What is HIV and AIDS?
Human immunodeficiency virus-1 (HIV) is a virus that attacks the immune system by destroying CD4+ T cells, a type of white blood cell that fights infections. If HIV is left untreated, HIV can progress to Acquired Immunodeficiency Syndrome (AIDS). AIDS is the late stage of HIV infection that occurs when the body’s immune system is severely damaged, which can lead to life-threatening infections. HIV is commonly transmitted by having sex or sharing needles with someone who has the virus. Specifically, HIV is spread through certain body fluids (blood, semen, pre-seminal fluids, rectal fluids, vaginal fluids, and breast milk).
The human body cannot get rid of the virus and no effective cure exists. However, with proper medical care, HIV can be controlled with HIV medicines.
HIV medicines, also referred to as drugs, prevent HIV from multiplying in the human body and reduce the amount of the virus in the body. The immune system can recover because there is less virus in the body. Although HIV remains in the body, the immune system is strong enough to fight off other infections. By reducing the amount of HIV in the body, HIV medicines also reduce the risk of HIV transmission to sexual partners. Treatment with HIV medicines is called antiretroviral therapy (ART). ART involves taking a combination of HIV medicines lifelong. Please see adults, pregnant women, and pediatrics links for dosing recommendations. ART cannot cure HIV but helps people live longer and healthier lives.
CDER’S Role in HIV Prevention and Treatment
As part of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation and Research’s (CDER’s) role in HIV prevention and treatment is to regulate prescription drugs, including biological therapeutics. CDER evaluates the benefits and risks of drugs for HIV prevention and treatment by making sure that safe and effective drugs are available to improve the health of patients. The center is committed to protect and promote public health by making certain drugs for HIV prevention and treatment are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients.
Notably, among the regulatory activities, CDER:
- Works with pharmaceutical sponsors (developers) and researchers of new drugs to assure that clinical trials are safe, well designed, scientifically sound, ethically conducted, and appropriately analyzed.
- Reviews the data collected from clinical trials to establish evidence of safety and effectiveness.
- Approves applications for new drugs that meet the FDA standards for safety and effectiveness, which allows for marketing of the drug in the U.S.
- Collects and evaluates safety information associated with marketed drugs.
- Disseminates timely drug information to the medical community and the general public when safety issues arise related to approved treatments.
- Works with pharmaceutical sponsors, prescribers, and patients to provide information and a regulatory framework within which to allow access to promising investigational (unapproved) drugs when no practical, approved alternatives are available. Tens of thousands of patients have accessed promising, unapproved treatments through expanded access programs.
Improving Access to HIV/AIDS Drugs Abroad
To support the President's Emergency Program for AIDS Relief (PEPFAR, PEPFAR/FDA), FDA developed a review process that allows CDER to quickly review applications for single entity, fixed-dose combination, and co-packaged versions of previously approved HIV drugs, even if patent or exclusivity market protection exists for the drug(s). This process makes HIV drugs available in developing countries, while protecting the property rights of pharmaceutical companies in the U.S.
CDER reviews the applications for PEPFAR drugs using the same standards it used for other drug approvals. If the product still has marketing protection in the U.S., CDER issues a "tentative” approval rather than a "full" approval. The "tentative" approval signifies that the product meets all safety, efficacy, and manufacturing quality standards for marketing in the U.S., and, but for the legal market protection, it would be on the U.S. market. Products that have either a "full" or "tentative" FDA approval may be purchased for use under the PEPFAR program. In this manner, the products being offered under this program to developing countries are products that we would offer our own citizens.