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Overcoming the barriers to timely antiretroviral initiation in HIV-infected infants.

Without antiretroviral therapy (ART), 50% of infants with perinatal human immunodeficiency virus (HIV) infection will die by 2 years of age [1]. Because early ART initiation in these infants can reduce mortality risk by 76% [2], early infant HIV diagnosis and treatment has become a global priority. Since 2008, the World Health Organization (WHO) has recommended that HIV-infected infants initiate ART regardless of clinical or immunologic status [3]. The United Nations General Assembly also included improving early infant diagnosis and ART initiation in their 2011 Political Declaration on HIV and AIDS [4]. However, although the number of HIV-infected children receiving ART increased 14% globally in 2012, ART coverage remains 50% lower in HIV-infected children than in adults (34% vs. 64%) [5]. Why does ART coverage for HIV-infected infants remain low despite evidence that ART is essential for infant survival? The challenge of early infant HIV diagnosis contributes to the slower uptake of ART in children compared with adults [5]. The WHO recommends that HIV virologic testing be performed in all HIVexposed infants at 6 weeks of life; however, this occurs in less than 15% of infants [3]. The persistence of maternal anti-HIV antibodies requires that HIV virologic testing be used in infants, typically through nucleic acid-based testing like PCR, instead of the faster and less expensive serologic tests used to diagnose HIV in adults and older children. In resourceunconstrained settings, HIV virologic testing requires significant infrastructure. This begins with skilled staff, from phlebotomists who obtain blood samples to laboratory technicians who perform testing, machine maintenance and daily quality assurance. Nucleic acid-based methods require stable handling environments, specialized equipment and reagents. Resource-constrained settings may not have many of these prerequisites. Also laboratory facilities are often centralized, presenting problems with specimen transportation and delays in results reporting [6, 7]. New diagnostic techniques have been devised to compensate for difficulties in early infant HIV diagnosis in resource-constrained settings. One of the most widely used is dried blood spot testing, which eliminates the need for sample refrigeration, greatly simplifying specimen collection and transport [8]. Dried blood spot testing has been found to be a sensitive means of HIV-1 viral load quantitation, particularly when larger portions of the dried blood spot are used in the PCR reaction [9, 10]. In settings where there is limited access to reliable facilities and other expertise, fully automated devices that utilize closed cartridges make virologic testing more feasible [11, 12]. To conserve resources, some authors suggest a tiered laboratory approach where rural (or primary) labs perform initial testing with specialized testing being referred to centralized labs [7]. Where this system is implemented, specimen pooling can decrease the cost per sample [13]. Although technology to allow early infant HIV diagnosis exists, attrition along the HIV treatment cascade (HIV diagnosis, entry to care, ART initiation and long-term follow-up) continues to be a global problem. A study in Malawi investigating the success of an early infant diagnosis program demonstrated that socio-cultural factors beyond access to HIV virologic tests and ART for infants contribute [8]. The program provided education to HIV-infected pregnant women and the community about the importance of infant virologic testing, free virologic testing for the infants at 6 weeks, active tracing of the infants who tested positive whose parents did not return for the results and referral for ART and HIV care for the HIV-infected infants. Even with this support, only 26% of HIV-infected infants initiated ART. Infants were lost at every stage in the cascade: 28% of HIV-infected pregnant women did not attend the prenatal clinics, 28% who attended prenatal clinics did not access free virologic testing at 6 weeks, 13% of parents of infants who tested positive for HIV did not return for the results and also could not be traced by community health staff, and 42% of the HIV-infected infants, whose parents were informed of their status and referred for treatment, did not initiate ART. These socio-cultural factors are not unique to resource-constrained settings. In the United States, HIV care has been provided free of charge for years through federal programs to HIV-infected individuals under a certain income level. This HIV care includes ART, laboratory testing, medical clinic visits, psychiatric care and case management. However, a recent study estimated that only 36% of the 1.1 million HIV-infected individuals in the United States are on ART, despite recommendations in the United States for ART initiation at any CD4 T cell count [14]. Even in resource unconstrained settings, individuals are lost at every stage in the treatment cascade: 20% are not diagnosed, 23% of those diagnosed are not linked to care and 41% of those linked to care are not on ART. As clinicians at two of these federally funded HIV clinics, we experience first-hand the challenges in linking HIV-infected adults to care. These challenges are JOURNAL OF TROPICAL PEDIATRICS, VOL. 60, NO. 4, 2014