ViiV HEALTHCARE SHOWCASES LONG-ACTING HIV INNOVATION AND POTENTIAL OF ULTRA LONG-ACTING PIPELINE, INCLUDING NEW DATA FOR FIRST THIRD-GENERATION INTEGRASE INHIBITOR AT CROI 2026
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- First-in-human data for long-acting formulations of VH184, the first third-generation integrase inhibitor, and early data for capsid inhibitor VH499 to be presented, highlighting progress in ViiV’s ultra long-acting pipeline
- 12-month data to be presented for investigational lotivibart (N6LS) + cabotegravir long-acting, evaluating feasibility of ultra long-acting dosing intervals
- Clinical data and real-world evidence from ViiV’s innovative portfolio include insights for established INSTI-based long-acting Cabenuva (cabotegravir + rilpivirine LA) and 2-drug regimen Dovato (dolutegravir/lamivudine)
London, 17 February 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders,* today announced data presentations from its innovative HIV treatment and prevention portfolio and integrase inhibitor (INSTI)-led pipeline at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, Colorado from 22-25 February.
Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “We are making major advances towards new ultra long‑acting regimens that build on ViiV’s legacy of integrase inhibitors, including pipeline assets such as VH184 that have the potential to extend dosing intervals to four months or longer – beyond what is available today for HIV treatment. Listening to the needs of the HIV community shapes our research and development, and the breadth of clinical and real‑world data we are presenting at CROI 2026 reflects our commitment to delivering long‑acting therapies that people impacted by HIV need and want.”
Key data to be presented at CROI 2026 by ViiV Healthcare and study partners include:
Advancing the next generation of ultra long‑acting (ULA) HIV treatment candidates: For VH184, the first third-generation INSTI, data from the ongoing first-in-human phase I study of injectable long-acting formulations will provide insights into its ULA potential in future regimens,1 while an additional analysis evaluates its in-vitro resistance profile vs bictegravir.2
Additionally, an interim analysis from the phase IIb EMBRACE study will report long-term data on HIV suppression and safety at 12 months with lotivibart (N6LS), an investigational broadly neutralising antibody administered every four months, in combination with monthly long-acting cabotegravir (CAB LA) for HIV treatment.3 Additional presentations illustrate data that will inform dosing and ULA feasibility of the injectable HIV‑1 capsid inhibitor, VH499.4,5
Exploring longer‑interval HIV prevention with cabotegravir ULA: The phase I CAB ULA 012 study explores dose selection of cabotegravir ULA, to support administration every four months, and informs the path toward expanded prevention choices.6
Expanding evidence across different populations for Cabenuva (cabotegravir + rilpivirine LA), the only complete long-acting injectable HIV treatment: Late-breaking results from the phase IIIb VOLITION study will provide an update on Month 11 outcomes among ART-naïve adults who chose to switch to cabotegravir + rilpivirine (CAB+RPV) LA (branded as Vocabria + Rekambys outside the US, Canada and Australia) immediately after achieving virologic suppression on once daily Dovato (dolutegravir/lamivudine (DTG/3TC)).7 Additionally, analyses from the real-world OPERA cohort will report virologic outcomes by body mass index categories for individuals suppressed at CAB+RPV LA initiation and four-year follow-up results for individuals initiating CAB+RPV LA with viral loads ≥50 vs <50 copies/mL.8,9
New evidence supporting CAB LA for PrEP and understanding PrEP uptake: An updated analysis from the phase I CLARITY study will provide detail on acceptability, visibility and size of injection‑site reaction nodules following single-dose lenacapavir and cabotegravir injections, supporting informed choice.10 Data from the OPERA cohort will outline Apretude (CAB LA for PrEP) effectiveness over three years, as well as coverage vs oral PrEP in routine care, providing important insights to guide implementation and adherence support.11,12 Twelve-month real-world effectiveness and acceptance data for CAB LA for PrEP among Black women, a group disproportionately impacted by HIV, will also be presented.13
Strengthening evidence for dolutegravir-based treatment across populations: The first efficacy meta-analysis between DTG/3TC vs DTG three drug regimens in ART-naïve people with high or very high viral load and/or low CD4 will be presented.14 Several analyses from PASO DOBLE, the largest head-to-head randomised clinical trial of DTG/3TC vs bictegravir, emtricitabine and tenofovir alafenamide (BIC/FTC/TAF), will provide insights on the differential metabolic impact including steatotic liver disease and adipose tissue at 96 weeks.15,16,17 Results from the SUNGURA study including safety and efficacy data in virally supressed older people living with HIV (≥60 years), switching to DTG/3TC from BIC/FTC/TAF will also be presented.18
