Abacavir
abacavir is indicated in antiretroviral combination therapy for HIV infection in adults, adolescents and children.
Source:
EMA
Active Ingredients:
Indications
Representation
No sex-specific representation data
Efficacy
No sex differences in efficacy data
Posology
No sex-specific posology data
Potential Side Effects
No sex-specific potential side effect data
Sex- and gender-specific information
Men
Women
Disease prevalence by sex
43.8-47.6%
52.4-56.2%
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex differences in data
In subgroup analyses of once-daily versus twice-daily abacavir plus lamivudine in the paediatric ARROW study, no significant effect of sex on efficacy was reported.
Sex-specific posology
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
N / A
Placental transfer of abacavir occurs, and more than 800 first-trimester and more than 1000 second/third-trimester exposures indicated no malformative or foetal/neonatal effect. Abacavir is excreted into human milk, and women living with HIV are recommended not to breast-feed to avoid HIV transmission; there are no safety data for babies less than three months old.
Sex-specific non-clinical findings
Animal fertility studies showed no effect on male fertility.
Animal fertility studies showed no effect on female fertility.
Disease prevalence by sex
Men
43.8-47.6%
Women
52.4-56.2%
Clinical study participation by sex
Sex distribution not reported in the evaluated sources.
Representation Gap
No sex-specific data
N / A
Sex-specific efficacy/accuracy
No sex differences in data
In subgroup analyses of once-daily versus twice-daily abacavir plus lamivudine in the paediatric ARROW study, no significant effect of sex on efficacy was reported.
Sex-specific posology
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific differences in possible side effects
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Pregnancy / lactation
Men
N / A
Women
Placental transfer of abacavir occurs, and more than 800 first-trimester and more than 1000 second/third-trimester exposures indicated no malformative or foetal/neonatal effect. Abacavir is excreted into human milk, and women living with HIV are recommended not to breast-feed to avoid HIV transmission; there are no safety data for babies less than three months old.
Sex-specific non-clinical findings
Men
Animal fertility studies showed no effect on male fertility.
Women
Animal fertility studies showed no effect on female fertility.
General information
General Efficacy
Primary endpoints: The main efficacy endpoint across pivotal studies was virologic response, assessed as the proportion of patients with suppressed or undetectable plasma HIV-1 RNA at Week 48. Depending on the study this was reported as undetectable viral load <400 copies/ml, plasma HIV-1 RNA 50 copies/ml, or in ARROW the primary endpoint of HIV-1 RNA <80 c/ml at Week 48. Secondary endpoints: Supportive endpoints included corresponding rise in CD4 cells, Week 96 HIV-1 RNA <80 c/ml as a secondary endpoint in ARROW, other virologic thresholds (<200, <400 and <1000 c/ml), and reductions in HIV-1 RNA measured by AAUCMB in CAL30001.
General Posology
Oral tablets or oral solution. Adults, adolescents and children weighing at least 25 kg: 600 mg daily as 300 mg twice daily or 600 mg once daily. Tablet weight-band dosing: 20 kg to <25 kg, 450 mg daily (150 mg in the morning plus 300 mg in the evening, or 450 mg once daily); 14 to <20 kg, 300 mg daily (150 mg twice daily or 300 mg once daily). Oral solution: from 1 year of age, 8 mg/kg twice daily or 16 mg/kg once daily up to 600 mg/day; from 3 months to 1 year, 8 mg/kg twice daily, with 16 mg/kg/day once daily only if twice-daily dosing is not feasible. Children less than 3 months: limited experience, no specific dosage recommendation. When switching from twice daily to once daily, take the once-daily dose about 12 hours after the last twice-daily dose, then continue every 24 hours.
Further Dose Adjustments
Do not initiate abacavir in patients with hypersensitivity to abacavir or its excipients, positive HLA-B*5701 status, or suspected prior abacavir hypersensitivity despite negative HLA-B*5701 status.
Possible Side Effects
Common adverse reactions were anorexia, headache, nausea, vomiting, diarrhoea, rash (without systemic symptoms), fever, lethargy and fatigue. Serious adverse reactions included abacavir hypersensitivity reactions; rare pancreatitis; very rare erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and lactic acidosis. Abacavir-containing products should be permanently discontinued if hypersensitivity cannot be ruled out.
Contraindications
Hypersensitivity to abacavir or any excipients; abacavir should never be initiated in patients with a positive HLA-B*5701 status or in patients with a negative HLA-B*5701 status who had a suspected prior abacavir hypersensitivity reaction.
Clinical Trial Type and Population
Clinical efficacy and safety were evaluated in adult treatment-naïve and treatment-experienced HIV-infected patients, and paediatric HIV-infected patients. Major studies described were CNA30024 (n=654, antiretroviral therapy-naïve), ACTG5095 (n=1147, antiretroviral naïve adults), CNA30021 (n=770, therapy-naïve adults, primarily asymptomatic CDC stage A), CAL30001 (n=182, treatment-experienced with virologic failure), ESS30008 (n=260, virologic suppression on first-line therapy), and ARROW/COL105677 (n=1206, aged 3 months to 17 years).
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source
Source:
EMA
Date of first authorisation:
8 July 1999
Source URL:
Prevalence Source: