ATC codes: J05AG03
Human immunodeficiency virus disease without mention of associated disease or condition, clinical stage unspecified ICD11 code: 1C62.Z
Oral > Solid: 600 mg tablet (EML) ; 200 mg scored tablet
EML status history
Also recommended for children
> 3 years old
> 10 Kg
The recommendation is for this specific medicine
Expert Committee recommendation
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, efavirenz capsules 50 mg, 100 mg and 200 mg, stavudine capsules 15 mg, 20 mg and 30 mg and powder for oral liquid 5 mg/mL, and zidovudine capsules 100 mg. Noting the advice from the WHO Department of HIV/AIDS about the continued recommendation in current WHO guidelines for use of lamivudine oral liquid for the treatment of newborns, the Expert Committee recommended that it be deleted from the EML but retained on the EMLc. The Committee considered the rationale behind the new proposals to delete atazanavir, lamivudine + nevirapine + stavudine, nevirapine and saquinavir formulations to be reasonable and therefore recommended deletion of the items as proposed. In the case of zidovudine solution for IV infusion injection, the Committee noted that, although not included in current WHO HIV guidelines, it is still recommended by a number of other international guidelines for HIV-positive women who have viral loads greater than 1000 copies/mL and are therefore considered to be at high risk for maternal-to-newborn HIV transmission. The Committee therefore recommended zidovudine solution for IV infusion injection be retained on the EML for the subset of HIV-positive pregnant patients who are at high risk of transmitting the infection to their newborns.
The 2015 Expert Committee recommended deletion from the EML and EMLc in 2017 of the following medicines without further discussion unless an application was received to support their retention (1). - abacavir Oral liquid: 100 mg (as sulfate)/5 mL - efavirenz Capsule: 50 mg, 100 mg, 200 mg - lamivudine Oral liquid: 50 mg/mL - stavudine Capsule: 15 mg; 20 mg; 30 mg and powder for oral liquid: 5 mg/mL - zidovudine Capsule: 100 mg
Public health relevance
The rationale provided in the application for the requested new deletions fell into three categories, described below: ■■ Category 1: exclusion of the medicine as a therapeutic option in current guidelines. The medicine is in the current EML/EMLc and is not recommended as a therapeutic option in the 2016 WHO Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. ■■ Category 2: exclusion of the formulation as a therapeutic option in current guidelines. Dose in the current EML is not aligned with the recommended dosing in the 2016 WHO Consolidated guidelines. ■■ Category 3: provide alignment with the optimal Formulary of the Interagency Task Team (IATT) on Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Their Children (3). The application from Roche stated that clinical use of the protease inhibitor saquinavir has declined over time with the introduction of newer antiretroviral agents with lower pill burden, similar or greater effectiveness and lower risk of toxicity. Unlike other protease inhibitors, saquinavir is associated with QT prolongation and a requirement for ECG monitoring. Numerous alternative protease inhibitors (with and without ritonavir) remain listed on the EML.
Cost / cost effectiveness
The proposed deletions are in alignment with recommendations in the 2016 WHO Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection and with the IATT Paediatric ARV Formulary, revised in 2016.
In consideration of the consequences of the proposed deletions: ■■ atazanavir: 100 mg remains available on EML and EMLc, 300 mg remains available on EML; an FDC formulation of atazanavir + ritonavir (300 mg + 100 mg) has been added to the EML in 2017. ■■ lamivudine + nevirapine + stavudine: deletion will remove all available formulations from the EML/EMLc of this FDC. ■■ nevirapine: 200-mg tablets remain on the EML; the EMLc includes oral liquid 50 mg/mL and 50-mg dispersible tablets. ■■ saquinavir: numerous alternative protease inhibitors (with and without ritonavir in FDCs) are available on the EML. ■■ zidovudine: currently the only HIV medicine on the EML that comes in a parenteral dose form; multiple alternative oral dose forms of zidovudine are available, including in FDCs.
With the exception of the request from the WHO Department of HIV/AIDS to retain lamivudine oral liquid on the EMLc, no applications were received to support retention of any of the medicines flagged for deletion in 2015.
1. The selection and use of essential medicines. Report of the WHO Expert Committee, 2015 (including the 19th WHO Model List of Essential Medicines and the 5th WHO Model List of Essential Medicines for Children). Geneva: World Health Organization; 2015 (WHO Technical Report Series, No. 994). 2. 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 19 January 2017). 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 19 January 2017).