The U.S. President's Emergency Plan for AIDS Relief (PEPFAR)

• What Is PEPFAR?
• Drug Approval
• 5-Year Goals, Progress and Budgets
• The Bottom Line

What Is PEPFAR?

In 2003, the U.S. congress passed a bill to provide money to foreign governments to fight HIV/AIDS, tuberculosis and malaria. This plan is the President's Emergency Plan for AIDS Relief (PEPFAR.) It is the largest commitment by any nation to combat a single disease in history. The total funds under PEPFAR total over $50 billion. PEPFAR funds are helping more than 30 countries in Africa, Asia, the Caribbean, and Eastern Europe. More information on participating countries can be found at www.pepfar.gov/countries/index.htm.

The program goals through 2013 include TREATMENT, PREVENTION and CARE. In addition, PEPFAR is building health systems to continue their work under PEPFAR and be accountable for results.

TREATMENT includes commitment by government and community leaders; national HIV/AIDS policy and clinical guidelines; training programs for clinical and laboratory staff; laboratory supplies and staffing support; and community outreach to promote adherence to antiviral treatment.

PREVENTION activities are based on the specific HIV epidemic in each country. These include reducing sexual transmission with the ABC Strategy (Abstain, Be Faithful, use Condoms), the prevention of infections from mothers to children, preventing infections due to unsafe blood and medical injections, and male circumcision, and HIV counseling and testing.

CARE includes care for orphans and vulnerable children, and care and support for people infected with or affected by HIV/AIDS. PEPFAR focuses on strengthening the capacity of families to protect and care for orphans and vulnerable children by extending the lives of parents and caregivers. PEPFAR also provides prevention and treatment of AIDS-related infections and cancers, pain and symptom management, psychological, social, spiritual, and preventive services.

Testing positive can link people to prevention, treatment, and care. PEPFAR targets counseling and testing to people at high risk of HIV infection. This includes tuberculosis patients and women who might transmit HIV to their children.

Drug Approval

To support PEPFAR, the US Food and Drug Administration (FDA) developed a way to ensure that medications are safe and effective. Products "tentatively approved" under PEPFAR cannot be sold in the US if that would conflict with the patent protections of the original manufacturer.

The FDA encouraged manufacturers to apply for approval of single drugs, combinations of various products in a single pill and versions of approved drugs packaged in convenient combinations. Products are reviewed using normal standards.

PEPFAR can purchase any product with full or tentative approval. The FDA helps manufacturers prepare for FDA approvals and inspections of their clinical trials and manufacturing facilities. Reviews are done quickly; in some cases, within 2 to 6 weeks.

The FDA is also working with foreign drug approval agencies to help them understand the FDA approval process. This encourages local country approvals of PEPFAR drugs. A full list of approved products is on the Internet at www.fda.gov/oia/pepfar.htm

5-Year Goals, Progress and Budgets

On December 1, 2009, PEPFAR launched a 5-year strategy. For more information, please see http://www.pepfar.gov/strategy

Treatment

Goal: Support treatment for 2 million HIV-infected individuals.
Progress: Through September 2008, PEPFAR has supported treatment for more than 2.1 million men, women and children. Through October 2012, a total of 154 antiviral products have been approved through August 2009 for use by PEPFAR. A full list of approved products is on the Internet at www.fda.gov/oia/pepfar.htm
Budget: In 2008, PEPFAR provided $1.6 billion in support of treatment programs, or approximately 48.4% of funding in the program's focus countries.

Prevention

Goal: Support the prevention of 7 million infections.
Progress: Through September 30, 2008, PEPFAR reached about 58.3 million people through community outreach programs to prevent sexual transmission using the "ABC" approach (abstinence, be faithful, use condoms.) Also, the U.S. Government provided more than 2.2 billion condoms worldwide from 2004 to 2008. PEPFAR also helped prevent transmission of HIV from pregnant women to their children by providing medications to over 17 million pregnant women.
Budget: PEPFAR provided approximately $712 million to support prevention activities. This is 22% of program funding. If counseling and testing are counted as prevention, this increases to 29 percent.

Care

Goal: To support care for 10 million people infected and affected by HIV/AIDS, including orphans and children.
Progress: Through September 2008, PEPFAR supported care for more than 10.1 million people, including over 4 million children. HIV counseling and testing was provided for nearly 57 million people. Tuberculosis treatment was provided to more than 395,400 HIV-infected people.
Budget: In fiscal year 2008, PEPFAR provided $953 million, or 29.5% of focus country resources for care activities.

Sustainability and Accountability

Goal: No specific goal has been set.
Progress: Through September 2008, PEPFAR partnered with over 2,500 local and national organizations. Local organizations were 86% of this total. About 3.7 million health care worker training encounters were supported.
Budget: Through fiscal year 2008, PEPFAR provided over $1.3 billion to support training and organizational capacity building.

The Bottom Line

PEPFAR is the largest commitment in history by any nation to fight a disease. Over $50 billion has been committed to PEPFAR.

In addition to treatment, prevention, and care, PEPFAR will help create health care organizations that will continue in the future, and that will be accountable for the resources they receive.

More information on the US President's Plan for AIDS Relief is available at the web site www.pepfar.gov/.