Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV

This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.

Start Date15 Dec 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

[+1]

NCT05652478

/ RecruitingPhase 2IIT

A Phase 2 Randomized Cross-Over Design Study of the Early Metabolic Effects of Dolutegravir or Tenofovir Alafenamide in Healthy Volunteers

Background:
People with HIV take drugs to keep the amount of virus in their body low. One type of these drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time. Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to understand how INSTIs cause weight changes.
Objective:
To see how a common INSTI, dolutegravir (DTG), affects how the body uses energy. DTG will be compared with a non-INSTI drug, tenofovir alafenamide (TAF).
Eligibility:
Healthy people aged 18 to 55.
Design:
Participants will be screened. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function.
Participants will have 2 inpatient stays at the clinic. Each stay will be for 11 nights, with a 3-week break between.
Both DTG and TAF are gel caps swallowed once per day by mouth. Participants will take 1 drug for 8 days during each stay.
Participants will have tests to see how their body uses energy:
They will spend 23 continuous hours in a special room that measures how much oxygen they breathe in and how much carbon dioxide they breathe out. They will do this a total of 6 times.
They will have a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density.
They will lie on a table. Electrodes will be placed on their hands and feet to measure body fat and lean body mass.
They will stand still on a platform for about 30 seconds. High-resolution laser cameras will scan their bodies.

Start Date29 Sep 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

CTR20253373

/ RecruitingNot Applicable

多替拉韦钠片在健康受试者中的生物等效性试验

[Translation] Bioequivalence study of dolutegravir sodium tablets in healthy volunteers

本研究以成都倍特药业股份有限公司生产的多替拉韦钠片（50mg（以多替拉韦计））为受试制剂，以原研ViiV Healthcare B.V.持证，Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)生产的多替拉韦钠片（50mg（以多替拉韦计））（商品名：特威凯®）为参比制剂，评价受试制剂和参比制剂在空腹和餐后条件下给药时的生物等效性。观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

This study used dolutegravir sodium tablets (50 mg, calculated as dolutegravir) produced by Chengdu Beite Pharmaceutical Co., Ltd. as the test formulation and dolutegravir sodium tablets (50 mg, calculated as dolutegravir), licensed by the original ViiV Healthcare B.V. and produced by Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) (trade name: Tivicai®), as the reference formulation. The bioequivalence of the test and reference formulations was evaluated when administered on a fasting or fed basis. The safety of the test and reference formulations was observed in healthy volunteers.

Start Date12 Sep 2025

Sponsor / Collaborator

Brilliant Pharmaceutical Co. Ltd.

100 Clinical Results associated with Dolutegravir Sodium

100 Translational Medicine associated with Dolutegravir Sodium

100 Patents (Medical) associated with Dolutegravir Sodium

3,463

Literatures (Medical) associated with Dolutegravir Sodium

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Treatment persistence among treatment-experienced people with HIV switching to integrase strand transfer inhibitor–based antiretroviral regimens

Article

Author: Chen, Megan ; de Boer, Melanie ; Trom, Cassidy ; Chuo, Ching-Yi ; Christoph, Mary J. ; Zachry, Woodie

AIMS:

Low rates of persistence are associated with poor outcomes in people with HIV (PWH). This retrospective cohort study assessed treatment persistence as measured by time to treatment switch in treatment-experienced (TE) PWH initiating integrase strand transfer inhibitor (INSTI)-based regimens.

METHODS:

United States prescription claims and medical history data from the IQVIA Longitudinal Access and Adjudication Dataset between January 1, 2018, and August 31, 2023, were analyzed. TE PWH with ≥1 prescription claim for initiation of an INSTI-based antiretroviral regimen during the index period (January 1, 2020, to December 31, 2022) were included. Descriptive analyses of demographic and comorbidity variables were performed, stratified by regimen. Kaplan-Meier analysis was used to evaluate time to subsequent treatment switch in the overall population and among PWH aged ≥50 years, those receiving Medicare, and those with mental health conditions or substance use disorders.

RESULTS:

Overall, 29,348 TE PWH were included. The majority of INSTI-based regimen initiations were for bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (61%; n = 17,917), followed by dolutegravir/lamivudine (27.4%; n = 8034) and cabotegravir + rilpivirine (7.4%; n = 2186). A subsequent switch occurred in 3341 (11.4%) PWH. Risk factors for switch included female sex, Medicare/Medicaid coverage, and higher Charlson Comorbidity Index scores. B/F/TAF was associated with the fewest subsequent switches (9.2%; n = 1656) and was significantly less likely than any other regimen to lead to a subsequent switch, either in the overall population or in the three at-risk subgroups.

