Commentary: Pediatric HIV Treatment: Nurturing Access Through Health Facility Availability and Stock-out Monitoring

In 2023, an estimated 1.4 million children (0–14 years) were living with HIV, with over 80% of them living in sub-Saharan Africa.1 Encouragingly, this number is gradually declining, partly due to significant improvements in the quality, safety and number of child-friendly antiretroviral treatment (ART) options in recent years.1 Despite this, HIV treatment outcomes in children still substantially lag those of adults.1 Continuous use of ART is essential for saving lives. Poor availability and stock-outs of ART at health facilities negatively impact HIV care by causing delays in treatment initiation, incomplete treatments, treatment interruptions, and disengagement from care, resulting in higher risks of nonadherence, drug resistance and treatment failure.2 Continuous availability of pediatric ART formulations is particularly challenging due to the potential need for cold storage, short shelf lives and lower demand for these formulations compared with adult formulations.3 It is important to note that significant progress has been made over the years in simplifying pediatric ART regimens.3 This has led to more efficient supply chains with shorter master lists for pediatric ART formulations. Furthermore, the introduction of dispersible fixed-dose combination tablets for children has reduced the reliance on formulations with short shelf lives or requiring refrigeration. Despite these advances, concerns about the availability of pediatric ART persist as mothers living with HIV reported that stock-outs hinder HIV treatment and prophylaxis for their children.4 Addressing challenges in access to medicine for children living with HIV is critical to achieving the goal of ending AIDS as a public health threat by 2030, in alignment with Sustainable Development Goal (SDG) 3.3.5 Ensuring access to safe, effective and quality-assured medicines for all has been included in the SDG targets, specifically targets 3.8 and 3.b.6 To track the progress of these SDG targets, monitoring access to essential medicines at primary health facilities has been included as an SDG indicator integrating availability and affordability as the 2 key components. While much data about national pediatric ART procurement programs may be available, very limited data about local availability is accessible in the public domain. The WHO-Health Action International (HAI) cross-sectional methodology is the gold standard for measuring prices, availability, and affordability of medicines at health facilities globally,7 and is often used to measure progress toward the SDG targets. It is designed to systematically sample a diverse range of health facility levels within a region, including the regional referral center, and allows for both intra- and intercountry comparison of drug availability.8 Incorporating questions related to stock-outs into the questionnaire provides longitudinal insights into drug availability at the facilities.9 Of note, for ART, the individual drug affordability component is less relevant as ART is generally provided free of charge to children living with HIV in high-burden countries. The selection of pediatric ART formulations that should be available at local health facilities is guided by national pediatric HIV treatment guidelines and the WHO Optimal Formulary.3 The formulary includes preferred drug formulations that should be readily available for children living with HIV globally, as well as limited-use products needed for short periods or in low volumes.3 The list is based on current WHO recommendations, user-friendliness, dosing flexibility, supply chain optimization, and comparative costs. A complicating factor in defining the list of essential formulations is the uncertainty around future needs for pediatric ART. This is particularly relevant given recent reports of dolutegravir resistance among Malawian children.10 The emerging resistance to first-line pediatric ART regimens stresses the need for alternative ART, which are sometimes categorized as limited-use formulations. Alignment of country selection lists, either essential medicines list or national insurance formularies, to these global recommendations, should be investigated. Our recent study using WHO-HAI methodology showed that the availability of pediatric ART formulations was not yet optimal in 2 countries with extensive access programs.9 Preferred ART formulations had availabilities of 52.2% and 63.5% in Kenya and Uganda, respectively.9 To ensure continuous accessibility of medical care, WHO targets an 80% availability of affordable essential medicines for noncommunicable diseases in registered health facilities.7 This target was not met in our study. In our opinion, this benchmark should also apply for preferred pediatric ART formulations, as children living with HIV need chronic treatment and continuous drug availability, similar to noncommunicable diseases. However, this benchmark may not be realistic for limited-use formulations with low demand as it is not feasible for dispensaries to stock these medications. Still, we argue that at least regional referral hospitals should ensure the availability of these formulations for children who do not respond to, or tolerate, first-line ART. Our study identified some additional key issues in pediatric ART availability: overall availability of limited-use formulations was extremely low (1.1% in Kenya and 1.9% in Uganda); (2) availability of dolutegravir and abacavir/lamivudine (37.5% and 62.5%, respectively) was low in Kenyan private-not-for-profit facilities and (3) a significant number of Ugandan facilities reported at least one stock-out of nevirapine solution (43.1%), with no alternative formulations available for postnatal HIV prophylaxis.9 These findings from countries with strong access programs suggest that availability and stock-out monitoring are essential in guiding the implementation of focused approaches to improve the availability of pediatric ART formulations and thereby increase ART coverage among children in other high-burden countries. Furthermore, a recent observational study in several West African countries revealed that children under the age of 5 years, who require child-friendly ART formulations, currently face incomplete and inequitable access to dolutegravir.11 This study shows that suboptimal availability of DTG-based first-line appears to be a common issue across sub-Saharan African countries and underscores the need for wider assessment of pediatric ART availability at the health facility level in other high-burden countries. Conducting availability studies using the HAI-WHO methodology in other countries will help identify selection and supply issues and compare results across countries. To facilitate future studies on pediatric ART availability and stock-outs in high-burden countries, standardized monitoring tools should be implemented and supported by local ministries of health. These tools, such as implementing an electronic stock management system, allow for easy longitudinal data collection to track progress toward SDG 3.8 and 3.b targets and provide end-to-end visibility to ensure the quality of pediatric ART. South Africa recently implemented such an electronic stock management system in the public sector, supported by the National Surveillance Center, which is believed to be effective for monitoring and improving medicine availability.12 Furthermore, existing processes can be optimized by incorporating pediatric ART stock management questions. In Kenya, for example, such questions could be integrated into the Facility Consumption and Data Report and Request system.13 The next step would be to develop real-time data dashboards integrated with AI to optimize drug procurement and distribution by forecasting demand and predicting stock-outs. In addition to the quantitative data, qualitative studies are needed to understand barriers experienced by key stakeholders, including patients, healthcare workers, government staff and wholesalers. Qualitative research would allow for the identification of specific supply chain challenges causing availability issues as well as investigating the actual impact of stock-outs on children who experience interruptions in their ART. In summary, we advocate for countries to prioritize the monitoring of the availability and stock-outs of pediatric ART formulations at health facilities as an essential component of the effort to end AIDS as a public health threat by 2030. This will inform capacity-building interventions and drive improvement of national policies to increase access to high-quality treatment for children living with HIV. If we change the beginning of the story, we change the whole story.