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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 medicine2026-10-15

Season-adjusted longitudinal changes in serum 25-hydroxyvitamin D during pegylated interferon add-on to ongoing tenofovir alafenamide therapy in chronic hepatitis B: a real-world cohort study.

Han Ning N, Liu Huan H, Zhu Xia X

To characterize serum 25-hydroxyvitamin D [25(OH)D] trajectories during peginterferon alfa-2b (Peg-IFN) add-on to ongoing tenofovir alafenamide (TAF) therapy in chronic hepatitis B and explore associations with hepatitis B surface antigen (HBsAg). This retrospective cohort identified 203 consecutive patients, of whom 190 contributed longitudinal data through week 48. The primary random-intercept mixed-effects model used categorical visit time and adjusted for seasonality, age, and sex. Continuous-time, random-slope, visit-timing, and HBsAg-censoring analyses assessed sensitivity. The primary adjusted week-48 25(OH)D difference was -7.9 nmol/L (95% CI, -9.8 to -6.0) (P < 0.001); the secondary continuous-time estimate was -8.3 nmol/L over 48 weeks. Observed concentrations declined through week 36 and partially rebounded at week 48. The proportion below 47.7 nmol/L increased from 21.1% to 34.7%. The adjusted total serum calcium trend was -0.061 mmol/L (95% CI, -0.074 to -0.049). Triglycerides increased while cholesterol fractions decreased. At week 48, 104/190 patients (54.7%) had an HBsAg decline of at least 1 log10 and 50/190 (26.3%) had visit-specific HBsAg loss. The concurrent 48-week change correlation was weak (ρ = 0.150; FDR-adjusted P = 0.117), and the magnitude of 25(OH)D decline was not independently associated with either binary endpoint. Within patients, each 10 nmol/L increase in 25(OH)D was associated with a 0.068-log10 IU/mL increase in concurrent HBsAg (95% CI, 0.020 to 0.116; P = 0.006). Serum 25(OH)D showed a non-linear decline during 48 weeks of follow-up, and the week-48 difference remained evident after adjustment for seasonality. However, without a concurrent comparator, the observed change cannot be attributed specifically to Peg-IFN, TAF, or their combination. Exploratory analyses suggested only a weak concurrent relationship between 25(OH)D and HBsAg, without evidence of prediction or causality. The clinical relevance of the observed changes in 25(OH)D and total serum calcium warrants further prospective investigation.

PMID 42876729
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PubMedJournal of the International Association of Providers of AIDS Care2026-10-14

Clinical Outcomes of Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in People Living With HIV and Low-Level Viraemia.

de Los Santos Ignacio I, Pousada Guillermo G, Galera Carlos C, Dueñas Carlos C et al.

IntroductionLow-level viraemia (LLV) in people living with HIV (PLWH) remains a clinical challenge, associated with increased risk of virological failure, immune dysregulation, and chronic inflammation. Bictegravir/emtricitabine/tenofovir alafenamide is a single-tablet regimen with a high genetic barrier to resistance, but real-world outcomes after switching in PLWH with LLV remain insufficiently characterized. This study aimed to describe virological, immunological, metabolic, and safety outcomes after switching to bictegravir/emtricitabine/tenofovir alafenamide in PLWH with documented LLV over 96 weeks.MethodsA retrospective, multicentre study was conducted across 12 Spanish healthcare centres. PLWH aged ≥18 years with a documented qualifying LLV episode before switch (two consecutive HIV-1 RNA measurements between 50 and 400 copies/mL) who switched to bictegravir/emtricitabine/tenofovir alafenamide were included (N = 123). Outcomes included virological suppression (<50 copies/mL), residual LLV, CD4+/CD8+ dynamics, metabolic changes, and safety. Analyses were descriptive, used observed denominators, and included a non-completer=failure sensitivity analysis for virological suppression.ResultsAmong participants (median age: 52 years, 80.5% male; median time since HIV diagnosis: 30 years), observed LLV decreased to 11.4% (13/114 patients) at 96 weeks after switching to bictegravir/emtricitabine/tenofovir alafenamide (p<0.001). In the non-completer=failure sensitivity analysis, virological suppression at week 96 was 82.1% (101/123). At week 96, all detectable HIV-1 RNA values were 55-272 copies/mL; 3/13 patients had LLV at all available 24-, 48-, and 96-week visits. CD4+/CD8+ ratios remained stable, with a significant reduction in CD8+ T cell counts in patients ≥50 years. Biochemical markers were broadly stable, but weight/BMI increases and a shift toward overweight were observed and warrant monitoring. No treatment discontinuations due to adverse events were reported.ConclusionIn this single-arm retrospective cohort, switching to bictegravir/emtricitabine/tenofovir alafenamide was associated with a high observed proportion of virological suppression, immune stability, and favourable tolerability over 96 weeks; however, causal effectiveness cannot be inferred. These findings support further comparative prospective evaluation of bictegravir/emtricitabine/tenofovir alafenamide for LLV management.

PMID 42874079
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PubMedJournal of acquired immune deficiency syndromes (1999)2026-10-14

Developing a drug-level feedback adherence counseling intervention for young MSM in the U.S.

Mahuvakar Shivani S, Argueta-Rodriguez Juan J, Montoya Rikki R, Ghanooni Delaram D et al.

Young men who have sex with men (MSM) in the U.S. have suboptimal adherence to oral tenofovir-based pre-exposure prophylaxis (PrEP), undermining HIV prevention goals. Drug-level feedback using urine point-of-care tenofovir assays has improved adherence in Eastern and Southern African settings but has not been assessed among U.S. MSM. Community-based PrEP clinic in San Francisco and home-based remote counseling sessions among young MSM across the U.S. A two-phase study was conducted. Phase 1 involved qualitative interviews with 20 young MSM (mean age 25.7 years) from a San Francisco PrEP clinic, guided by the COM-B model and Behavior Change Wheel framework to identify barriers to adherence, informing the development of the PrEP2-BAY intervention. Phase 2 pilot-tested the PrEP2-BAY intervention remotely among 20 MSM (mean age 27.7 years), using at-home urine tenofovir tests and counselor-led feedback and action planning via Zoom. Acceptability was assessed qualitatively through the Theoretical Framework of Acceptability. Urine tenofovir levels were compared pre- and post-intervention. Key barriers to PrEP adherence identified included mental health, substance use, relationship dynamics, and stigma. Participants preferred at-home testing with counselor guidance, leading to adaptation of PrEP2-BAY into an mHealth approach. In the pilot phase, participants reported high acceptability and perceived effectiveness. There was a trend toward improved urine tenofovir levels with all participants exhibiting positive urine test results post-intervention. PrEP2-BAY demonstrated high acceptability with a trend toward improved adherence among young MSM. Further evaluation through a randomized controlled trial is recommended to assess efficacy and support broader implementation.

PMID 42872824
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PubMedCanadian liver journal2026-10-14

Hepatitis B reactivation in HBsAg-/anti-HB-negative patients diagnosed with hematological malignancy: A case series.

Tharmaratnam Tharmegan T, Vakili Sanam Tabataba ST, Li Daniel D, Aleyadeh Wesam W et al.

Hepatitis B virus (HBV) reactivation is a well-recognized complication of immunosuppressive therapy in patients with hematologic malignancies. It usually occurs in those with chronic or resolved HBV infection identified by positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc). Reactivation in patients who test negative for both markers is exceedingly rare and poses a diagnostic challenge. We report on three patients with hematologic malignancies who developed HBV reactivation despite negative baseline serology. Cases were identified and managed at a tertiary liver centre in Canada. Clinical, virologic, and treatment data were reviewed, including HBV serology, viral load, chemotherapy exposure, and outcomes following antiviral therapy. All three patients originated from HBV-endemic regions and had received potent immunosuppressive regimens, including B cell-depleting agents or hematopoietic stem cell transplantation. Two were completely seronegative (HBsAg-/anti-HBc-/hepatitis B surface antibody [anti-HBs]-negative), and one had isolated anti-HBs positivity that was subsequently lost before reactivation. HBV DNA became detectable months to years after treatment initiation. All patients received antiviral therapy with entecavir or tenofovir, resulting in viral suppression and biochemical recovery. This case series highlights a critical limitation of current HBV screening strategies that rely solely on antibody-based testing. Loss of humoral immunity may obscure prior HBV exposure, leading to unrecognized reactivation risk. Clinicians should maintain a high index of suspicion and consider serial ALT and HBsAg monitoring in immunosuppressed patients with humoral (B cell) immune deficiencies, particularly those from HBV-endemic regions.

PMID 42871860
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PubMedJournal of Korean medical science2026-10-13

Superior Efficacy of Besifovir in Reducing Hepatocellular Carcinoma Risk Compared to Tenofovir in Chronic Hepatitis B Patients: A Nationwide Cohort Study.

Shin Yoon E YE, Kim Jae Young JY, Kim Hyuk H, Yoo Jeong-Ju JJ et al.

Besifovir dipivoxil maleate (BSV) is a novel therapeutic option for the treatment of chronic hepatitis B (CHB). However, its long-term effectiveness in reducing the risk of hepatocellular carcinoma (HCC) remains unclear. We conducted a retrospective cohort study using the Korean Health Insurance Review and Assessment Service database from 2018 to 2022. A total of 32,383 patients with CHB were included (BSV, n = 2,358; tenofovir disoproxil fumarate [TDF], n = 30,025). Propensity score matching was conducted at a 1:3 ratio to minimize selection bias. The primary outcome was the incidence of HCC, with cirrhosis development as the secondary endpoint. In the overall population, 57 cases of HCC were reported in the BSV group (2,358 individuals, 5,918 person-years), while 1,268 cases of HCC were reported in the TDF group (30,025 individuals, 83,587 person-years). After propensity score matching, the incidence of HCC was significantly lower in the BSV group (9.63 per 1,000 person-years; 95% confidence interval [CI], 7.43-12.49) than in the TDF group (15.36 per 1,000 person-years; 95% CI, 13.72-17.18), with an incidence rate ratio of 1.59 (P = 0.001). This protective effect remained consistent in both cirrhotic (hazard ratio [HR], 1.609; P = 0.028) and non-cirrhotic subgroups (HR, 1.831; P = 0.002). BSV treatment demonstrated superior efficacy in reducing the risk of HCC compared to TDF, regardless of baseline cirrhosis status. These findings suggest that BSV may provide enhanced protection against HCC in patients with CHB.

PMID 42865284
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PubMedToxicology2026-10-13

Perturbation of metabolic pathways associated with exposure of human renal proximal tubular cells to nephrotoxic pollutants and drugs.

Lash Lawrence H LH, Hu Xin X, Mathieu Patricia A PA, Gargano Mary D MD et al.

Mammalian kidneys, although exposed to a diverse array of environmental pollutants and commonly used drugs that are dose-limited by nephrotoxicity, have a significant but limited capacity for repair and regeneration. Primary cultures of human proximal tubular (hPT) cells were used to investigate the cellular response to exposures to one of two environmental toxicants (mercuric chloride [HgCl2] or S-(1,2-dichlorovinyl)-L-cysteine [DCVC; key metabolite of trichloroethylene] or one of three nephrotoxic drugs (cisplatin [CDDP], polymyxin B [PmxB], tenofovir disoproxil fumarate [TDF]) at concentrations that cause no to modest cellular injury. Cellular phenotype was first characterized by measuring protein expression of key drug metabolism enzymes and plasma membrane transporters. To enable identification of biomarkers when the hPT cells are still capable of repair and regeneration, release of Kidney Injury Molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) from exposed hPT cells was determined. Results validated that for each of the 3 concentrations of the 5 toxicants or drugs tested at the 3 time points, there was either no significant pattern of or modest cellular injury. Untargeted metabolomics was conducted to identify high resolution mass spectrometry features representing metabolites that differ after exposures. Pathway analysis was then conducted to map these metabolites into altered pathways. Prostaglandin metabolism from arachidonate, multiple fatty acid metabolism pathways, several amino acid metabolism pathways, and pentose phosphate and related vitamin metabolism pathways were the most common pathways altered by all 5 chemicals. Detection of these altered pathways can be used as indicators to identify renal injury and promote repair.

PMID 42863561
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