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ATC codes: J05AR02
EMLc
Indication
Human immunodeficiency virus disease without mention of associated disease or condition, clinical stage unspecified ICD11 code: 1C62.Z
INN
Abacavir + lamivudine
Medicine type
Chemical agent
List type
Core
Formulations
Oral > Solid: 120 mg (as sulfate) + 60 mg tablet (dispersible, scored)
EML status history
First added in 2015 (TRS 994)
Changed in 2017 (TRS 1006)
Changed in 2019 (TRS 1021)
Sex
All
Age
Also recommended for children
Therapeutic equivalence
The recommendation is for this specific medicine
Patent information
Main patent is active in several jurisdictions. For more information on specific patents and license status for developing countries visit www.MedsPal.org
Summary of evidence and Expert Committee recommendations
The Committee recommended deletion of abacavir + lamivudine 60 mg + 30 mg dispersible scored tablet from the EML and EMLc, noting that this formulation is no longer included in the current WHO guidelines for paediatric HIV treatment, and that suitable alternatives are already included on the Model Lists and available for use. Abacavir + lamivudine 120 mg + 60 mg scored dispersible tablets remain included on the Model Lists. Recommendations were made by the WHO HIV Department to delete the antiretroviral formulations from the EML and EMLc in order to achieve alignment between the 2018 WHO interim guidelines for antiretroviral regimens (1), and The 2018 optimal formulary and limited-use list for paediatric ARVs (2). Abacavir + lamivudine (ABC/3TC) 60 mg + 30 mg dispersible scored tablet was removed from the latest optimal formulary. It has been replaced with ABC/3TC 120 mg + 60 mg dispersible scored tablet to minimize market fragmentation while decreasing pill burden for older children. The double strength formulation was included on the EML and EMLc in 2017. References: 1. Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV: interim guidelines, supplement to the 2016 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. World Health Organization, Geneva. December, 2018. Available from https://apps.who.int/iris/bitstream/handle/10665/277395/WHO-CDS-HIV-18.51-eng.pdf?ua=1, accessed 26 September 2019. 2. The 2018 optimal formulary and limited-use list for paediatric ARVs. Geneva, Switzerland: World Health Organization; 2018. Available from http://apps.who.int/iris/bitstream/handle/10665/273153/WHO-CDS-HIV-18.15-eng.pdf?ua=1, accessed 26 September 2019.