for this are multiple, and most are currently being addressed by PEPFAR (OGAC, 2005b, 2006d). All elements of treatment have been more difficult in young children than adults. Diagnosis of HIV/AIDS in children has been limited in part because most counseling and testing programs in the focus countries have targeted primarily young adults. The general lack of linkage of prevention of mother-to-child transmission to testing of infants and small children has lessened the likelihood of identifying those who are HIV-positive at that level. Many children who are found to be HIV-positive are orphans or living with orphan heads of households, further complicating adherence to treatment regimens and follow-up clinical visits (GAA, 2006). Treatment has frequently been compromised by initial extreme shortages or absence of U.S. Food and Drug Administration (FDA)-approved generic pediatric formulations of ARVs, especially oral suspensions, which are most helpful for infants and small children, and by the fact that one of the initially utilized pediatric formulations required refrigeration (WHO, 2006a). There still are no available FDA-approved combination preparations in dosages appropriate for small children and infants. This problem is exacerbated by the fact that several focus countries have few if any pediatricians, and general practitioners are often reluctant to assume responsibility for treatment of small children with HIV/AIDS. Even experienced clinicians with whom the Committee visited reported some hesitation in initiating treatment of children because of the complexity of dosing and the need to vary doses over time as the child grows.

A further complicating factor is the very high rate of HIV/tuberculosis coinfection in small children. Such coinfection has been even more common in small children than in adults in the few regions for which relevant data are available (GAA, 2006; UNAIDS, 2006). This has added to the complexity of already difficult dosing schedules. (Tuberculosis/HIV coinfection is discussed further below.)

Despite the many ongoing obstacles to treatment for children, PEPFAR has supported the initiation of pediatric ART programs in all focus countries (OGAC, 2006a,c,d,f,g).

Need for Continued Attention to Marginalized Populations

There is little data available with which to determine how successful PEPFAR-supported ART programs have been in providing access to treatment by especially vulnerable populations in whom HIV prevalence usually exceeds that of the general population. These populations include, but are not limited to, incarcerated people, people who engage in commercial sex work, men who have sex with men, and people who use injection drugs. PEPFAR reported that it is supporting a variety of ART programs that focus on these populations. However, there is a need to further develop and

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