Fosamprenavir in Infants and Children with HIV-1 Infection

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Fosamprenavir in Infants and Children with HIV-1 Infection

Dosing Recommendations


In therapy-naïve adults, fosamprenavir should be initiated at a dose of 1,400 mg twice daily. If boosted with 100 or 200 mg ritonavir, the dose can be given once daily. A regimen of fosamprenavir 700 mg twice daily plus ritonavir 100 mg twice daily is recommended for adults who have previously received other protease inhibitors and may also be used in therapy-naïve adult patients.

A twice-daily, weight-based dosing regimen is recommended for infants and children. Fosamprenavir should only be initiated in infants who were born at a minimum of 38 weeks gestation and are at least 4 weeks of age. In protease inhibitor-naïve patients, fosamprenavir may be initiated at dose of 30 mg/kg given twice daily. Ritonavir-boosted fosamprenavir may be used in protease inhibitor-naïve patients 4 weeks of age and older or protease inhibitor-experienced patients 6 months of age and older (Table 3). Once-daily dosing is not recommended for pediatric patients.

There is no information on dosing fosamprenavir in infants or children with hepatic impairment. In adults, a dose reduction to 700 mg twice daily, with or without ritonavir 100 mg once daily, is recommended for those with mild impairment (Child-Pugh scores of 5–6). In patients with moderate hepatic impairment (Child-Pugh scores of 7–9), fosamprenavir should be reduced to 700 mg twice daily without ritonavir for therapy-naïve patients or 450 mg twice daily with 100 mg ritonavir once daily for therapy-naïve or therapy-experienced patients. In those with severe hepatic impairment (Child-Pugh scores of 10–15), the dose of fosamprenavir should be reduced to 350 mg twice daily alone in therapy-naïve patients or 300 mg twice daily with 100 mg ritonavir once daily in therapy-naïve or therapy-experienced patients.

Fosamprenavir tablets may be taken with or without food. In adults, the oral suspension should be taken without food, but in children it may be given with food to improve palatability. While the oral suspension may be stored at room temperature, refrigeration may improve the taste. If emesis occurs within the first 30 minutes after a fosamprenavir dose, it should be repeated.

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