Use of generic antiretroviral agents and cost savings in PEPFAR treatment programs.

CONTEXT: One of the biggest hurdles to the rapid scale-up of antiretroviral therapy in the developing world was the price of antiretroviral drugs (ARVs). Modification of an existing US Food and Drug Administration (FDA) process to expedite review and approval of generic ARVs quickly resulted in a large number of FDA-tentatively approved ARVs available for use by the US President's Emergency Plan for AIDS Relief (PEPFAR). OBJECTIVE: To evaluate the uptake of generic ARVs among PEPFAR-supported programs in Guyana, Haiti, Vietnam, and 13 countries in Africa, and changes over time in ARV use and costs. DESIGN, SETTING, AND PARTICIPANTS: An annual survey from 2005 to 2008 of ARVs purchased in 16 countries by PEPFAR implementing and procurement partners (organizations using PEPFAR funding to purchase ARVs). MAIN OUTCOME MEASURES: Drug expenditures, ARV types and volumes (assessed per pack, a 1-month supply), proportion of generic procurement across years and countries, and cost savings from generic procurement. RESULTS: ARV expenditures increased from $116.8 million (2005) to $202.2 million (2008); and procurement increased from 6.2 million to 22.1 million monthly packs. The proportion spent on generic ARVs increased from 9.17% (95% confidence interval [CI], 9.17%-9.18%) in 2005 to 76.41% (95% CI, 76.41%-76.42%) in 2008 (P < .001), and the proportion of generic packs procured increased from 14.8% (95% CI, 14.79%-14.84%) in 2005 to 89.33% (95% CI, 89.32%-89.34%) in 2008 (P < .001). In 2008, there were 8 PEPFAR programs that procured at least 90.0% of ARV packs in generic form; South Africa had the lowest generic procurement (24.7%; 95% CI, 24.6%-24.8%). Procurement of generic fixed-dose combinations increased from 33.3% (95% CI, 33.24%-33.43%) in 2005 to 42.73% (95% CI, 42.71%-42.75%) in 2008. Estimated yearly savings generated through generic ARV use were $8,108,444 in 2005, $24,940,014 in 2006, $75,645,816 in 2007, and $214,648,982 in 2008, a total estimated savings of $323,343,256. CONCLUSION: Among PEPFAR-supported programs in 16 countries, availability of generic ARVs was associated with increased ARV procurement and substantial estimated cost savings.

Have geopolitics influenced decisions on American health foreign assistance efforts during the Obama presidency?

BACKGROUND: This study sought to characterize the possible relationship between US geopolitical priorities and annual decisions on health foreign assistance among recipient nations between 2009 and 2016. METHODS: Data on total planned United States (US) foreign aid and health aid were collected for the 194 member nations of the World Health Organization (WHO) from publicly available databases. Trends in per-capita spending were examined between 2009 and 2016 across the six regions of the WHO (Africa, Americas, Eastern Mediterranean, Europe, Southeast Asia, and the Western Pacific). Data on US national security threats were obtained from the Council on Foreign Relations' annual Preventive Priorities Survey. Multivariable regression models were fitted specifying planned health aid as the dependent variable and threat level of a recipient aid nation as the primary independent variable. RESULTS: Across the aggregate 80 planned recipient countries of US health aid over the duration of the study period, cumulative planned per-capita spending was stable (US$ 0.65 in both 2009 and 2016). The number of annual planned recipients of this aid declined from 74 in 2009 to 56 in 2016 (24.3% decline), with planned allocations decreasing in the Americas, Eastern Mediterranean, and Europe; corresponding increases were observed in Africa, Southeast Asia, and the Western Pacific. Regression analyses demonstrated a dose-response, whereby higher levels of threat were associated with larger declines in planned spending (critical threat nations: b = -3.81; 95% confidence interval (CI) -5.84 to -1.78, P ≤ 0.001) and one-year lagged (critical threat nations: b = -3.91; 95% CI, -5.94 to -1.88, P ≤ 0.001) analyses. CONCLUSIONS: Higher threat levels are associated with less health aid. This is a novel finding, as prior studies have demonstrated a strong association between national security considerations and decisions on development aid.

Health impact of human rights testimony: harming the most vulnerable?

BACKGROUND: Current legal efforts to document human rights violations typically include interviews in which survivors are asked to provide detailed descriptions of their traumatic experiences during a single meeting. Research on similar interview techniques used as part of a mental health treatment (eg, debriefing) has raised concerns that they might worsen mental health-more than doubling the risk of post-traumatic stress disorder in some studies. While controversy over the mental health impact of debriefing continues, debriefing treatments have been discontinued in most clinics nearly 2 decades ago. The purpose of this article is to promote the development and integration of preventative measures to limit potential mental health damage associated with legal endeavours to address human rights violations and international crimes. METHODS AND FINDINGS: Given the recent growth of the field of global mental health and its current capacity to provide feasible, acceptable, effective care in low-resource settings, we propose a research agenda to identify the mental health impact of current human rights legal practices and test a model of scalable medicolegal care that minimises risk by integrating mental health monitoring and applying up-to-date models of trauma treatment, including multiple meeting sessions, as indicated. CONCLUSIONS: As the fields of global health, human rights law, international criminal law and transitional justice increasingly overlap in their efforts to assist communities affected by grave violence, we propose that synchronising efforts may offer important opportunities to improve mental health for survivors.

The Medical and Nursing Education Partnership Initiatives.

The Medical Education Partnership Initiative (MEPI) and Nursing Education Partnership Initiative (NEPI) are innovative approaches to strengthening the academic and clinical training of physicians and nurses in Sub-Saharan African countries, which are heavily burdened by HIV/AIDS. Begun in 2010 by the U.S. President's Emergency Plan for AIDS Relief with the National Institutes of Health, investments in curricula, innovative learning technologies, clinical mentoring, and research opportunities are providing a strong base to advance high-quality education for growing numbers of urgently needed new physicians and nurses in these countries. The MEPI and NEPI focus on strengthening learning institutions is central to the vision for expanding the pool of health professionals to meet the full range of a country's health needs. A robust network of exchange between education institutions and training facilities, both within and across countries, is transforming the quality of medical education and augmenting a platform for research opportunities for faculty and clinicians, which also serves as an incentive to retain professionals in the country. Excellence in patient care and a spirit of professionalism, core to MEPI and NEPI, provide a strong foundation for the planning and delivery of health services in participating countries.

PEPFAR's past and future efforts to cut costs, improve efficiency, and increase the impact of global HIV programs.

Amid the global economic crisis, the President's Emergency Plan for AIDS Relief (PEPFAR) and other organizations have been pressed to do more with constrained resources to meet unmet needs in the worldwide HIV/AIDS pandemic. PEPFAR has approached this challenge through the development of an Impact and Efficiency Acceleration Plan, which includes improving the collection and use of economic and financial data, increasing the efficiency of HIV/AIDS program implementation, and collaborating with governments and multilateral organizations to maximize the impact of the resources provided by the United States. For example, by linking financial data with program outputs, PEPFAR was able to help its implementing partners in Mozambique reduce mean unit expenditures for people receiving antiretroviral treatment by 45 percent, from $265 to $145 per person, between 2009 and 2011. This article describes the plan's elements, provides examples of progress and challenges to its implementation, and assesses the prospects for further improvements in efficiency and impact.

The Chinese free antiretroviral treatment program: challenges and responses.

To respond to the HIV/AIDS epidemic in China, the National Center for AIDS/STD Control and Prevention established the Division of Treatment and Care in late 2001. The pilot for the National Free ART Program began in Henan Province in 2002, and the program fully began in 2003. Treatment efforts initially focused on patients infected through illicit blood and plasma donation in the mid-1990s and subsequently expanded to include HIV-infected injection drug users, commercial sex workers, pregnant women, and children. The National Free ART Database was established in late 2004, and includes data on current patients and those treated before 2004. Over 31 000 adult and pediatric patients have been treated thus far. Challenges for the program include integration of drug treatment services with ART, an under-resourced health care system, co-infections, stigma, discrimination, drug resistance, and procurement of second-line ART. The merging of national treatment and care, epidemiologic, and drug resistance databases will be critical for a better understanding of the epidemic, for earlier identification of patients requiring ART, and for improved patient follow-up. The Free ART Program has made considerable progress in providing the necessary care and treatment for HIV-infected people in China and has strong government support for continued improvement and expansion.