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Browsing by Author "Losina, Elena"
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Item Cost-effectiveness of first-line antiretroviral therapy for HIV-infected African children less than 3 years of age(Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2015-06-19) Ciaranello, Andrea L.; Doherty, Kathleen; Penazzato, Martina; Lindsey, Jane C.; Harrison, Linda; Kelly, Kathleen; Walensky, Rochelle P.; Essajee, Shaffiq; Losina, Elena; Muhe, Lulu; Wools-Kaloustian, Kara; Ayaya, Samuel; Weinstein, Milton C.; Palumbo, Paul; Freedberg, Kenneth A.; Department of Medicine, IU School of MedicineBACKGROUND: 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.Item Incidence of World Health Organization stage 3 and 4 events, tuberculosis and mortality in untreated, HIV-infected children enrolling in care before 1 year of age: an IeDEA (International Epidemiologic Databases To Evaluate AIDS) East Africa regional analysis(Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2014-06) Ciaranello, Andrea; Lu, Zhigang; Ayaya, Samuel; Losina, Elena; Musick, Beverly; Vreeman, Rachel; Freedberg, Kenneth A.; Abrams, Elaine J.; Dillabaugh, Lisa; Doherty, Katie; Ssali, John; Yiannoutsos, Constantin T.; Wools-Kaloustian, Kara; Department of Pediatrics, IU School of MedicineBACKGROUND: Few studies have reported CD4%- and age-stratified rates of World Health Organization Stage 3 (WHO3) events, World Health Organization Stage 4 (WHO4) events, tuberculosis (TB) and mortality in HIV-infected infants before initiation of antiretroviral therapy. METHODS: HIV-infected children enrolled before 1 year of age in the International Epidemiologic Databases to Evaluate AIDS East Africa region (October 1, 2002, to November, 2008) were included. We estimated incidence rates of earliest clinical event (WHO3, WHO4 and TB), before antiretroviral therapy initiation per local guidelines, stratified by current age (< or ≥6 months) and current CD4% (<15%, 15-24%, ≥25%). CD4%-stratified mortality rates were estimated separately for children who did not experience a clinical event ("background" mortality) and for children who experienced an event, including "acute" mortality (≤30 days post event) and "later" mortality (>30 days post event). RESULTS: Among 847 children (median enrollment age: 4.8 months; median pre-antiretroviral therapy follow up: 10.8 months; 603 (71%) with ≥1 CD4% recorded), event rates were comparable for those aged <6 and ≥6 months. Current CD4% was associated with risk of WHO4 events for children <6 months of age and with all evaluated events for children ≥6 months old (P < 0.05). "Background" mortality was 3.7-8.4/100 person-years (PY). "Acute" mortality (≤30 days post event) was 33.8/100 PY (after TB) and 41.1/100 PY (after WHO3 or WHO4). "Later" mortality (>30 days post event) ranged by CD4% from 4.7 to 29.1/100 PY. CONCLUSIONS: In treatment-naïve, HIV-infected infants, WHO3, WHO4 and TB events were common before and after 6 months of age and led to substantial increases in mortality. Early infant HIV diagnosis and treatment are critically important, regardless of CD4%.