Advancing paediatric treatment with LA options and DTG-based regimens: Week 96 and end-of-study results for adolescents (IMPAACT 2017; MOCHA), and first safety and pharmacokinetics data for children <20 kg (IMPAACT 2036; CRAYON) – from two of our registrational supported collaborative studies – illustrate CAB+RPV LA treatment strategies in younger age groups.19,20 Findings from an additional study from Southern Africa will describe viral suppression in children aged ≤5 years on DTG, highlighting its role in paediatric treatment.21 Results from PENTA 21 will explore non-inferiority of the simplified oral regimen DTG/3TC vs 3-drug ART in treating children.22
Key ViiV Healthcare sponsored or supported studies to be presented at CROI 2026:
| Title | Presenting author |
Oral abstract session |
| CAB+RPV LA Treatment | ||
| Long-Acting Cabotegravir + Rilpivirine in Adolescents: IMPAACT 2017 Week 96 & End of Study Results | A. Gaur | Oral Presentation Next-Generation HIV Strategies for Children and Adolescents: Breakthroughs in Pediatric HIV Prevention, Treatment, and Care 24 February 2026 |
| DTG/3TC | ||
| DTG/3TC is Non-Inferior to DTG-based 3-Drug ART in Children with HIV: D3/Penta 21 Week 96 Results | A. Turkova | Oral Presentation Next Generation HIV Strategies for Children and Adolescents: Breakthroughs in Pediatric HIV Prevention, Treatment, and Care 24 February 2026 |
| Lotivibart (N6LS) | ||
| Maintenance of HIV Suppression at 12 Months With VH3810109 (N6LS) Q4M + CAB LA QM: The EMBRACE Study | C.P. Rolle | Oral Presentation Extending the Reach: Long-Acting Antiviral and Novel Delivery 25 February 2026 |
| VH184 | ||
| Pharmacokinetics and Evaluation of Potential Dosing Regimens for Long-Acting VH4524184 | H. Back | Oral Presentation Extending the Reach: Long-Acting Antiviral and Novel Delivery 25 February 2026 |
| VH499 | ||
| Injectable HIV-1 Capsid Inhibitor VH4011499 (VH-499) Formulation Supports Ultra-Long-Acting Dosing | N. Thakkar | Oral Presentation Extending the Reach: Long-Acting Antiviral and Novel Delivery 25 February 2026 |
| Title | Presenting author |
Poster abstract session |
| CAB+RPV LA Treatment | ||
| Early Switch to CAB+RPV LA in Treatment-Naive Adults With HIV-1: Month 11 Outcomes From VOLITION | B. Jones | Poster (G-04) Cabotegravir and Rilpivirine in the "Real World" |
| Outcomes for Individuals who Initiate CAB+RPV LA in OPERA with Viral Loads ≥50 vs. <50 copies/mL | R. K. Hsu | Poster (G-04) Cabotegravir and Rilpivirine in the "Real World" 25 February 2026 |
| Body Mass Index and Virologic Outcomes in Individuals on CAB+RPV LA in the OPERA Cohort | M. G. Sension | Poster (G-04) Cabotegravir and Rilpivirine in the "Real World" 25 February 2026 |
| Safety And Pharmacokinetics of Long-Acting Cabotegravir and Rilpivirine in Young Children 10 - <40kg | M. Archary | Poster (P-04) Pharmacokinetics, Safety, and Use of ARVs, Old and New, in Infants, Children, and Adolescents 24 February 2026 |
| CAB LA for PrEP | ||
| Dose Selection of Ultra-Long-Acting Cabotegravir as HIV-1 Pre-Exposure Prophylaxis: A Phase 1 Study | E. Castronova | Poster (F-02) Going the Distance: Pharmacokinetics of Next-Generation Long-Acting Agents 24 February 2026 |
| Injection Site Reactions More Common and Bothersome with Single Doses of Lenacapavir vs Cabotegravir | K. Brown | Poster (S-01) Who is Using Injectable PrEP, and How's That Going? 24 February 2026 |
| Cabotegravir LA for PrEP: Progress in HIV Prevention from Three Years of OPERA Data | R. Hsu | Poster (S-01) Who is Using Injectable PrEP, and How's That Going? 24 February 2026 |
| Comparing PrEP coverage and HIV acquisition between CAB LA and oral PrEP in the OPERA cohort | S. Barnett | Poster (S-01) Who is Using Injectable PrEP, and How's That Going? 24 February 2026 |
| EBONI M12 Results: High Real-World Effectiveness and Acceptance of CAB LA for PrEP in Black Women | Z. Tims-Cook | Poster (U-05) Special Populations 24 February 2026 |
| DTG/3TC | ||
| Effect of DTG/3TC vs. BIC/FTC/TAF on Steatotic Liver Disease: 96-week Analysis of PASO-DOBLE Trial | J. Pineda | Themed Discussion and Poster (I-02) Extra Large Challenges in Steatotic Liver Disease 24 February 2026 |
| CD4/CD8 T Cell Telomere Length at 96 Weeks in the PASO-DOBLE Trial Comparing BIC/FTC/TAF and DTG/3TC | A. Esteban-Cantos | Poster (L-03) Biomarkers of Aging 24 February 2026 |
| Transcriptomic Changes in Adipose Tissue of People with HIV on BIC/FTC/TAF or DTG/3TC Treatment | P. Domingo | Poster (L-01) Weight Gain and Metabolic Disorders 23 February 2026 |
