Human immunodeficiency virus (HIV) remains one of the most studied infectious diseases in modern medicine. Although no widely applicable cure has been approved yet, the landscape of HIV prevention and treatment continues to evolve rapidly — with significant recent approvals and ongoing cutting-edge research aiming to transform the lives of both people living with HIV and those at risk of infection.
- Traditional Antiretroviral Therapy (ART): The Standard of Care
Since the first antiretroviral drugs in the late 1980s, the FDA has approved a broad range of antiretroviral medications that have turned HIV from a fatal condition into a chronic, manageable disease when treated properly. These drugs work by suppressing viral replication, maintaining immune function, and reducing the risk of transmission. ART typically involves a combination of drugs from different classes, such as:
- Reverse Transcriptase Inhibitors (e.g., doravirine, lamivudine, tenofovir combinations)
- Integrase Inhibitors (e.g., bictegravir, dolutegravir)
- Protease Inhibitors (e.g., darunavir used with boosters)
Some of these combinations are available as single-tablet regimens, making adherence easier and improving long-term outcomes. The National Institutes of Health maintains a regularly updated list of all FDA-approved HIV medicines used in current treatment regimens.
- Pre-Exposure Prophylaxis (PrEP): Preventing HIV Before It Occurs
A major breakthrough in HIV prevention occurred with the FDA’s June 2025 approval of lenacapavir — marketed as Yeztugo® — as a long-acting PrEP option that only needs to be administered twice a year.
Unlike daily oral PrEP pills such as Truvada or Descovy, lenacapavir is a capsid inhibitor that disrupts HIV’s ability to replicate and has demonstrated near-100 % effectiveness in large clinical trials for HIV prevention in adults and adolescents at high risk.
This approval is significant because it could markedly improve adherence — a longstanding challenge with daily medication — and potentially reduce incident infections if made accessible at scale.
- Long-Acting Treatment Options
For people living with HIV, long-acting injectable therapies have been a game changer:
- Cabotegravir (Apretude) — a long-acting integrase inhibitor — has been FDA-approved for injection every two months and offers an alternative to daily pills.
Such injections improve convenience and reduce issues around adherence, which is critical in sustained viral suppression. Emerging regimens combining long-acting agents (like experimental bictegravir/lenacapavir combinations) may broaden options further and could be submitted for regulatory approval soon.
- What About a Cure? Stem Cells and Beyond
The concept of an HIV cure — meaning elimination or long-term remission of the virus without ongoing ART — remains one of the field’s greatest scientific ambitions. While the FDA has not approved a broadly applicable cure yet, there are significant scientific milestones and experimental approaches worth noting:
Stem Cell Transplantation and HIV Remission
A small number of individuals have achieved sustained HIV remission following stem cell transplants carried out for cancer treatment. These patients, including the original “Berlin Patient” and several others reported globally, received hematopoietic stem cells from donors with mutations in the CCR5 HIV-entry co-receptor, making new immune cells resistant to most HIV strains.
In a recent highlighted case, a seventh person has remained free of detectable HIV for years following a transplant, even with donor cells that carried only one copy (heterozygous) of the CCR5 delta-32 mutation — an intriguing insight that may broaden future therapeutic strategies.
However, stem cell transplants are not FDA-approved as a general HIV cure, mainly because they require intensive conditioning (chemotherapy, radiation), carry significant risks (e.g., graft-versus-host disease), and are only justified when treating life-threatening conditions like leukemia.
Gene Therapy and CRISPR Approaches
Another promising frontier involves gene-editing techniques designed to make patients’ own stem cells or immune cells resistant to HIV or to remove viral DNA permanently from infected cells. For instance, Excision BioTherapeutics’ EBT-101 — a CRISPR-based therapy targeting HIV proviral DNA — received Fast Track designation from the FDA, indicating expedited development and review due to its potential to transform treatment.
While these therapies are still in early clinical trials and are not yet approved, they represent the most tangible routes toward a functional or sterilizing cure in the long term.
- Prakasine and Future Perspectives
Emerging compounds — such as Prakasine, described by its proponents as a novel non-toxic mercury-based nanomedicine — are being discussed in research and alternative medicine forums as potential adjuncts in HIV therapy. While such agents may generate scientific interest, they are not FDA-approved treatments for HIV at this time and should be considered experimental until robust clinical evidence and regulatory review confirm safety and efficacy.
Conclusion
As of 2026, the FDA’s strategy for tackling HIV hinges on two pillars: availably safe, effective treatments that suppress viral replication and innovative prevention methods that reduce new infections. The landmark approval of long-acting injectable PrEP with lenacapavir represents a major step forward in prevention. Meanwhile, traditional ART regimens and long-acting treatment injections continue to make life with HIV more manageable.
The dream of a universally applicable cure remains on the horizon, with stem cell studies and gene-editing strategies offering promising scientific insights. As research advances, regulatory decisions — guided by rigorous evidence — will determine how and when truly curative therapies become a reality.