LIMITATIONS:

No data are available to determine the underlying reasons for initial treatment choice or subsequent treatment switch.

CONCLUSIONS:

This study provides evidence for greater treatment persistence with B/F/TAF versus other INSTI-based regimens. Unlike prior studies that focused on treatment-naïve individuals, this analysis uniquely evaluates persistence among treatment-experienced PWH initiating newer INSTI-based regimens.

31 Dec 2025·Global Health Action

Low-level viremia in people with HIV in Ethiopia is associated with subsequent lack of viral suppression and attrition from care

Article

Author: Abdissa, Alemseged ; Björkman, Per ; Abdulahi, Ilili Jemal ; Reepalu, Anton ; Elvstam, Olof ; Medstrand, Patrik

BACKGROUND:

Low-level viremia during antiretroviral therapy (ART) has been associated with inferior outcomes, but knowledge on the impact of low-level viremia in the current era of dolutegravir-based ART in low-income countries is limited.

OBJECTIVE:

To investigate whether low-level viremia predicts virologic non-suppression and attrition from care in people with HIV receiving ART in Ethiopia.

METHODS:

We included people receiving ART at public health facilities in an urban area in central Ethiopia and categorized persons with ≥1 available viral load 2019-2020 as having either suppression (<150 copies/mL) or low-level viremia (151-1,000 copies/mL); people with >1,000 copies/mL were excluded. We used multivariable logistic regression adjusted for age, sex, ART regimen, type of health facility, and duration of ART to analyze the associations between viremia category and incidence of unsuppressed viral load (>1,000 copies/mL) and attrition from care (death or loss to follow-up) during 3 years of follow-up.

RESULTS:

Among 12,165 participants, the median age was 44 years, 64.2% were female, and 89.1% received tenofovir/lamivudine/dolutegravir. Of the study population, 11,959 (98.3%) had suppression and 206 (1.7%) had low-level viremia. Over 3 years of follow-up, 2.2% of participants with suppression and 11.3% with low-level viremia had unsuppressed viral load. Low-level viremia was associated with both unsuppressed viremia (adjusted odds ratio [aOR], 3.7; 95% confidence interval [CI], 2.2-6.2) and attrition (aOR, 3.4; 95% CI, 1.7-6.6).

CONCLUSION:

Among Ethiopian people with HIV receiving ART, low-level viremia predicted subsequent virologic non-suppression and attrition from care, supporting current recommendations for heightened attention to low-level viremia in ART recipients.

31 Dec 2025·ANNALS OF MEDICINE

24-month outcomes after switching to Dolutegravir/Lamivudine in people living with HIV and HBcAb positivity at the Beijing Ditan Hospital in China

Article

Author: Zhao, Hongxin ; Liu, Ying ; Biao, Ruojia ; Chen, Jing ; Fu, Jiantao

BACKGROUND:

Dolutegravir/lamivudine (DTG/3TC) is a recommended therapy regimen for hepatitis B surface antigen (HBsAg)-negative people living with HIV (PLWH) who have achieved HIV virological suppression or are treatment-naïve. However, this may overlook the impact of occult hepatitis B infection on HIV suppression, which mainly present as hepatitis B core antibody (HBcAb) positive but HBsAg negative. We aim to assess the effect of HBcAb positivity on HIV suppression among PLWH who had switched to DTG/3TC.

METHODS:

A retrospective study was conducted including 127 HBcAb-positive and 474 HBcAb-negative PLWH (all were HBsAg negative) who had switched to DTG/3TC at the Beijing Ditan Hospital in China. HIV-RNA suppression was compared pre-switch (not baseline), at switch, and at 12&24 months post-switch, across three categories: (1) target not detected (TND); (2) HIV RNA < 40 cp/mL; (3) blip. Virological suppression included TND and HIV RNA < 40 cp/mL. Epidemiological (gender, age) and clinical data (CD4 count, HIV viral load, etc.) were extracted from the hospital information system. A p-value < 0.05 was considered statistically significant.

RESULT:

HBcAb-positive PLWH were older at DTG/3TC switch (median age: 41 vs. 36 years old, p < 0.001) and had lower nadir CD4 counts (median nadir CD4 counts: 255 vs. 295, p = 0.011). No difference in TND and HIV RNA < 40 cp/mL was present in the two groups at the switch (HBcAb-positive and -negative: 86.6% vs. 88.8%, 12.6% vs. 10.5%, p = 0.789). Similar HBcAb-positive compared with -negative PLWH resulted in TND at 12&24 months post-switch: 91.4% vs. 91% (p = 0.522) and 88.4% vs. 92.7% (p = 0.249), respectively. Consistent result was observed in HIV RNA < 40 cp/mL.

