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ATC codes: J05AF06
EMLc
Indication
Human immunodeficiency virus disease without mention of associated disease or condition, clinical stage unspecified ICD11 code: 1C62.Z
INN
Abacavir
Medicine type
Chemical agent
List type
Core
Formulations
Oral > Solid: 60 mg tablet (dispersible, scored) (as sulfate) (EMLc) ; 300 mg tablet (as sulfate) (EML)
EML status history
First added in 2002 (TRS 914)
Changed in 2007 (TRS 950)
Changed in 2015 (TRS 994)
Changed in 2017 (TRS 1006)
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
Wikipedia
DrugBank
Expert Committee recommendation
Taking into account the recommendations for abacavir in current WHO HIV treatment guidelines and the decision taken in parallel at this meeting to delete abacavir oral liquid from the EML and EMLc, the Expert Committee recommended the addition of the proposed 60-mg dispersible, scored tablet formulation of abacavir to the core list of the EMLc, noting the importance of the availability of effective, age-appropriate paediatric dosage forms of antiretroviral medicines. In a separate recommendation at this meeting, recalling the recommendation from the 2015 meeting, the Expert Committee recommended the deletion from the EML and EMLc of abacavir oral liquid 100 mg/5 mL formulation.
Background
Abacavir has been included on the EMLc since 2007. Evidence for effectiveness and safety was evaluated at the time of listing. Abacavir (ABC) oral liquid 100 mg/5 mL is currently the only formulation of abacavir included on the 5th EMLc (2015). It has been proposed for deletion in 2017 in accordance with the 2015 Expert Committee recommendation.
Public health relevance
There were 150 000 new paediatric HIV infections in 2015, and 1.8 million children are now living with HIV (1). There is evidence that, without antiretroviral treatment (ART), more than 50% of infected infants will progress to AIDS and death by age 2 years (2). Age-appropriate dosage forms for use in infants and children are necessary for the successful scaling-up of treatment for paediatric HIV infection.
Benefits
Evidence for the clinical effectiveness of abacavir was evaluated at the time of listing. Abacavir 60-mg dispersible, scored tablets are included on the “Limited Use” paediatric ARV formulary list of the Interagency Task Team (IATT) on Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and their Children for use in children under 3 years of age who are undergoing tuberculosis treatment and require a triple nucleoside ART (3). The application described a review of abacavir use in paediatric patients which found that there was benefit, in terms of increased antiretroviral activity, of a triple nucleoside reverse transcriptase inhibitor (NRTI) regimen containing zidovudine, lamivudine and abacavir compared with zidovudine, lamivudine and placebo (4). The application also described findings of the ARROW study: viral load suppression was similar to standard non-nucleoside reverse transcriptase inhibitor (NNRTI)-based ART at 48 weeks for children coinfected with TB who moved to a triple-NRTI regimen containing abacavir, and was significantly lower at 144 weeks (5). Advantages of dispersible tablet formulations over syrups include ease of transport and lower transport and production costs; they can be used for very young children and may be dispersed in breast milk or formula. Scored tablets provide flexibility of dosing across age and weight ranges.
Harms
Evidence for the safety of abacavir was evaluated at the time of listing.
Additional evidence
N/A
Cost / cost effectiveness
The average reported price per patient per year for abacavir dispersible tablets is US$ 95 compared with US$135 for abacavir oral liquid. The application also claimed savings in terms of reduced shipment, storage and wastage costs compared with oral liquid.
WHO guidelines
Abacavir is recommended in the 2016 WHO Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection as part of the NRTI backbone for infants and children under 3 years of age (strong recommendation, moderate-quality evidence). Abacavir is also a recommended option as part of the NRTI backbone for first-line ART in children aged 3–10 years (conditional recommendation, moderate-quality evidence). It is also recommended as part of triple NRTI treatment for children who develop TB while on an ART regimen containing nevirapine or ritonavir-boosted lopinavir (strong recommendation, moderate-quality evidence) (6).
Availability
Abacavir 60 mg dispersible tablets are included on the WHO List of Prequalified Medicinal Products. They are produced by Cipla Limited and Micro Labs Limited, India.
Other considerations
In 2015, abacavir 300 mg tablets were removed from the EMLc. The Committee considered the rationale justifying deletion was reasonable, namely, that it was appropriate to exclude adult formulations from the EMLc and to promote full alignment with the recommendations of the Inter-Agency Task Team (IATT) on Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and their Children, to simplify the EMLc and avoid overlap with the EML. Additionally in 2017, recalling the recommendation from the 2015 Expert Committee meeting, the Expert Committee recommended the deletion from the EML and EMLc of abacavir oral liquid 100 mg/5 mL.
Implementation considerations
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1. AIDS by the numbers – AIDS is not over, but it can be. Geneva: Joint United Nations Programme on HIV/AIDS; 2016 (http://www.unaids.org/en/resources/documents/2016/AIDS-by-the-numbers, accessed 25 January 2017). 2. Newell ML, Coovadia H, Cortina-Borja M, Rollins N, Gaillard P, Dabis F. Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis. Lancet. 2004;364(9441):1236–43. 3. Policy Brief: IATT Paediatric ARV Formulary and Limited-Use List: 2016 update. Interagency Task Team (IATT) for Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children; 2016 (http://emtct-iatt.org/wp-content/uploads/2016/10/Updated-Ped-ARV-Formulary-List-5-Sept-2016-1.pdf, accessed 25 January 2017). 4. Melroy J, Nair V. The antiviral activity, mechanism of action, clinical significance and resistance of abacavir in the treatment of pediatric AIDS. Curr Pharm Des. 2005;11(29):3847–52. 5. Kekitiinwa A, Cook A, Nathoo K, Mugyenyi P, Nahirya-Ntege P, Bakeera-Kitaka S et al. Routine versus clinically driven laboratory monitoring and first-line antiretroviral therapy strategies in African children with HIV (ARROW): a 5-year open-label randomised factorial trial. Lancet. 2013;381(9875):1391–403. 6. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach, second edition. Geneva: World Health Organization; 2016 (http://www.who.int/hiv/pub/arv/arv-2016/en/, accessed 25 January 2017).