Treatment has been the major success of PEPFAR. Prior to its creation in 2003, only about 50,000 individuals were on treatment in all sub-Saharan Africa. Six years later, PEPFAR is supporting more than 2.4 million people on treatment worldwide. By combining the delivery of lifesaving drugs with strong adherence support, PEPFAR's drug compliance and efficacy rates are equivalent to those in the United States. A May 2009 study published in the Annals of Internal Medicine found that HIV-related mortality rates had dropped by 10.5% in the PEPFAR countries analyzed by researchers - implying that about 1.2 million deaths were averted due to PEPFAR.⁸. Despite overwhelming odds, PEPFAR's first five years amply demonstrated that complicated treatment regimens can be delivered in a range of low-resource settings. The challenge of the next phase is to build the conditions through which to create eventual sustainability in PEPFAR's treatment programs.

Further increasing the global challenges in meeting treatment needs are data suggesting greater clinical benefits for individuals starting therapy earlier in the course of their infection. The WHO recently released a recommendation to initiate treatment at a CD4 cell count of 350/mm³, rather than 200/mm³. PEPFAR will continue to scale up its treatment programming in a manner that emphasizes health systems strengthening and creation of country-level capacity.

The benefits of treatment remain abundantly clear; people on treatment have improved immune function, resulting in fewer opportunistic diseases such as TB. People on treatment also have lower viral loads, which dramatically reduces transmissibility of the virus. There has been a significant decrease in hospital admissions due to wider availability of ARVs. Treatment extends lives, keeps families together, allows workers to continue and return to jobs, and reduces the number of OVCs. Research is also under way to determine the prevention impacts of treatment upon communities and populations. Finally, PEPFAR's programs have significant diplomatic benefits, increasing goodwill among the communities who have seen the impact of treatment.

Over its next phase, PEPFAR is configuring its treatment programs to achieve the following goals:

Targeting treatment

PEPFAR will continue to achieve major health impacts by expanding access to treatment, with a particular emphasis on the following:

Reaching the sickest first

Millions of people with CD4 cell counts under 200/mm³ are not currently reached by treatment. Within the context of national priorities, PEPFAR is making it a priority to reach the sickest individuals first, in order to prevent as many immediate deaths as possible. In countries with high coverage rates that are expanding eligibility, PEPFAR is helping to provide technical assistance and support for the overall treatment infrastructure. Given that many individuals are only tested once they become symptomatic, PEPFAR is also expanding country efforts to better link testing and counseling with treatment and care.

Pregnant women

In its next phase, PEPFAR will continue to intensify its focus on PMTCT as part of its prevention portfolio. In conjunction with that effort, PEPFAR supports countries in plans to expand treatment to pregnant women. Such a move not only prevents perinatal transmission, but also better sustains the health of the mother, resulting in additional positive impacts on her family's health and well-being.

PEPFAR is working to link and integrate broader antenatal care services with counseling, testing and treatment for pregnant women. Over its next phase, PEPFAR will work with countries to achieve 85% ARV prophylaxis or treatment of eligible pregnant women found to be HIV-infected. By targeting pregnant women, PEPFAR can also increase identification of and service provision to children HIV-positive mothers.

HIV/TB coinfected populations

TB is the leading cause of death for HIV-infected individuals, but identifying, treating, and preventing TB can dramatically reduce morbidity and mortality among those with HIV. PEPFAR is aggressively expanding its TB screening and HIV testing efforts to identify and treat coinfected individuals. PEPFAR is also working with countries to implement interventions to reduce the development of active TB and transmission of TB disease among those most at risk.

Supporting country-level coordination

In order to achieve the long-term goal of country-level sustainability, PEPFAR is increasing support to build country-level capacity to carry out national testing strategies. UNAIDS has been working with country partners to help define country-level need and develop estimates. It is now important to enable country-driven efforts to identify and to marshal multiple sources of funding to meet these treatment needs. PEPFAR is supporting technical assistance to countries as they work toward strategic adoption of new treatment guidelines, based on available programmatic capacity and country priorities. Over its next phase, PEPFAR will support country-level efforts to coordinate and integrate multiple sources of bilateral and multilateral treatment support. Doing so breaks down duplication and determines ways to jointly address the global need.

