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tenofovir disoproxil orotate (Virreal)

✓ Approved

Dong-A ST · · Small Molecule

What is tenofovir disoproxil orotate?

tenofovir disoproxil orotate is a small molecule developed by Dong-A ST. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesVirreal
CompanyDong-A ST
Drug ClassSmall Molecule
Molecular Target,
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Dong-A ST

Mechanism of Action

Molecular Targets

tenofovir disoproxil orotate acts on 2 molecular targets:

gag-pol, HIV-1 (gag-pol)
(P)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

tenofovir disoproxil orotate is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsAcquired immunodeficiency syndrome✓ Approved
Infections and infestationsHepatitis B✓ Approved

Related Research Articles

PubMedFrontiers in immunology2026-08-25

Adjunctive albuvirtide is associated with improved immune recovery in treatment-naive patients with advanced HIV disease receiving bictegravir/emtricitabine/tenofovir alafenamide: a retrospective propensity score-matched cohort study.

Zhu Yingchun Y, Liu Huanxia H, Wang Yin Y, Wang Zongzheng Z et al.

Treatment-naive patients with advanced HIV infection may have incomplete immune reconstitution despite effective antiretroviral therapy (ART). We evaluated whether adjunctive albuvirtide (ABT) added to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) was associated with improved 24-week immune recovery and short-term safety. This single-center retrospective cohort included adults with baseline CD4+ T-cell counts <200 cells/μL who initiated ABT+B/F/TAF or B/F/TAF alone. Variable-ratio propensity score matching (up to 1:2) yielded 86 patients (33 receiving ABT+B/F/TAF and 53 receiving B/F/TAF). The primary endpoint was a composite of a CD4+ T-cell increase >150 cells/μL and HIV RNA <50 copies/mL at week 24. Secondary outcomes included virological suppression, changes in CD4+ T-cell count and CD4/CD8 ratio, and documented adverse events. A multivariable sensitivity analysis was performed in the complete unmatched cohort (N = 124). The composite endpoint was achieved more frequently with ABT+B/F/TAF than with B/F/TAF alone (45.5% vs. 22.6%, P = 0.027). The median CD4+ T-cell increase was also greater (165 vs. 106 cells/μL, P = 0.005). HIV RNA <20 copies/mL occurred in 75.8% versus 54.7% of patients, but the difference did not meet the prespecified significance threshold (P = 0.050). In the complete cohort, ABT+B/F/TAF remained associated with immune recovery after multivariable adjustment (adjusted OR = 6.355, 95% CI: 1.539-26.244; P = 0.011). Documented adverse events were similar between groups (54.5% vs. 50.9%, P = 0.732). No Grade ≥3 adverse events, treatment-related adverse events, or adverse-event-related treatment modifications were documented. Adjunctive ABT was associated with greater short-term immune recovery without an apparent increase in documented adverse events. The retrospective design, limited matched sample, residual confounding, and 24-week follow-up preclude causal inference. These findings require confirmation in prospective randomized trials.

PMID 42639035
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PubMedAIDS research and human retroviruses2026-08-25

Provider Preferences on Existing and Potential Future Biomedical HIV Prevention Products: A Qualitative Study in the United States, Thailand, and South Africa.

Tagliaferri Rael Christine C, Das Doyel D, Giguere Rebecca R, Porter Jonathan J et al.

Several forms of HIV pre-exposure prophylaxis (PrEP) are approved, prescribed off-label, or in development in the United States, including daily oral tablets, long-acting injectable cabotegravir (CAB-LA), removable implants, and rectal tenofovir products. To understand how health care providers prioritize among these options, 30 providers from the United States, Thailand, and South Africa completed online surveys, and 10 participated in in-depth interviews. Providers shared their perspectives on current and emerging PrEP products, key informational needs for gay and bisexual men, and preferred educational strategies. When asked to rank PrEP options if all were simultaneously available, providers most often prioritized removable implants (N = 3), daily oral PrEP (N = 3), CAB-LA (N = 1), and rectal douches/enemas (N = 1), while others (N = 2) emphasized patient preference. Overall, providers noted that each product has unique advantages and expressed support for digital shared decision-making tools to enhance patient-provider communication about PrEP selection.

PMID 42638181
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PubMedCureus2026-08-23

Delayed Multisystem Deterioration Following Large-Volume Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Overdose.

Javed Hamzah M HM, Cuello Sebastion S, Omer Muhammad M, Buryk Yaroslav Y

Genvoya is a fixed-dose antiretroviral medication commonly used in the treatment of human immunodeficiency virus (HIV) infection and is generally well tolerated. Severe toxicity following Genvoya overdose has not been well described, and currently available reports generally describe mild clinical courses managed with supportive care alone. We present the case of a 35-year-old male with HIV, hypertension, and amphetamine use who presented after intentional ingestion of approximately 90 tablets of Genvoya in a suicide attempt. He was initially awake, alert, and hemodynamically stable. Over the next 24 hours, however, he developed distributive shock requiring vasopressor support, acute hypoxic respiratory failure requiring high-flow nasal cannula oxygen therapy, metabolic acidosis, QTc prolongation, mild acute kidney injury, and newly reduced systolic cardiac function with an estimated ejection fraction of 25-35%. Chest imaging demonstrated pulmonary edema and volume overload. Infectious workup remained negative throughout admission. The patient was managed with supportive care in the medical intensive care unit and gradually improved over the following days. This case adds to the limited literature describing severe multisystem complications following large-volume Genvoya overdose.

PMID 42633490
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PubMedBrain, behavior, and immunity2026-08-21

Perinatal antiretroviral-associated cytokine and gut microbiota outcomes in deer mouse dams and their behaviorally diverse adult offspring.

Wolmarans De Wet W, Stroebel Jo-Anne JA, van der Sluis Rencia R, Sampson Timothy R TR et al.

Roll-out of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)-based pre-exposure prophylaxis (PrEP) for HIV prevention during pregnancy is increasing the number of infants perinatally exposed to antiretrovirals. Emerging evidence links perinatal antiretroviral (ART) and/or HIV exposure to later-life neurocognitive impairments, with oxidative stress, immune dysregulation and gut microbiota modification suggested as some of the major underlying role players. In human cohorts, disentangling the effects of exposure to maternal ART vs. maternal HIV on child development remains challenging. Thus, to address this gap, we investigated the impact of TDF/FTC on these biobehavioural outcomes in a controlled animal model. Using 60 female deer mice and their offspring, we assessed brain antioxidant defenses and immune signaling at 3-weeks-old and adulthood, gut microbiota composition at 3-weeks-old and adulthood, and nesting behavior during adulthood. Specifically, we sought to establish whether perinatal ART exposure alters oxidative stress, immune modulation, and gut microbiota composition and how these physiologies associate with adult psychobiological phenotypes, as reflected by nesting expression. Pregnancy and perinatal ART exposure significantly weakened brain antioxidant defenses and reduced brain tissue cytokine concentrations, while pregnancy also induced shifts in gut microbiota composition in female mice. Moreover, in offspring that exhibited orthogonal nesting behaviors in adulthood, perinatal ART exposure was distinctly associated with altered inflammatory signaling and gut microbiota composition. These findings suggest involvement of gut-immune-brain mechanisms as important modulators of the long-term impact of perinatal ART exposure on offspring neurobehavioral outcomes. This work also confirms the deer mouse as a valuable model for investigating naturalistic neurodevelopmental consequences of perinatal ART exposure.

PMID 42628700
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PubMedThe Journal of antimicrobial chemotherapy2026-08-21

Effectiveness of dolutegravir/lamivudine versus bictegravir/emtricitabine/tenofovir alafenamide in people with HIV with very high viral load (≥500 000 copies/mL).

Martin-Torres Juan J, Navarro-Soler Roser R, Iglesias-Franco Judit J, Lagarde-Sebastián María M et al.

To compare the effectiveness of dolutegravir/lamivudine (DTG/3TC) versus bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) at Week 48 in treatment-naive adults with high baseline viral loads (≥500 000 copies/mL) and CD4+ cell count ≥200/mm3 and to assess immune recovery and safety. We conducted a single-centre retrospective cohort study including all ART-naive people with HIV-1 (PWH) and HIV-RNA ≥500 000 copies/mL and CD4+ ≥200 cells/mm3 who initiated DTG/3TC or BIC/FTC/TAF during 2019-2024. Effectiveness was assessed as the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 [intention-to-treat, missing = failure (ITT, M = F)]. Immune recovery, metabolic and renal safety were evaluated through changes in CD4+ count, weight, lipid profile and creatinine. Time-to-virologic suppression was analysed using Kaplan-Meier curves and log-rank testing. Safety profile and immune recovery were conducted using Mann-Whitney U test. A total of 40 patients (52.5% on DTG/3TC, 47.5% on BIC/FTC/TAF) were included, with a high prevalence of primary HIV infection (PHI) (76.2% and 84.2%, respectively). No baseline differences were observed between groups. At 48 weeks, virologic suppression rates were 90.5% (19/21) in the DTG/3TC group and 94.7% (18/19) in the BIC/FTC/TAF group (log-rank P = 0.73). Viral decay kinetics were similar between groups. No virologic failures with resistance or treatment discontinuations were observed. Median CD4+ gains were comparable between groups (385 vs 243 cells/mm3; P = 0.30). No significant differences in weight gain, lipid profile, or creatinine levels were observed. In ART-naive PWH with HIV-RNA ≥500 000 cp/mL and CD4+ ≥200/mm3, including those with PHI, DTG/3TC and BIC/FTC/TAF showed similar effectiveness and comparable safety profiles at Week 48.

PMID 42627147
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PubMedThe Lancet regional health. Europe2026-08-20

Cost-effectiveness of lenacapavir versus tenofovir disoproxil fumarate plus emtricitabine for pre-exposure prophylaxis to prevent HIV-1 transmission in gay, bisexual, and other men who have sex with men in Spain.

Wikman-Jorgensen Philip Erick PE, Iniesta Carlos C, Ruiz-Algueró Marta M, Estrada Vicente V et al.

Lenacapavir (LEN), a twice-yearly subcutaneous capsid inhibitor, has demonstrated superior efficacy over daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as HIV pre-exposure prophylaxis (PrEP) in clinical trials. No European cost-effectiveness analyses have been published to date. We aimed to assess the cost-effectiveness of LEN versus TDF/FTC as PrEP for gay, bisexual, and other men who have sex with men (GBMSM) in Spain. We developed a deterministic, compartmental HIV dynamic transmission model stratified by age (from 16 up to 100 years) and four sexual-activity risk strata, calibrated to Spanish epidemiological data (2019-2023) using Latin Hypercube Sampling (100,000 runs) with local optimisation. Outcomes included quality-adjusted life-years (QALYs) and direct costs (2023€), both discounted at 3% annually over a 20-year horizon, from the Spanish National Health System perspective. Deterministic one-way sensitivity analysis (OWSA) and probabilistic sensitivity analysis (PSA; 1000 iterations) were conducted, alongside a price-threshold analysis. In the base case, LEN PrEP generated 2983 incremental QALYs at an incremental cost of €60.68 billion compared with TDF/FTC, yielding an incremental cost-effectiveness ratio (ICER) of €20,342,776 per QALY gained. At Spain's gross domestic product per capita willingness-to-pay threshold (€33,395/QALY), the vial price would need to fall from €21,088.55 to €769.36 per semi-annual injection to be cost-effective-a 96.4% reduction. In the PSA, the ICER of the means was €11,052,594/QALY and the probability of LEN PrEP being cost-effective was 0.001. LEN PrEP provides meaningful health benefits compared with TDF/FTC but at a cost far exceeding the accepted Spanish willingness-to-pay threshold. At current pricing, it is not cost-effective under any scenario examined and would require an approximate 96% price reduction to become cost-effective. While LEN represents a promising long-acting HIV prevention strategy, its population-level value is currently constrained by affordability. Substantial price reductions will likely be required to enable equitable access and realise its full public health potential. None.

PMID 42621308
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