By: Debra Birnkrant, M.D., Director, Division of Antivirals (DAV), Office of Infectious Diseases (OID), Center for Drug Evaluation and Research (CDER), and Jeffrey Murray, M.D., M.P.H, Deputy Director, DAV, OID, CDER
Each year, since 1998, countless organizations and individuals around the world have observed World AIDS Day – to bring attention to the HIV epidemic, increase HIV awareness and knowledge, speak out against HIV stigma, and work towards Ending the HIV Epidemic: A Plan for America.
Today, the U.S. Food and Drug Administration again observes this important day. It is a sobering reminder of the many people across the globe who have struggled and lost their battle to HIV/AIDS. Yet, more optimistically, this year’s theme “Ending the HIV/AIDS Epidemic: Resilience and Impact” allows us to reflect on the many advances in medicine that now help millions of people worldwide to live and thrive, despite being infected with HIV. There is still no cure, but progress over the years has been very encouraging, including approvals in 2020 for two new HIV therapeutic drugs.
When the AIDS epidemic emerged in the mid-1980s, there was not a single drug approved by the FDA to treat infected patients. In 1987, the FDA approved the first HIV therapy, zidovudine, in 107 days – at the time, the fastest FDA drug approval in history – and to this day, still among the fastest to be reviewed and approved for patients in need. Given the urgent need for therapy, we approved the drug based on evidence from only one clinical trial in humans and that trial was stopped after 19 weeks because patients taking the placebo were overwhelmingly dying faster than those given the drug and continuing the trial would have been unethical. Many of today’s regulatory tools used by the FDA for expediting review of critical drugs stem from the approvals of early HIV therapies.
Today, there are more than 30 FDA-approved drugs to treat and/or prevent infection with the HIV virus. These medical breakthroughs have transformed this disease into a treatable chronic condition. Thanks to these therapeutic advancements, after a year of treatment a 20-year-old patient diagnosed with AIDS has a life expectancy of 78 – nearly the same as the general population!
There have been countless important steps to help get us where we are today. Below highlights several:
- In 1987, the AIDS quilt was assembled for the first time on the national mall in Washington, D.C. Soon after, AIDS activists organized thousands of supporters for AIDS Walks in cities around the nation. These actions, along with many other acts of activism, encouraged the FDA to involve patients in the policy making process; we established the Office of AIDS and Special Health Issues to help build relationships with patient communities. We also created an initiative to include at least one patient representative on every advisory committee tasked with assessing new HIV therapies.
- In 1988, with a persistent need for additional safe and effective HIV therapies, the FDA created a new Division of Antiviral Products (DAVP), with the principal responsibility of reviewing applications for all drugs to treat HIV/AIDS. This change enabled the FDA to handle the growing number of new drug applications for HIV/AIDS and signified the agency’s commitment to expedite access and spur innovation.
- 2003 ushered in the President’s Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion commitment involving several federal agencies, host country governments, and other participants. As part of PEPFAR, the FDA implemented an expedited process to review and grant full or tentative approval of applications for new versions of existing HIV/AIDS drugs for distribution only in resource-limited nations. The program continues to this day, and the FDA has now granted more than 200 approvals or tentative approvals of HIV/AIDS drugs as part of PEPFAR.
- The FDA’s approval of the drug, Atripla, in July of 2006, marked a watershed in HIV treatment. Prior to that, HIV patients were typically prescribed three different antiviral medications administered as separate pills. Atripla combined these drugs – efavirenz, emtricitabine and tenofovir – into a single fixed combination pill. Instead of an assortment of multiple medications, HIV treatment could now be simplified into a once-daily single tablet regimen.
- In 2012, we approved Truvada (emtricitabine and tenofovir disoproxil fumarate), already approved since 2004 to treat HIV, as the first FDA-approved therapy to help prevent sexually transmitted HIV infection, another watershed approval.
- Recent years mark continued progress. In 2018, we approved the first monoclonal antibody treatment for HIV – Trogarzo (ibalizumab-uiyk), which offers a treatment option to the small percentage of HIV positive patients that are multidrug resistant, providing significant benefit to patients who have run out of HIV treatment options. In 2019, we approved Dovato (dolutegravir and lamivudine), the first FDA-approved two-drug, fixed combination, complete regimen for HIV-infected adults who have never received treatment for HIV. Previously, the standard of care for patients who have never been treated was a three-drug regimen, so this important new “drug sparing” regimen eliminates additional toxicity and potential drug interactions from a third drug.
- In 2020, we approved Rukobia (fostemsavir), the first in a new class of drugs to treat adults with HIV who have tried multiple HIV medications and whose infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations. Additionally, we approved Tivicay PD (dolutegravir), a new pediatric formulation that will help ensure earlier treatment for many babies and pediatric patients – an important part of HIV therapy.
It is gratifying for all of us at the FDA to reflect on this progress – and to appreciate that these accomplishments are the shared work of scientists, industry, regulators, patients, and advocates. Yet, as far as we’ve come, HIV/AIDS remains a global threat. As medical officers working on antiviral therapies at the FDA for many years, we are privileged to have been directly involved in most of these advances. We know we speak for our colleagues at the FDA, and many others in the medical community, when we say that our collective goal for a future World AIDS Day, is to announce a cure.