Abacavir; Lamivudine; Zidovudine
abacavir-lamivudine-zidovudine is an antiviral combination for treatment of HIV infection in adults after HLA-B*5701 screening.
Source:
EMA
Active Ingredients:
Indications
Representation
No sex-specific representation data
Efficacy
No sex-specific efficacy data
Posology
No sex-specific posology data
Potential Side Effects
Sex differences in potential side effects
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-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific differences in possible side effects
Sex differences in data
Rare gynaecomastia is reported.
Lactic acidosis is noted as more likely in obese people, especially women.
Pregnancy / lactation
N / A
There are no data on the fixed combination in pregnancy. Clinical experience with abacavir, lamivudine, and zidovudine in combination indicates no malformative toxicity, and zidovudine with newborn treatment has reduced maternal-foetal HIV transmission. Women living with HIV are advised not to breast-feed to avoid transmission; abacavir is excreted into human milk, lamivudine infant serum levels are very low, and zidovudine concentrations in human milk are similar to serum after a single dose.
Sex-specific non-clinical findings
Animal studies showed no effect on male fertility for abacavir, lamivudine, or zidovudine; zidovudine did not affect sperm number, morphology, or motility in men.
Animal studies showed no effect on female fertility for abacavir, lamivudine, or zidovudine.
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-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific posology
No sex-specific data
No sex-specific data were reported in the evaluated sources.
Sex-specific differences in possible side effects
Sex differences in data
Men
Rare gynaecomastia is reported.
Women
Lactic acidosis is noted as more likely in obese people, especially women.
Pregnancy / lactation
Men
N / A
Women
There are no data on the fixed combination in pregnancy. Clinical experience with abacavir, lamivudine, and zidovudine in combination indicates no malformative toxicity, and zidovudine with newborn treatment has reduced maternal-foetal HIV transmission. Women living with HIV are advised not to breast-feed to avoid transmission; abacavir is excreted into human milk, lamivudine infant serum levels are very low, and zidovudine concentrations in human milk are similar to serum after a single dose.
Sex-specific non-clinical findings
Men
Animal studies showed no effect on male fertility for abacavir, lamivudine, or zidovudine; zidovudine did not affect sperm number, morphology, or motility in men.
Women
Animal studies showed no effect on female fertility for abacavir, lamivudine, or zidovudine.
General information
General Efficacy
Primary endpoints: Virologic efficacy was established using viral load-based endpoints: proportion of patients with undetectable viral load (≤400 copies/mL), virological failure defined as HIV RNA >200 copies/mL, and virologic success defined as HIV RNA <50 copies/mL at week 48. Secondary endpoints: Supportive efficacy measures included time to first virologic failure, subgroup analyses by baseline viral load (>100,000 copies/mL), intention-to-treat and as-treated proportions with undetectable viral load, and 24-week proportions with viral load <400 and <50 copies/mL in a pilot study.
General Posology
One tablet orally twice daily in adults (18 years and over); it may be taken with or without food. If dose reduction or discontinuation of one component is required, separate abacavir, lamivudine, and zidovudine products should be used.
Further Dose Adjustments
The fixed-dose combination is contraindicated in end-stage renal disease and in patients with abnormally low neutrophil counts or haemoglobin; it is not recommended in moderate or severe hepatic impairment unless judged necessary. If dose reduction or discontinuation of an individual component is required, separate abacavir, lamivudine, and zidovudine products should be used.
Possible Side Effects
Very common adverse reactions were headache and nausea. Serious reactions included abacavir hypersensitivity, zidovudine-associated anaemia/neutropenia/leukopenia, lactic acidosis that could be fatal, and lipoatrophy; treatment should be stopped if hypersensitivity is suspected and should not be continued if lipoatrophy develops.
Contraindications
Hypersensitivity to abacavir, lamivudine, zidovudine, or excipients; end-stage renal disease; abnormally low neutrophil counts (<0.75 x 10^9/l) or haemoglobin (<7.5 g/dl or 4.65 mmol/l).
Clinical Trial Type and Population
Clinical efficacy was evaluated mainly in adults with HIV-1 infection who were treatment naive, with supporting evidence in moderately antiretroviral-experienced patients with non-advanced disease. Major studies reported were an unnamed randomized, double-blind, placebo-controlled study in treatment-naive patients (sample size not reported; mean/median age not reported; women not reported) and ACTG5095 (n=1147 antiretroviral-naïve HIV-1 infected adults; mean/median age not reported; women not reported).
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source
Source:
EMA
Source URL:
Prevalence Source: