Massimo Ghidinelli

Health outcomes and cost impact of the new WHO 2013 guidelines on prevention of mother-to-child transmission of HIV in Zambia.

Background Countries are currently progressing towards the elimination of new paediatric HIV infections by 2015. WHO published new consolidated guidelines in June 2013, which now recommend either ‘Antiretroviral drugs (ARVs) for women living with HIV during pregnancy and breastfeeding (Option B)’ or ‘Lifelong antiretroviral therapy (ART) for all pregnant and breastfeeding women living with HIV (Option B+)’, while de facto phasing out Option A. This study examined health outcomes and cost impact of the shift to WHO 2013 recommendations in Zambia. Methods A decision analytic model was developed based on the national health system perspective. Estimated risk and number of cases of HIV transmission to infants and to serodiscordant partners, and proportions of HIV-infected pregnant women with CD4 count of ≤350 cells/mm3 to initiate ART were compared between 2010 Option A and the 2013 recommendations. Total costs of prevention of mother-to-child transmission of HIV (PMTCT) services per annual cohort of pregnant women, incremental cost-effectiveness ratio (ICER) per infection averted and quality-adjusted life-year (QALY) gained were examined. Results Our analysis suggested that the shift from 2010 Option A to the 2013 guidelines would result in a 33% reduction of the risk of HIV transmission among exposed infants. The risk of transmission to serodiscordant partners for a period of 24 months would be reduced by 72% with ‘ARVs during pregnancy and breastfeeding’ and further reduced by 15% with ‘Lifelong ART’. The probability of HIV-infected pregnant women to initiate ART would increase by 80%. It was also suggested that while the shift would generate higher PMTCT costs, it would be cost-saving in the long term as it spares future treatment costs by preventing infections in infants and partners. Conclusion The shift to the WHO 2013 guidelines in Zambia would positively impact health of family and save future costs related to care and treatment.

HIV service delivery models towards ‘Zero AIDS-related Deaths’: a collaborative case study of 6 Asia and Pacific countries

BackgroundIn the Asia-Pacific region, limited systematic assessment has been conducted on HIV service delivery models. Applying an analytical framework of the continuum of prevention and care, this study aimed to assess HIV service deliveries in six Asia and Pacific countries from the perspective of service availability, linking approaches and performance monitoring for maximizing HIV case detection and retention.MethodsEach country formed a review team that provided published and unpublished information from the national HIV program. Four types of continuum were examined: (i) service linkages between key population outreach and HIV diagnosis (vertical-community continuum); (ii) chronic care provision across HIV diagnosis and treatment (chronological continuum); (iii) linkages between HIV and other health services (horizontal continuum); and (iv) comprehensive care sites coordinating care provision (hub and heart of continuum).ResultsRegarding the vertical-community continuum, all districts had voluntary counselling and testing (VCT) in all countries except for Myanmar and Vietnam. In these two countries, limited VCT availability was a constraint for referring key populations reached. All countries monitored HIV testing coverage among key populations.Concerning the chronological continuum, the proportion of districts/townships having antiretroviral treatment (ART) was less than 70% except in Thailand, posing a barrier for accessing pre-ART/ART care. Mechanisms for providing chronic care and monitoring retention were less developed for VCT/pre-ART process compared to ART process in all countries.On the horizontal continuum, the availability of HIV testing for tuberculosis patients and pregnant women was limited and there were sub-optimal linkages between tuberculosis, antenatal care and HIV services except for Cambodia and Thailand. These two countries indicated higher HIV testing coverage than other countries.Regarding hub and heart of continuum, all countries had comprehensive care sites with different degrees of community involvement.ConclusionsThe analytical framework was useful to identify similarities and considerable variations in service availability and linking approaches across the countries. The study findings would help each country critically adapt and adopt global recommendations on HIV service decentralization, linkages and integration. Especially, the findings would inform cross-fertilization among the countries and national HIV program reviews to determine county-specific measures for maximizing HIV case detection and retention.

Towards a fair consideration of PrEP as part of combination HIV prevention in Latin America

Despite progress in scaling up antiretroviral treatment, HIV prevention strategies have not been successful in significantly curbing HIV incidence in Latin America. HIV prevention interventions need to be expanded to target the most affected key populations with a combination approach, including new high impact technologies. Oral pre‐exposure prophylaxis (PrEP) is recommended as additional prevention choice for individuals at higher risk of infection and could become a cost‐effective prevention tool. We discuss the barriers and solutions for a fair consideration of PrEP as part of combination HIV prevention strategies in Latin America.

Use of third line antiretroviral therapy in Latin America

Background Access to highly active antiretroviral therapy (HAART) is expanding in Latin America. Many patients require second and third line therapy due to toxicity, tolerability, failure, or a combination of factors. The need for third line HAART, essential for program planning, is not known. Methods Antiretroviral-naïve patients ≥18 years who started first HAART after January 1, 2000 in Caribbean, Central and South America Network (CCASAnet) sites in Argentina, Brazil, Honduras, Mexico, and Peru were included. Clinical trials participants were excluded. Third line HAART was defined as use of darunavir, tipranavir, etravirine, enfuvirtide, maraviroc or raltegravir. Need for third line HAART was defined as virologic failure while on second line HAART. Results Of 5853 HAART initiators followed for a median of 3.5 years, 310 (5.3%) failed a second line regimen and 44 (0.8%) received a third line regimen. Cumulative incidence of failing a 2nd or starting a 3rd line regimen was 2.7% and 6.0% three and five years after HAART initiation, respectively. Predictors at HAART initiation for failing a second or starting a third line included female sex (hazard ratio [HR] = 1.54, 95% confidence interval [CI] 1.18–2.00, p = 0.001), younger age (HR = 2.76 for 20 vs. 40 years, 95% CI 1.86–4.10, p<0.001), and prior AIDS (HR = 2.17, 95% CI 1.62–2.90, p<0.001). Conclusions Third line regimens may be needed for at least 6% of patients in Latin America within 5 years of starting HAART, a substantial proportion given the large numbers of patients on HAART in the region. Improved accessibility to third line regimens is warranted.

Implementing Early-Warning Indicators of HIV Drug Resistance in the Caribbean

A key component of the World Health Organizations (WHOs) Global HIV Drug Resistance (HIVDR) prevention and assessment strategy is to monitor HIVDR early-warning indicators (EWIs), which provide strategic information for HIVDR containment. The Pan American Health Organization (PAHO)/WHO supported implementation of HIVDR EWI monitoring in 16 Caribbean countries. Results from 15 countries were analyzed by year of patient initiation of antiretroviral therapy for the period 2005-2009. This report demonstrates the need for capacity-building to standardize prescribing practices and to strengthen adherence strategies and antiretroviral drug procurement management systems.

Elimination of mother-to-child transmission of HIV and Syphilis (EMTCT): Process, progress, and program integration

Melanie Taylor and colleagues discuss progress towards eliminating vertical transmission of HIV and syphilis.

Progress of implementation of the World Health Organization strategy for HIV drug resistance control in Latin America and the Caribbean

By the end of 2010, Latin America and the Caribbean (LAC) achieved 63% antiretroviral treatment (ART) coverage. Measures to control HIV drug resistance (HIVDR) at the country level are recommended to maximize the efficacy and sustainability of ART programs. Since 2006, the Pan American Health Organization has supported implementation of the World Health Organization (WHO) strategy for HIVDR prevention and assessment through regional capacity-building activities and direct technical cooperation in 30 LAC countries. By 2010, 85 sites in 19 countries reported early warning indicators, providing information about the extent of potential drivers of drug resistance at the ART site. In 2009, 41.9% of sites did not achieve the WHO target of 100% appropriate first-line prescriptions; 6.3% still experienced high rates (> 20%) of loss to follow-up, and 16.2% had low retention of patients (< 70%) on first-line prescriptions in the first year of treatment. Stock-outs of antiretroviral drugs occurred at 22.7% of sites. Haiti, Guyana, and the Mesoamerican region are planning and implementing WHO HIVDR monitoring surveys or threshold surveys. New HIVDR surveillance tools for concentrated epidemics would promote further scale-up. Extending the WHO HIVDR lab network in Latin America is key to strengthening regional lab capacity to support quality assured HIVDR surveillance. The WHO HIVDR control strategy is feasible and can be rolled out in LAC. Integrating HIVDR activities in national HIV care and treatment plans is key to ensuring the sustainability of this strategy.

The multi-step process of building TB/HIV collaboration in Cambodia.

Tuberculosis and HIV/AIDS have synergistic health impacts in terms of disease development and progression. Therefore, collaborative TB and HIV/AIDS activities are a logical health systems response. However, the establishment of these activities presents a challenge for countries that have strong vertical disease programs that differ in their implementation philosophies. Here, we review the process by which TB/HIV collaboration was established in Cambodia. A cycle of overlapping and mutually reinforcing initiatives – local research; piloted implementation with multiple options; and several rounds of policy formulation guided by a cross-functional Technical Working Group – was used to drive nationwide introduction of a full set of TB/HIV collaborative activities. Senior Ministry of Health officials and partner organizations brought early attention to TB/HIV. Both national programs implemented initial screening and testing interventions, even in the absence of a detailed, overarching framework. The use of multiple options for HIV testing identified which programmatic options worked best, and early implementation and pilots determined what unanswered questions required further research. Local conduct of this research – on co-treatment timing and TB symptom screening – speeded adoption of the results into policy guidance, and clarified the relative roles of the two programs. Roll-out is continuing, and results for a variety of key indicators, including screening PLHIV for TB, and testing TB patients for HIV, are at 70-80% and climbing. This experience in Cambodia illustrates the influence of health research on policy, and demonstrates that clear policy guidance, the pursuit of incremental advances, and the use of different approaches to generate evidence can overcome structural barriers to change and bring direct benefits to patients.

Cuba Validated as the First Country to Eliminate Mother-to-Child Transmission of Human Immunodeficiency Virus and Congenital Syphilis: Lessons Learned from the Implementation of the Global Validation Methodology.

TheWorld Health Organization (WHO) estimates that each year 150,000 [110,000–190,000] infants are born with human immunodeficiency virus (HIV) and 350,000 perinatal deaths are caused by untreated maternal syphilis at the global level. Results from HIV clinical trials demonstrated effectiveness of antiretroviral therapy for prevention of HIV transmission from mother to child. However, the goal of elimination of mother-to-child transmission (EMTCT) of HIV remained largely aspirational until the adoption of the HIV elimination target by the Americas region in 2010 and the launch of the Global Plan for EMTCT of HIV in 2011. An effective intervention against congenital syphilis—early serologic detection of infection in women before or during pregnancy, and treatment of syphilis-infected women with parenteral penicillin—has been available for 70 years. However, until recently, syphilis testing in antenatal care (ANC) remained limited in countries with constrained laboratory capacity. In 2007, WHO launched a strategy for the elimination of congenital syphilis as a public health problem. Congenital syphilis elimination had already been established as a priority in the Americas a decade before the launch of the global strategy. The Member States of the Pan American Health Organization (PAHO) formally adopted the dual EMTCT target in 2010. The Regional framework combined the target for EMTCT of HIV with the existing regional commitment for elimination of congenital syphilis; and defined dual elimination as (1) reduction of the rate of MTCTof HIV to 2% or less per year, along with reduction of the incidence of MTCT of HIV to 0.3 cases or less per 1000 live births, and (2) reduction of the incidence of congenital syphilis to 0.5 cases or less (including stillbirths) per 1000 live births. These targets were developed based on evidence regarding effectiveness of treatment and modeled predictions of the transmission levels that can be reached with optimal coverage of detection and treatment services. To monitor progress, PAHO developed a regional monitoring framework and prepared periodic progress reports.

Progress and challenges in implementing HIV care and treatment policies in Latin America following the treatment 2.0 initiative

BackgroundThe Pan American Health Organization provides technical cooperation to countries in Latin America and the Caribbean for the scale-up of HIV care and treatment based on the Treatment 2.0 initiative. Fourteen Joint Review Missions (JRMs) were conducted between March 2012 and October 2014. Evaluating the degree of implementation of the recommendations of the JRMs and their impact on health policies, would help countries identify their gaps and areas for priority interventions.MethodsA descriptive analysis of the JRM recommendations was conducted for eight countries. An in-depth cross-sectional retrospective analysis of the degree of implementation of these recommendations in Ecuador, Venezuela, Bolivia, and El Salvador was performed through a standardized self-administered questionnaire applied to key informants. A comparative quantitative analysis on the optimization of antiretroviral regimens ‘before/after’ JRMs was conducted in three of the latter four countries, using data reported in 2013 and 2014.ResultsThe priority areas with most recommendations were the optimization of antiretroviral treatment (ART) regimens (n = 57), the rational and efficient use of resources (n = 27) and the provision of point-of-care diagnostics and monitoring tools (n = 26), followed by community mobilization (n = 23), strategic information (n = 17) and the adaptation of delivery services (n = 15). The in-depth analysis in four countries showed that the two priority areas where most progress was observed were the rational and efficient use of resources (62 %) and the optimization of ART regimens (60 %). Adaptation of delivery services, community mobilization and strategic information were rated at 52 % and the provision of point-of-care diagnostics and monitoring tools 38 %. The quantitative analysis on optimization evidenced a 36 % reduction in the number of first-line and second-line ART regimens, a 5.4 % increase in the proportion of patients on WHO-recommended first-line regimens, a 19.4 % increase in the use of the WHO preferred first-line regimen, 51 % increase in the use of WHO-recommended second-line regimens, and a significant reduction in the use of obsolete drugs in first- and second-line regimens (respectively 1 and 9 % of regimens in 2013).ConclusionsA relatively good level of progress was perceived in the recommendations related to optimization of ART regimens. Challenges remain on the improvement of recommendations related to health system strengthening and the promotion and support aimed at community-based organizations as part of the response to HIV/AIDS in Latin America. The JRMs are a useful mechanism for providing coherent technical support to guide countries in the pursuit of a comprehensive response to HIV/AIDS in the Latin American region.