| Efficacy and safety of switching to DTG/3TC dual therapy from B/F/TAF among older adults ≥60 years | L. A. Ombajo | Poster (G-02) TLD and HIV Treatment in LMIC: What Are We Learning? 23 February 2026 |
| Meta-analysis of DTG/3TC vs DTG 3DRs in ART-Naive People With High Baseline Viral Loads and Low CD4+ | P. Patel | Poster (G-05) Clinical Trials and Observational Studies of Antiretroviral Therapy 25 February 2026 |
| DTG | ||
| Viral Suppression with Dolutegravir-Based Regimens in Children ≤5 Years Old in Southern Africa | K. Anderson | Poster (P-05) Viral Suppression and Drug Resistance in Children and Adolescents With HIV 25 February 2026 |
| VH184 | ||
| Third-Generation INSTI VH4524184 (VH-184) Has an Enhanced Resistance Profile vs Bictegravir | J. L. Jeffrey | Poster (H-01) Integrase Resistance 23 February 2026 |
| VH499 | ||
| Population PK and Exposure-Response Analysis of Orally Administered VH4011499 in people living with HIV-1 | N. Thakkar | Poster (F-02) Going the Distance: Pharmacokinetics of Next-Generation Long-Acting Agents 24 February 2026 |
APRETUDE (cabotegravir) extended-release injectable suspension
Professional Indication and Important Safety Information
INDICATION
APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
CONTRAINDICATIONS
- Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
- Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
- Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
- When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
- Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
- Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE
Potential Risk of Resistance with APRETUDE:
- There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE
Long-Acting Properties and Potential Associated Risks with APRETUDE:
- Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE
- Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated
Hepatotoxicity:
- Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
- Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated
Depressive Disorders:
- Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
- Promptly evaluate patients with depressive symptoms
Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:
- The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
- Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
DRUG INTERACTIONS
- Refer to the full Prescribing Information for important drug interactions with APRETUDE
- Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
USE IN SPECIFIC POPULATIONS
- Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
- Pediatrics: Not recommended in individuals weighing less than 35 kg
For more information, please see full US Prescribing Information for APRETUDE: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF
CABENUVA (cabotegravir; rilpivirine) extended-release injectable suspensions
Professional Indication and Important Safety Information
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA
- Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries
- Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction
- Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection
- Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated
Hepatotoxicity:
- Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors
- Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations
- Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected
Depressive Disorders:
- Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation, suicide attempt) have been reported with CABENUVA or the individual products
- Promptly evaluate patients with depressive symptoms
- Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:
- The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions)
- Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
Long-Acting Properties and Potential Associated Risks with CABENUVA:
- Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance
- To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible
ADVERSE REACTIONS
- The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash
- The safety of CABENUVA in adolescents is expected to be similar to adults
DRUG INTERACTIONS
- Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)
- Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine
- CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes
USE IN SPECIFIC POPULATIONS
- Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established
- Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
For more information, please see full US Prescribing Information for CABENUVA: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Cabenuva/pdf/CABENUVA-PI-PIL-IFU2-IFU3.PDF
DOVATO (dolutegravir and lamivudine) tablets
Professional Indication and Important Safety Information
INDICATION
DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1:
EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV
All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.