CONCLUSION:

In the 24-month follow-up after switching to DTG/3TC, HBcAb positivity was not significantly associated with HIV virological suppression.

147

News (Medical) associated with Dolutegravir Sodium

16 Sep 2025

·endpoints.news

Exclusive: Fred Hutch duo's startup launches with $10M to build AI generative genomics models

If scientists run enough variations of a lab experiment, perhaps AI models could, someday, predict the results of future versions of that study. A new Seattle-based startup called Synthesize Bio believes it may be able to achieve that sooner than later, starting with gene-expression studies. Synthesize has already generated some promising results in predicting these types of lab experiments, according to a preprint published Tuesday. Synthesize will officially launch on Wednesday, its co-CEOs , Jeff Leek and Robert Bradley, exclusively told Endpoints News, as it releases its AI model, called GEM-1. The 15-employee biotech was founded in 2023 and raised a previously undisclosed $10 million seed round in October 2023, led by Madrona Ventures. Other investors include Sahsen Ventures, AI2 Incubator, Inner Loop Capital, and MD Venture Investments. Leek and Bradley came up with the idea behind Synthesize in the hallways of the Fred Hutchinson Cancer Center. Leek is the cancer center’s chief data officer, and Bradley is the scientific director of a translational data science research center. They wanted to see if biotech could follow a similar trajectory in building large AI models, similar to how companies like OpenAI and Anthropic grew large language models trained on nearly all of the internet’s data. “We felt like this is an idea where we believe it can transform how scientists go about their work,” Bradley said in an interview. The Fred Hutch duo built a model called GEM-1 over the last two years. The model is trained on tons of different gene-expression experiments that they curated and annotated from public datasets. Synthesize is already at work on the next-generation version of the model called GEM-2. “This is the worst version of the GEM model you will ever see,” Leek said. “It’s only going to get better over time.” Gene-expression experiments and single-cell studies have been a hot space within the AI bio field. Large organizations, like the Chan Zuckerberg Initiative and the Arc Institute , are championing moonshot projects that view these types of experiments as key building blocks in eventually making models of virtual cells. Virtual cells could allow more experiments traditionally done in the lab to be accurately simulated by computers. Other startups, like Noetik , Tahoe Therapeutics , and Xaira Therapeutics , are also taking their own twists on building large or rich datasets using some of these experiments. Synthesize believes its model can tackle a wider range of gene-expression experiments than the rest. To test that belief, they looked at how GEM-1’s predictions compared to real-world results. They set a cut-off date of mid-2024, training their model on experimental data in public databases before that date, and then using new experiments added after that date as tests. Overall, Synthesize’s team found GEM-1 “yielded accuracy comparable to the best-possible performance estimated by comparing the results of matched lab experiments,” according to the preprint. The preprint also found that about 95% of these new experiments were similar to those in GEM-1’s training data, meaning the model had already seen experiments that studied similar types of cells or similar perturbations. GEM-1’s predictions varied in accuracy. The model nailed the effect on gene expression of certain molecules, like the hair-loss drug finasteride and an alpha blocker called doxazosin. But predictions for other compounds were less than 50% accurate, like the HIV treatment dolutegravir or cancer drug afatinib, according to the preprint. An area of active research is working on confidence intervals, which could give users a sense of the quality of a prediction. Bradley said that’s something the broader AI field is also working on, as it’s an important problem. That could be critical in telling the finasteride and afatinib predictions apart. “Our goal is not to replace experiments,” Bradley said. “Our goal is to have a seamless blend of wet-lab work and AI experimentation. Experiments are critical. They’re always going to be the gold standard.” Instead, GEM-1 could allow scientists on finite budgets to consider more data for experiments they may not have the time or resources to run. It could also enable scientists to get a sense of results on experiments that are impossible or impractical today, Bradley said. For instance, the model could help predict a drug’s activity in tissue where you can’t take a patient’s biopsy, he said. Leek said there are blind spots, where GEM-1’s performance is wanting. That’s why they are eager to release the model openly, including free access on its website , to gain a sense of how researchers use it and its real-world performance.

