Table 1.
Study | Key findings |
---|---|
ODYSSEY | The Dolutegravir 50 mg film-coated tablet is safe and efficacious with similar bioavailability to adults when used in children above 20 kg than lower dose formulations. |
IMPAACT P1093 | Dolutegravir was well tolerated and safe among adolescents through 153 weeks of follow-up. |
LOLIPOP | Fixed-dose combination granules of abacavir, lamivudine, and Lopinavir/ritonavir (4 in 1 formulation called quadrimmune) is safe and effective in achieving or maintaining viral suppression, produces good drug exposure, and is more acceptable than Lopinavir/ritonavir pellets or other previous formulations. |
GS-US-292-0106 | Once daily single-tablet coformulation of 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 10 mg tenofovir alafenamide maintained viral suppression and was safe in 24 weeks of follow-up among children 6–11 years. |
GS-9883/F/TAF | Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg was safe, acceptable, and maintained viral suppression through 96 weeks of follow-up among children and adolescents aged 6–18 years (⩾25 kg). |
REALITY | An enhanced prophylaxis package (12 weeks of fluconazole 100 mg daily), 12 weeks of fixed-dose combination of co-trimoxazole, isoniazid, and pyridoxine as a once daily tablet, 5 days of azithromycin and a single dose of albendazole enhanced prophylaxis package reduced mortality by 27% over 24 weeks compared to standard of care (co-trimoxazole) according to national guidelines. Ready-to-use supplementary food did not reduce early mortality. |
SMILE | Once daily integrase inhibitors plus darunavir/ritonavir was noninferior to standard of care triple ART and was equally safe among virologically children aged 6–18 years. |
ART, antiretroviral therapy.