Ledipasvir/sofosbuvir

🧮 Dose calculator

Chronic hepatitis C · Regimen source: FDA Harvoni · 2.3FDA Harvoni · 2.4, Table 2

• • Duration per Table 1 (8–24 weeks; with or without ribavirin). Children 17–<35 kg: 45/200 mg; <17 kg: 33.75/150 mg pellets. No renal adjustment. FDA Harvoni · 2.2FDA Harvoni · 2.4, Table 2FDA Harvoni · 2.6

Enter age and weight.

👥 Special populations

• 🤰 PregnancyUse with caution

  Label: no adequate human data; no adverse developmental outcomes in animals. With ribavirin the combination is contraindicated in pregnancy. FDA Harvoni · 8.1

  “No adequate human data are available to establish whether or not HARVONI poses a risk to pregnancy outcomes. In animal reproduction studies, no evidence of adverse developmental outcomes was observed with the components of HARVONI.”

• 🤱 BreastfeedingUse with caution

  Label: use with caution while breastfeeding; see the label text. FDA Harvoni · 8.2

  “When administered to lactating rats, ledipasvir was detected in the plasma of nursing pups likely due to the presence of ledipasvir in milk, without clear effects on nursing pups [see Data ].”

• 👶 ChildrenUse with caution

  The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Harvoni · 8.4

  “The safety, pharmacokinetics, and efficacy of HARVONI for treatment of HCV genotype 1 and 4 infection in treatment-naïve and treatment-experienced pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis have been established in an open-label, multicenter clinical trial (Study 1116, …”

• 👴 Older adultsNo specific problem stated

  Label: no specific difference or dose adjustment stated for older adults. FDA Harvoni · 8.5

  “No dosage adjustment of HARVONI is warranted in geriatric patients [see Clinical Pharmacology (12.3) ] .”

• ⚥ Females & males of reproductive potentialUse with caution

  Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Harvoni · 8.3

  “If HARVONI is administered with ribavirin, the information for ribavirin with regard to pregnancy testing, contraception, and infertility also applies to this combination regimen.”