Abacavir; Lamivudine
abacavir-lamivudine is an antiretroviral combination for treatment of HIV infection in adults, adolescents, and children weighing at least 25 kg.
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
45.7%
54.3%
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
No significant sex-related difference in efficacy was reported; in the ARROW paediatric study, subgroup analyses found no significant effect of sex on the comparison between once- and twice-daily dosing.
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
During pregnancy, use should be considered in light of animal and human data. There are no pregnancy data for the fixed-dose combination, but human exposure data for the individual components indicate no malformative or foetal/neonatal effect; both components cross the placenta. Abacavir is excreted into human milk, lamivudine exposure in breastfed infants is very low, and women living with HIV are recommended not to breast-feed to avoid HIV transmission.
Sex-specific non-clinical findings
In rat fertility studies, abacavir and lamivudine had no effect on male fertility.
In rat fertility studies, abacavir and lamivudine had no effect on female fertility.
Disease prevalence by sex
Men
45.7%
Women
54.3%
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
No significant sex-related difference in efficacy was reported; in the ARROW paediatric study, subgroup analyses found no significant effect of sex on the comparison between once- and twice-daily dosing.
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
During pregnancy, use should be considered in light of animal and human data. There are no pregnancy data for the fixed-dose combination, but human exposure data for the individual components indicate no malformative or foetal/neonatal effect; both components cross the placenta. Abacavir is excreted into human milk, lamivudine exposure in breastfed infants is very low, and women living with HIV are recommended not to breast-feed to avoid HIV transmission.
Sex-specific non-clinical findings
Men
In rat fertility studies, abacavir and lamivudine had no effect on male fertility.
Women
In rat fertility studies, abacavir and lamivudine had no effect on female fertility.
General information
General Efficacy
Primary endpoints: Primary efficacy was established mainly by virologic suppression or response endpoints: proportion with plasma HIV-1 RNA <50 copies/mL at Week 48 (and continued Week 96 analyses in some studies), assessment of virological failure in ACTG5202, average area under the curve minus baseline for HIV-1 RNA in CAL30001, and in the paediatric ARROW study the proportion with HIV-1 RNA <80 c/mL at Week 48. Secondary endpoints: Supportive endpoints included >1 log reduction in HIV RNA or achievement of <50 copies/mL, response analyses by baseline HIV-1 RNA and CD4 categories, proportions with HIV-1 RNA <400 copies/mL, Week 96 virologic outcomes, and in ARROW suppression thresholds of <200, <400 and <1000 c/mL.
General Posology
abacavir-lamivudine 600 mg/300 mg: one tablet orally once daily in adults, adolescents and children weighing at least 25 kg; it may be taken with or without food. The fixed-dose tablet should not be used in children weighing under 25 kg and is not suitable when dose adjustment of an individual component is required.
Further Dose Adjustments
Do not initiate in patients with positive HLA-B*5701 status or with a previous suspected abacavir hypersensitivity reaction on an abacavir-containing regimen.
Possible Side Effects
Common adverse reactions included hypersensitivity, anorexia, headache, nausea, vomiting, diarrhoea, cough or nasal symptoms, rash, arthralgia, muscle disorders, fever, lethargy, fatigue, insomnia, abdominal pain or cramps, malaise and alopecia. Serious reactions included abacavir hypersensitivity, which can be life-threatening or fatal, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, lactic acidosis, hepatitis, pancreatitis, angioedema, rhabdomyolysis and osteonecrosis. Suspected abacavir hypersensitivity requires immediate discontinuation and abacavir must not be restarted.
Contraindications
Hypersensitivity to abacavir, lamivudine, or any excipients; the medication 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 abacavir hypersensitivity reaction on a previous abacavir-containing regimen.
Clinical Trial Type and Population
Clinical efficacy was evaluated mainly in treatment-naïve and treatment-experienced HIV-infected patients, plus one paediatric HIV study; mean/median age and the percentage of women/girls were generally not reported in this document. CNA30021: therapy-naïve adults, n=770, mean/median age not reported, women not reported. EPZ104057 (HEAT): therapy-naïve adults, n=688 total (343 and 345 arms), mean/median age not reported, women not reported. ACTG5202: treatment-naïve HIV-1-infected patients, sample size/age/women not reported in this document. CNA109586 (ASSERT): ART-naïve, HLA-B*5701-negative HIV-1-infected adults, n=385 total (192 and 193 arms), mean/median age not reported, women not reported. CAL30001: treatment-experienced patients with virologic failure, n=182, mean/median age not reported, women not reported. ESS30008: patients with virologic suppression on first-line therapy, n=260, mean/median age not reported, women not reported. ARROW (COL105677): paediatric patients aged 3 months to 17 years, n=1206 enrolled and 669 randomized; girls not reported.
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source
Source:
EMA
Source URL:
Prevalence Source: