ОТЧЕТ О ЗАКУПКАХ АРВ-ПРЕПАРАТОВ В 2015 ГОДУ:«ЗАКУПКИ АРВ-ПРЕПАРАТОВ В 2015 ГОДУ: ТЕОРИЯ ОТНОСИТЕЛЬНОСТИ. РЕЗУЛЬТАТЫ МОНИТОРИНГА ЗАКУПОК АРВ-ПРЕПАРАТОВ В РФ»

The main objective of the title document is to support the efforts of the authorities of the Russian Federation being undertaken to combat HIV epidemic. With account of dire epidemiological conditions and of ART drug deficit in Russia, the Coalition for Commitment to Therapy continuously monitors ART drugs purchasing and provision to HIV patients with the aims to analyze the situation and to work out recommendation for improving it. The report includes, among other things, answers to the following questions: What drugs for treating HIV were purchased in 2015 and at what amounts? What are the prices for specific ART drugs and is there a trend to their reduction? What is the estimated number of patients treatable with drugs purchased? What possible interventions can improve ART drugs provision to HIV patients?Основная цель этой публикации - оказать содействие усилиям властей Российской Федерации в борьбе против эпидемии ВИЧ-инфекции. Учитывая сложную эпидемиологическую обстановку и дефицит антиретровирусной терапии в РФ, «Коалиция по готовности к лечению» осуществляет непрерывный мониторинг закупок и предоставления антиретровирусных препаратов пациентам для анализа данных и выработки рекомендаций по улучшению ситуации. Отчет содержит, среди прочего, ответы на следущие вопросы: какие препараты для лечения ВИЧ-инфекции и в каком количестве закупались в 2015 году; каковы цены на отдельные антиретровирусные препараты, есть ли тенденция к их снижению по сравнению с предыдущими годами, каково расчетное количество пациентов, которые могли бы получать терапию в соответствии с данными по закупкам препаратов; каковы возможные меры для улучшения ситуации с обеспечением антиретровирусной терапией

Enhanced infection prophylaxis reduces mortality in severely immunosuppressed HIV-infected adults and older children initiating antiretroviral therapy in Kenya, Malawi, Uganda and Zimbabwe: the REALITY trial

Meeting abstract FRAB0101LB from 21st International AIDS Conference 18–22 July 2016, Durban, South Africa. Introduction: Mortality from infections is high in the first 6 months of antiretroviral therapy (ART) among HIV‐infected adults and children with advanced disease in sub‐Saharan Africa. Whether an enhanced package of infection prophylaxis at ART initiation would reduce mortality is unknown. Methods: The REALITY 2×2×2 factorial open‐label trial (ISRCTN43622374) randomized ART‐naïve HIV‐infected adults and children >5 years with CD4 <100 cells/mm3. This randomization compared initiating ART with enhanced prophylaxis (continuous cotrimoxazole plus 12 weeks isoniazid/pyridoxine (anti‐tuberculosis) and fluconazole (anti‐cryptococcal/candida), 5 days azithromycin (anti‐bacterial/protozoal) and single‐dose albendazole (anti‐helminth)), versus standard‐of‐care cotrimoxazole. Isoniazid/pyridoxine/cotrimoxazole was formulated as a scored fixed‐dose combination. Two other randomizations investigated 12‐week adjunctive raltegravir or supplementary food. The primary endpoint was 24‐week mortality. Results: 1805 eligible adults (n = 1733; 96.0%) and children/adolescents (n = 72; 4.0%) (median 36 years; 53.2% male) were randomized to enhanced (n = 906) or standard prophylaxis (n = 899) and followed for 48 weeks (3.8% loss‐to‐follow‐up). Median baseline CD4 was 36 cells/mm3 (IQR: 16–62) but 47.3% were WHO Stage 1/2. 80 (8.9%) enhanced versus 108(12.2%) standard prophylaxis died before 24 weeks (adjusted hazard ratio (aHR) = 0.73 (95% CI: 0.54–0.97) p = 0.03; Figure 1) and 98(11.0%) versus 127(14.4%) respectively died before 48 weeks (aHR = 0.75 (0.58–0.98) p = 0.04), with no evidence of interaction with the two other randomizations (p > 0.8). Enhanced prophylaxis significantly reduced incidence of tuberculosis (p = 0.02), cryptococcal disease (p = 0.01), oral/oesophageal candidiasis (p = 0.02), deaths of unknown cause (p = 0.02) and (marginally) hospitalisations (p = 0.06) but not presumed severe bacterial infections (p = 0.38). Serious and grade 4 adverse events were marginally less common with enhanced prophylaxis (p = 0.06). CD4 increases and VL suppression were similar between groups (p > 0.2). Conclusions: Enhanced infection prophylaxis at ART initiation reduces early mortality by 25% among HIV‐infected adults and children with advanced disease. The pill burden did not adversely affect VL suppression. Policy makers should consider adopting and implementing this low‐cost broad infection prevention package which could save 3.3 lives for every 100 individuals treated