Ciaranello, Andrea L.Doherty, KathleenPenazzato, MartinaLindsey, Jane C.Harrison, LindaKelly, KathleenWalensky, Rochelle P.Essajee, ShaffiqLosina, ElenaMuhe, LuluWools-Kaloustian, KaraAyaya, SamuelWeinstein, Milton C.Palumbo, PaulFreedberg, Kenneth A.2016-03-312016-03-312015-06-19Ciaranello, A. L., Doherty, K., Penazzato, M., Lindsey, J. C., Harrison, L., Kelly, K., … Freedberg, K. A. (2015). Cost-effectiveness of first-line antiretroviral therapy for HIV-infected African children less than 3 years of age. AIDS (London, England), 29(10), 1247–1259. http://doi.org/10.1097/QAD.00000000000006721473-5571https://hdl.handle.net/1805/9156BACKGROUND: The International Maternal, Pediatric, and Adolescent Clinical Trials P1060 trial demonstrated superior outcomes for HIV-infected children less than 3 years old initiating antiretroviral therapy (ART) with lopinavir/ritonavir compared to nevirapine, but lopinavir/ritonavir is four-fold costlier. DESIGN/METHODS: We used the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-Pediatric model, with published and P1060 data, to project outcomes under three strategies: no ART; first-line nevirapine (with second-line lopinavir/ritonavir); and first-line lopinavir/ritonavir (second-line nevirapine). The base-case examined South African children initiating ART at age 12 months; sensitivity analyses varied all key model parameters. Outcomes included life expectancy, lifetime costs, and incremental cost-effectiveness ratios [ICERs; dollars/year of life saved ($/YLS)]. We considered interventions with ICERs less than 1× per-capita gross domestic product (South Africa: $7500)/YLS as 'very cost-effective,' interventions with ICERs below 3× gross domestic product/YLS as 'cost-effective,' and interventions leading to longer life expectancy and lower lifetime costs as 'cost-saving'. RESULTS: Projected life expectancy was 2.8 years with no ART. Both ART regimens markedly improved life expectancy and were very cost-effective, compared to no ART. First-line lopinavir/ritonavir led to longer life expectancy (28.8 years) and lower lifetime costs ($41 350/person, from lower second-line costs) than first-line nevirapine (27.6 years, $44 030). First-line lopinavir/ritonavir remained cost-saving or very cost-effective compared to first-line nevirapine unless: liquid lopinavir/ritonavir led to two-fold higher virologic failure rates or 15-fold greater costs than in the base-case, or second-line ART following first-line lopinavir/ritonavir was very ineffective. CONCLUSIONS: On the basis of P1060 data, first-line lopinavir/ritonavir leads to longer life expectancy and is cost-saving or very cost-effective compared to first-line nevirapine. This supports WHO guidelines, but increasing access to pediatric ART is critical regardless of the regimen used.en-USAttribution-NonCommercial-NoDerivatives 4.0 InternationalAnti-Retroviral Agentseconomicstherapeutic useAntiretroviral Therapy, Highly ActivemethodsHIV Infectionsdrug therapyArticle