CONTRAINDICATIONS
- Do not use DOVATO in patients with previous hypersensitivity reaction to dolutegravir or lamivudine
- Do not use DOVATO in patients receiving dofetilide
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
- Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury
- Discontinue DOVATO immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated
Hepatotoxicity:
- Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors
- Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of DOVATO. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn
- Monitoring for hepatotoxicity is recommended
Embryo Fetal Toxicity:
- Assess the risks and benefits of DOVATO and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects
- Pregnancy testing is recommended before initiation of DOVATO. Individuals of childbearing potential should be counseled on the consistent use of effective contraception
Lactic Acidosis and Severe Hepatomegaly With Steatosis:
- Fatal cases have been reported with the use of nucleoside analogs, including lamivudine.
- Discontinue DOVATO if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of DOVATO and other drugs may occur (see Contraindications and Drug interactions).
Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of DOVATO.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%, all grades) with DOVATO were headache (3%), nausea (2%), diarrhea (2%), insomnia (2%), fatigue (2%), and anxiety (2%).
DRUG INTERACTIONS
- Consult full Prescribing Information for DOVATO for more information on potentially significant drug interactions
- DOVATO is a complete regimen. Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended
- Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of dolutegravir
- Administer DOVATO 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, DOVATO and supplements containing calcium or iron can be taken with food
Use in specific populations
- Pregnancy: There are insufficient human data on the use of DOVATO during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. Advise individuals of childbearing potential of the potential risk of neural tube defects. Assess the risks and benefits of DOVATO and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy or if pregnancy is confirmed in the first trimester
- Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant
- Females and Males of Reproductive Potential: Pregnancy testing is recommended before initiation of DOVATO. Counsel individuals of childbearing potential taking DOVATO on the consistent use of effective contraception
- Renal Impairment: DOVATO is not recommended for patients with creatinine clearance <30 mL/min. Patients with a sustained creatinine clearance between 30 and 49 mL/min should be monitored for hematologic toxicities, which may require a dosage adjustment of lamivudine as an individual component
- Hepatic Impairment: DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C)
For more information, please see full US Prescribing Information for DOVATO:
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About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q4 Results for 2025.
Registered in England & Wales:
GSK plc ViiV Healthcare Limited
No. 3888792 No. 06876960
Registered Office:
79 New Oxford Street ViiV Healthcare Limited
London GSK Medicines Research Centre
WC1A 1DG Gunnels Wood Road, Stevenage
United Kingdom
SG1 2NY
*On 20 January 2026, GSK plc and Shionogi & Co., Ltd announced that they have reached agreement together with Pfizer Inc. for the economic interest in ViiV Healthcare Limited currently held by Pfizer to be replaced with an investment by Shionogi. Completion of the transaction is subject to certain regulatory clearances in relevant markets, and is expected to occur during the first quarter of 2026.
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