When could new antiretrovirals be recommended for national treatment programmes in low-income and middle-income countries: results of a WHO Think Tank

PURPOSE OF REVIEW To discuss barriers and opportunities for the introduction of new antiretrovirals into national treatment programmes in low-income and middle-income countries to support further treatment scale-up. Invitees to a WHO Think Tank in February 2017 evaluated recently published results. RECENT FINDINGS There is not sufficient clinical experience of dolutegravir (DTG), tenofovir alafenamide (TAF) or efavirenz 400 mg (EFV400) to recommend their use in pregnancy. Outcomes from births and assessment of congenital anomalies need to be evaluated from several hundred pregnant women. Clinical experience of these treatments during rifampicin-based treatment for tuberculosis is also required. This could be difficult for TAF, which is currently contraindicated with TAF. Changes in second-line treatment from two nucleoside analogues + protease inhibitor plus ritonavir will require new randomized trials of alternative combinations. CONCLUSION Additional safety and efficacy data on DTG, TAF and EFV400 in some subpopulations are needed before a large introduction in national treatment programmes. There is currently limited support for the introduction of TAF as part of first-line antiretroviral treatment in low-income and middle-income settings. There was an overall agreement for 6-monthly reviews of safety and efficacy data, in parallel with a phased introduction of the new antiretrovirals.