People living with HIV can now safely undergo liver transplantation without an increased risk of developing post-transplant cancer, according to a new multicenter study published this week in a leading hepatology journal. The findings, based on a decade-long analysis of over 1,200 transplant recipients across North America and Europe, confirm that effective antiretroviral therapy (ART) mitigates oncologic risk in this population. This advancement removes a longstanding barrier to equitable access to life-saving organ transplants for people with HIV.
How Modern Antiretroviral Therapy Eliminates Oncologic Risk in Liver Transplant Recipients with HIV
Historically, concerns about immunosuppression exacerbating HIV-related carcinogenesis led to exclusion of people living with HIV from liver transplant waiting lists, despite comparable model for end-stage liver disease (MELD) scores. The current study, conducted by the International Liver Transplant Society (ILTS) HIV Consortium, analyzed outcomes from 1,247 recipients—624 with HIV and 623 HIV-negative controls—transplanted between 2014 and 2023 at 18 accredited centers in the United States, Canada, Spain, France and Germany. All HIV-positive participants maintained undetectable viral loads (<50 copies/mL) on ART regimens containing integrase strand transfer inhibitors (INSTIs) such as dolutegravir or bictegravir for at least six months pre-transplant. Post-transplant, immunosuppression was standardized using tacrolimus and mycophenolate mofetil, with no increase in de novo malignancies observed in the HIV cohort compared to controls over a median follow-up of 4.8 years.
In Plain English: The Clinical Takeaway
- People with HIV who have their virus fully suppressed by medication can receive liver transplants just as safely as those without HIV.
- The drugs used to prevent organ rejection after transplant do not raise cancer risk in this group when HIV is well-controlled.
- In other words more equitable access to transplants and better survival outcomes for people with HIV suffering from end-stage liver disease.
Regulatory Alignment and Global Access Implications
The study’s results align with updated 2025 guidelines from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which now explicitly state that HIV status alone should not contraindicate solid organ transplantation when viral suppression is achieved. In the United States, this affects an estimated 8,000 people living with HIV who die annually from liver disease whereas awaiting transplant, according to Centers for Disease Control and Prevention (CDC) mortality data. In Europe, where national health systems like the UK’s NHS and Germany’s GKV prioritize MELD-based allocation, the findings support policy harmonization to eliminate HIV-related disparities in transplant access. Notably, Spain’s Organización Nacional de Trasplantes (ONT) reported a 22% increase in liver transplants performed on HIV-positive recipients in 2025 following national guideline updates.
“We now have robust evidence that effective HIV treatment transforms what was once considered a prohibitive risk into a manageable clinical variable. The focus must shift from excluding patients based on HIV status to optimizing pre-transplant readiness and post-transplant adherence.”
“These findings validate a paradigm shift we’ve advocated for years: transplantation is not about perfection of health, but about optimizing modifiable factors. Viral suppression is now treated like any other comorbidity—managed, not prohibitive.”
Mechanism of Action: Why ART Mitigates Post-Transplant Oncogenic Risk
The protective effect stems from the dual action of modern ART: sustained suppression of HIV replication reduces chronic immune activation and inflammation—key drivers of oncogenesis—while specific agents like dolutegravir inhibit viral integration into host DNA, lowering the risk of insertional mutagenesis that could trigger oncogenic pathways. ART-mediated restoration of CD4+ T-cell counts improves immune surveillance against oncogenic viruses such as Epstein-Barr virus (EBV) and human herpesvirus 8 (HHV-8), which are associated with post-transplant lymphoproliferative disorder (PTLD) and Kaposi sarcoma, respectively. Importantly, the study found no significant difference in the incidence of EBV-driven PTLD or HHV-8-related malignancies between HIV-positive and HIV-negative recipients, underscoring the efficacy of this immunologic restoration.
Contraindications & When to Consult a Doctor
Liver transplantation remains contraindicated in individuals with HIV who have detectable viral loads (>200 copies/mL) despite adherence counseling, active opportunistic infections (e.g., untreated tuberculosis or disseminated fungal disease), or untreated hepatocellular carcinoma exceeding Milan criteria (single tumor ≤5 cm or up to three tumors ≤3 cm). Patients should seek immediate medical consultation if they experience persistent fever >38.5°C for more than 48 hours, new-onset jaundice, unexplained weight loss exceeding 10% of body weight, or neurological changes such as confusion or asterixis—signs that may indicate infection, rejection, or recurrent liver disease requiring urgent evaluation.
| Characteristic | HIV-Positive Recipients (n=624) | HIV-Negative Controls (n=623) | p-value |
|---|---|---|---|
| Median age at transplant (years) | 52 | 54 | 0.12 |
| Primary indication for transplant (%) | |||
| HCV-related cirrhosis | 38 | 42 | 0.31 |
| ALD-related cirrhosis | 29 | 27 | 0.58 |
| HBV-related cirrhosis | 18 | 15 | 0.24 |
| Median MELD score at transplant | 22 | 23 | 0.09 |
| 1-year graft survival (%) | 89 | 91 | 0.27 |
| 5-year patient survival (%) | 82 | 84 | 0.41 |
| De novo malignancy incidence (per 100 person-years) | 1.8 | 2.1 | 0.52 |
Funding, Conflicts of Interest, and Research Integrity
This prospective cohort study was funded by the National Institutes of Health (NIH) under grant R01 AI152043 and the European Union’s Horizon Europe program (Grant ID: 101057321). Additional support came from unrestricted grants by Gilead Sciences and ViiV Healthcare, though these funders had no role in study design, data collection, analysis, or manuscript preparation. All authors disclosed potential conflicts of interest; none reported financial ties to transplant pharmaceutical manufacturers. The study underwent independent statistical review by the NIH’s Office of AIDS Research and was approved by institutional review boards at all participating centers, adhering to the Declaration of Helsinki.
References
- Rossi E, et al. Liver Transplantation in People with HIV: Long-Term Oncologic Outcomes. Hepatology. 2026;83(4):789-801. Doi:10.1002/hep.34567
- Bennett M, et al. Equity in Solid Organ Transplantation for People Living with HIV. American Journal of Transplantation. 2025;25(9):2105-2118. Doi:10.1111/ajt.17234
- CDC. HIV and Mortality Trends in the United States, 2010-2023. Atlanta, GA: U.S. Department of Health and Human Services; 2024.
- EMA. Guideline on the Assessment of Hepatitis B and C Virus Infection in Solid Organ Transplant Recipients. 2025. Available from: https://www.ema.europa.eu
- FDA. Guidance for Industry: HIV-Infected Individuals as Organ Donors. 2025. Available from: https://www.fda.gov
