Therapeutic Indications

Abacavir is indicated for:

Human Immunodeficiency Virus (HIV) infection, in infants and children

Irrespective of gender only Infants (40 days - 1 year old) , Children (1 year - 12 years old)

Abacavir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection, in infants and children.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - Fixed dose

Human Immunodeficiency Virus (HIV) infection

Irrespective of gender only Adolescents (12 years - 18 years old) , Adults (18 - 65 years old)

Abacavir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.

The demonstration of the benefit of abacavir is mainly based on results of studies performed in treatment-naïve adult patients on combination therapy with a twice daily regimen.

Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 300 mg (15 ml) twice daily

Treatment 2: Oral - 600 mg (30 ml) once daily

Contraindications

Active ingredient Abacavir is contraindicated in the following cases:

End-stage renal disease

No gender/age discrimination

Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine. The pharmacokinetics of abacavir in patients with end-stage renal disease is similar to patients with normal renal function. Therefore no dosage reduction is required in patients with renal impairment. Based on limited experience Abacavir should be avoided in patients with end-stage renal disease.

Moderate or severe hepatic impairment

No gender/age discrimination

Abacavir is metabolised primarily by the liver. The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose; the median (range) AUC value was 24.1 (10.4 to 54.8) ug.h/ml. The results showed that there was a mean (90% CI) increase of 1.89 fold [1.32; 2.70] in the abacavir AUC, and 1.58 [1.22; 2.04] fold in the elimination half-life. No definitive recommendation on dosage reduction is possible in patients with mild hepatic impairment due to the substantial variability of abacavir exposure.

Abacavir is not recommended in patients with moderate or severe hepatic impairment.

Lactation

No gender/age discrimination

Abacavir and its metabolites are secreted into the milk of lactating rats. It is expected that these will also be secreted into human milk, although this has not been confirmed. There are no data available on the safety of abacavir when administered to babies less than three months old. It is therefore recommended that mothers do not breast-feed their babies while receiving treatment with abacavir.

Pregnancy

No gender/age discrimination

Abacavir is not recommended during pregnancy. The safe use of abacavir in human pregnancy has not been established. Placental transfer of abacavir and/or its related metabolites has been shown to occur in animals. Toxicity to the developing embryo and foetus occurred in rats, but not in rabbits. The teratogenic potential of abacavir could not be established from studies in animals.

Positive for the HLA-B*5701 allele

No gender/age discrimination

Abacavir should never be initiated in patients with a positive HLA-B*5701 status, nor in patients with a negative HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavir-containing regimen.