ViiV HEALTHCARE DATA SHOW 89% OF TREATMENT-NAÏVE PEOPLE WITH HIV CHOOSE TO SWITCH TO LONG-ACTING INJECTABLE VOCABRIA + REKAMBYS FROM DAILY PILLS AFTER ACHIEVING RAPID VIRAL SUPPRESSION

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  • Multiple real-world studies show consistent high effectiveness of Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) across a broad range of populations
  • Implementation science data for Apretude (cabotegravir long-acting (CAB LA) for PrEP) demonstrate 95% of participants were happy they switched from oral PrEP to CAB LA

London, 14 July, 2025 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced data from the phase IIIb VOLITION study demonstrating that 89% (n=129/145) of eligible treatment-naïve people living with HIV living with HIV opted to switch to long-acting injectable Vocabria + Rekambys (branded as Cabenuva in the US, Canada and Australia) following rapid viral suppression with daily Dovato (dolutegravir/lamivudine (DTG/3TC)). Additional real-world data from other studies reinforce CAB+RPV LA’s effectiveness across a broad range of populations.

Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “Data from the VOLITION study highlight how providing choice in HIV care empowers individuals to choose medicines that meet their evolving everyday needs. ViiV pioneered long-acting injectables for HIV, and we now have over three years of robust real-world evidence demonstrating the impact our portfolio is having today across a broad range of settings and populations. Long-acting injectables provide options that can offer high effectiveness and tolerability, improved adherence, and a preferred dosing schedule compared with daily oral pills. We believe they are a key part of HIV treatment and prevention and will play a critical role in achieving our ambition of ending HIV and AIDS.”

Data summary from ViiV Healthcare and partner studies at IAS 2025:

Empowering choice: 89% of treatment-naïve people with HIV opt for CAB+RPV LA after achieving rapid viral suppression: These new data from the phase IIIb VOLITION study evaluate the experience of treatment-naïve individuals who initiated treatment with daily DTG/3TC pills and were subsequently offered the choice to switch to CAB+RPV LA after achieving viral suppression. Study results showed that participants achieved rapid viral suppression with DTG/3TC (median time to suppression: 4.14 weeks), following which they were offered to switch. At the immediate next study visit (Day of Choice), 89% (n=129/145) of eligible participants chose to switch to CAB+RPV LA, while 11% (n=16) opted to continue DTG/3TC. The most common reasons cited for choosing CAB+RPV LA were not having to worry about missing a dose each day (80%) and not having to carry medication (68%). These findings underscore the efficacy and tolerability of DTG/3TC as a rapid suppression option, and demonstrate the value of offering CAB+RPV LA as a treatment option to meet individual needs and preferences.1

CAB+RPV LA delivers sustained effectiveness and enhanced patient experience in real-world settings: Data from multiple real-world observational studies, including the two-year BEYOND study in the US, the CARLOS study in Germany, the COMBINE-2 cohort across seven European countries, and the OPERA study, consistently reinforce the high effectiveness, favourable outcomes and patient satisfaction associated with CAB+RPV LA.2,3,4,5,6,7

BEYOND is a two-year prospective observational study enrolling people with HIV following the decision to switch to CAB+RPV LA across 27 US sites.2 Among the 308 participants, 97% maintained virologic suppression at Month 24 (at most recent viral load of <50 copies/ml), with infrequent discontinuations due to injection reactions and no new confirmed virologic failures after Month 6. Participants reported reduced stigma and improved treatment satisfaction.3

Similarly, the real-world CARLOS study of 351 participants in Germany, showed 77.5% virologic suppression at Month 24, with high adherence (94.2% on-time injections) and clinically meaningful improvements in treatment satisfaction.4 97.7% of participants maintained virologic suppression at last known viral load at Month 24 or at discontinuation.

In Europe, the COMBINE-2 study, evaluating real-world outcomes for 956 virologically suppressed people with HIV initiating CAB+RPV LA across seven European countries, reported 99% virologic suppression at last measured viral load (median follow-up of 10.2 months), with low rates of confirmed virologic failure (0.5%) and high persistence (92% remaining on therapy).5

Real-world evidence focussed on the effectiveness of CAB+RPV LA outside the labelled indication in viraemic patients: The large-scale OPERA study further explored the effectiveness of CAB+RPV LA in treatment-experienced individuals initiating therapy with detectable viral loads and long-standing HIV. Among the 3,304 participants, 11% (368 individuals) initiated with baseline viremia (>50 copies/mL), of these, 88% achieved viral suppression to <50 copies/mL (of n=277/313 with ≥1 viral load during follow-up and VL <50 copies/mL at any point during follow-up). A separate analysis also showed that among a diverse group of 105 women initiating CAB+RPV LA with viremia, most achieved viral suppression (of 92 women with ≥1 VL at follow-up, 92% achieved VL <50 copies/mL at any point during follow-up), with confirmed virologic failure being rare.6,7

Through these findings, CAB+RPV LA was shown to address challenges associated with daily oral pills, offering improved treatment satisfaction, high effectiveness and a patient-preferred treatment option that supports long-term virologic control.

Implementation studies highlight CAB LA for PrEP is highly preferred and easy to implement for key prevention groups: The PILLAR and EBONI studies highlight the high acceptability and feasibility of CAB LA for PrEP for HIV prevention in broad populations, including men who have sex with men (MSM), transgender men (TGM), and Black women (BW).8,9

PILLAR is a phase IV implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the US among a broad population of MSM and TGM (n=201).8 CAB LA for PrEP was rated highly acceptable (mean 4.6/5 at Month 12) and feasible (mean 4.4/5), with 95% of participants (n=131) who switched from oral PrEP reporting being happy with the choice and 98% recommending CAB LA for PrEP (n=140). Flexible scheduling, reminders, and educational tools supported adherence, while stigma concerns were significantly lower compared to oral PrEP users.

Similarly, EBONI, an implementation study evaluating CAB LA for PrEP in Black cis and transgender women, among women’s health clinics, across 72 healthcare provider respondents at 15 clinics primary care and infectious disease clinics in the US. Data found CAB LA for PrEP highly appropriate (mean 4.5/5) and feasible (mean 4.4/5) for Black women.9 In addition, clinic capacity to accommodate CAB LA for PrEP tripled within a year without increasing staff or time commitment. The health benefits of two monthly visits included additional opportunities to screen for STIs, screening for comorbidities or providing other health or psychological care.

These findings highlight Apretude’s potential to support broader PrEP implementation and improve outcomes in underserved populations who may benefit the most across varied clinical settings.

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

About Vocabria (cabotegravir)

Vocabria injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class.

Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:

  • oral lead-in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.
  • oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.

Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant (rilpivirine) tablets should also be consulted for recommended dosing.

Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets

About Rekambys (rilpivirine)

Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35 kg) who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class.

Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection).

Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection

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

Post-Injection Reactions:

  • 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://gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/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.

CONTRADICTIONS

  • 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: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/DOVATO/pdf/DOVATO-PI-PIL.PDF

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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.

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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 Q1 Results for 2025.

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References:

  1. F. Felizarta, et al. The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in treatment naive people living with HIV. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
  2. F. Felizarta, et al. Perspectives of people living with HIV (PWH) 24 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.
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