Patients

For adult and pediatric patients aged 3 years and above with HCV genotype 1, 4, 5, or 6, including HIV co-infected patients, who do not have cirrhosis, the recommended treatment with HARVONI is typically for 12 weeks.​ However, in certain cases, a treatment duration of 8 weeks may be considered for previously untreated genotype 1-infected patients.​ The decision on the treatment regimen and duration should be made based on individual patient characteristics and in consultation with healthcare providers.​

Duration of Treatment Based on Patient Population

Patients with chronic hepatitis C virus (HCV) genotypes 1, 4, 5, or 6 are typically treated with HARVONI for a specific duration depending on their specific patient population subgroup.​ Adult and pediatric patients aged 3 years and above without cirrhosis are recommended to undergo a 12-week treatment regimen with HARVONI.​ In certain cases, such as previously untreated genotype 1-infected adult patients without cirrhosis, an 8-week treatment duration may be considered based on the individual’s condition and medical history.​

Considerations for Missed Doses

If a dose of HARVONI is missed and remembered within 18 hours of the regularly scheduled time٫ the missed dose should be taken as soon as possible with or without food.​ However٫ if more than 18 hours have passed since the missed dose٫ the patient should skip the missed dose and continue the regular dosing schedule.​ Double dosing or taking extra tablets to make up for missed doses is not advised.​ It is crucial to follow the dosing schedule closely to maximize the effectiveness of the treatment.​

Potential Drug Interactions and Contraindications

When considering the administration of HARVONI, it is essential to be cautious of potential drug interactions and contraindications.​ Special attention should be paid to the use of P-glycoprotein (MDR1) efflux transporter inhibitors alongside HARVONI٫ as they can alter the level or effect of certain medications.​ It is advisable to consult the full prescribing information before initiating treatment to ensure compatibility with other medicines. Additionally٫ contraindications should be identified and addressed to prevent any adverse effects that may arise from incompatible drug combinations.​