Increasing impact of pretreatment care and ensuring quality antiretroviral therapy programs

As part of efforts to work with countries to identify and implement effective and efficient practices, PEPFAR is assisting countries to aggressively prevent, identify, and treat opportunistic infections prior to the start of ARV treatment. With this activity, PLWHAs remain healthier longer, thus delaying the need for treatment. Once PEPFAR initiates treatment, programs work to maximize drug adherence and retention in care. Effective measures for doing so include use of pharmacy records and targeted monitoring, with a focus on gaining the greatest utility from first-line medications.

PEPFAR is working to detect acquired drug resistance and develop strategies to respond to this resistance. These efforts of PEPFAR will be closely linked to the efforts of other partners such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund), UNAIDS, and the Gates Foundation to improve programmatic quality and better achieve "value for money." In its next phase, PEPFAR will also increase engagement of multilateral organizations, regional actors, private foundations and companies, and partner governments, among others, to address legal and regulatory barriers to the availability of high quality, inexpensive HIV-related commodities from local or international sources.

Expanding integration of treatment with both PEPFAR and other health programs

Treatment programs are not just clinical interventions, but opportunities to incorporate a holistic range of the health services needed to improve outcomes and quality of life for PLWHA. PEPFAR supports countries in efforts to coordinate and leverage treatment with prevention, care, and other health programs, as appropriate. In the next phase, PEPFAR treatment programs can serve as a platform to link to health services, including:

Integration with PEPFAR prevention and care services

PEPFAR treatment programs are often already integrated with pre-antiretroviral treatment (ART) services for PLWHA. Many PEPFAR treatment programs are used as a point to engage in Health, Dignity, and Prevention Programs for PLWHA, their partners, and their families. PEPFAR is working with countries to integrate treatment with standard packages of pre-ART, essential support services, and necessary prevention services for PLWHAs and their families.

Integration with other health and development programs

In many of the countries where PEPFAR works, clients and their families also suffer from malnutrition, TB, malaria, and other chronic progressive conditions requiring medical attention. HIV-positive women need routine reproductive health services. Their children need preventive care, like immunizations, and diagnosis and treatment of illnesses, like diarrhea and pneumonia. PEPFAR treatment programs will be used as a platform from which to build linkages to multiple primary and specialty health services. Doing so increases community-level access to quality care and reduces the stigma associated with HIV. Care and treatment will serve as one component of a clinic's broader service capacity, and clinics can be used as the base for referrals to community-based supportive services for PLWHA and their families.

Addressing the needs of vulnerable populations

There are specific populations that require additional considerations when transitioning them into treatment, including the following:

Pediatric populations

It is estimated that by two years of age, over 50% of children infected with HIV will have died in the absence of treatment.⁹ New pediatric HIV infections have become exceedingly rare in the U.S. due to the rapid expansion of effective ARV prophylaxis and treatment to HIV-infected pregnant women. PEPFAR supports making such infections equally rare in the developing world. However, the millions of children already living with HIV or newly infected with HIV need a range of services to stay alive and thrive.

PEPFAR is working to support treatment for pediatric populations at a level commensurate with their representation in a larger country epidemic. For example, based on prevalence surveys, if children represent 10% of the PLWHA population in a given country, PEPFAR should also strive to ensure that they represent 10% of those on ARV treatment in that country.

In order to provide treatment to infants, PEPFAR and other funders must continue to scale up early infant diagnosis and laboratory referral networks that produce rapid results for use by clinicians. PEPFAR is focusing on reaching a target of 65% early infant diagnosis, enabling newly diagnosed infants to receive care and treatment. PEPFAR is also working with countries to ensure that 80% of older children of HIV-positive mothers are tested and referred to care and treatment as necessary.

Marginalized populations

The stigma, discrimination, and marginalization faced by most-at-risk populations often extends into the health care system. In its next phase, PEPFAR will renew efforts to ensure its supported treatment programs are responsive to the needs of marginalized populations. PEPFAR is working with countries to expand linkages between prevention, treatment and care programs that address the needs of these populations. Examples include opioid substitution therapy as necessary for HIV-positive IDUs, or post-exposure prophylaxis for those who have experienced sexual assault. PEPFAR will also supporting efforts to ensure that health care workers are trained to protect patient confidentiality and provide nonjudgmental services. Finally, given that these groups are often ones that do not receive attention at a national level, PEPFAR is working with governments to incorporate their needs into national treatment plans.

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