24 Jul 2025

·www.shionogi.com

ViiV Healthcare’s Presentation on the VOLITION Study of Long-Acting Injectable Cabenuva in HIV Treatment

• 89% of people living with HIV expressed a preference to switch from daily oral therapy to long-acting injectable Cabenuva OSAKA, Japan, July 24, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that ViiV Healthcare Ltd. (“ViiV”), in which Shionogi holds equity alongside GlaxoSmithKline plc and Pfizer Inc., has presented results from the Phase IIIb VOLITION study of Cabenuva at the 13th International AIDS Society Conference (IAS 2025). The VOLITION study was conducted in treatment-naïve adults living with HIV. Following rapid viral suppression with daily oral Dovato (dolutegravir and lamivudine), participants were offered the choice to either continue with Dovato or switch to the long-acting injectable Cabenuva (cabotegravir and rilpivirine). Results showed that 89% (n=129/145) of participants chose to switch to Cabenuva. The most commonly cited reasons were “Not having to worry about missing a dose each day” (80%) and “Not having to carry medication” (68%). These findings highlight the potential of long-acting regimens to improve adherence and overall treatment satisfaction among people living with HIV. Shionogi has positioned “Protect people from the threat of infectious diseases” as one of its key material issues and is committed to addressing the three major infectious diseases—HIV, tuberculosis, and malaria—through comprehensive initiatives. With over 60 years of experience in infectious disease research and development, Shionogi will continue to work in partnership with ViiV Healthcare to contribute to global health by advancing both treatment and prevention strategies for HIV. Reference: About Dovato (marketed in Japan as Dovato Combination Tablets) Dovato is a daily oral two-drug regimens containing dolutegravir 50 mg and lamivudine 300 mg. It is approved for the treatment of HIV-1 infection in adults who are either treatment-naïve or virologically suppressed on antiretroviral therapy, with no known resistance to dolutegravir or lamivudine. About Cabenuva (marketed in Japan as Vocabria Intramuscular Suspension and Rekambys® Intramuscular Suspension) Cabenuva is the world’s first long-acting injectable for HIV treatment. It is approved in major markets including Japan, the U.S., Europe, and China as a treatment option administered once every two months.1 In addition to the results of this study, multiple real-world data led by ViiV Healthcare—including COMBINE-2, CARLOS, BEYOND, and OPERA—have demonstrated high efficacy, tolerability, and improved adherence, contributing to enhanced treatment satisfaction across a broad range of patient populations.2 1. ViiV Healthcare Press Release: February 26, 2024 LATITUDE PHASE III INTERIM TRIAL DATA INDICATES ViiV HEALTHCARE’S LONG-ACTING INJECTABLE HIV TREATMENT CABENUVA (CABOTEGRAVIR + RILPIVIRINE) HAS SUPERIOR EFFICACY COMPARED TO DAILY THERAPY IN INDIVIDUALS LIVING WITH HIV WHO HAVE ADHERENCE CHALLENGES 2. ViiV Healthcare Press Release: July 14, 2025 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 Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

Phase 3Clinical ResultDrug Approval

14 Jul 2025

·www.businesswire.com

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

LONDON--(BUSINESS WIRE)--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 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 U.S. 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 U.S. 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. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About Apretude (cabotegravir long-acting for PrEP) Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. 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. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir. Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection 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 35kg) 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 35kg) 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 35kg) 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 About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the US and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information here. About Dovato (dolutegravir and lamivudine) Dovato is indicated as a complete regimen to treat HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40kg, in the EU, and weighing at least 25kg in the US, with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato. Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets. 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 gsk.com. 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 Q1 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 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. 3 G. Blick, et al. Clinical outcomes at month 24 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 4 C. Wyen, et al. 24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real‑world setting: effectiveness, adherence to injections, and participant-reported outcomes from people with HIV-1 in the German CARLOS cohort. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 5 A. Pozniak, et al. High virologic suppression and few virologic failures with Long-Acting Cabotegravir + Rilpivirine in Treatment Experienced Virologically Suppressed Individuals from COMBINE-2 cohort in Europe. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 6 R. Hsu, et al. Real-world effectiveness of CAB+RPV LA in individuals with HIV viremia at therapy initiation. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 7 J. Altamirano, et al. Clinical outcomes among women in the OPERA cohort initiating CAB+RPV LA with viral loads ≥ 50 copies/mL. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 8D. Dandachi, et al. One-year implementation outcomes of cabotegravir long-acting injectable PrEP in men who have sex with men (MSM) & transgender men (TGM): findings from the PILLAR study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 9 Z. Tims-Cook, et al. Health care provider experiences after 12 months of implementing cabotegravir long-acting injectable PrEP (CAB LA) for Black women: EBONI study results. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Dolutegravir Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D10113	Dolutegravir Sodium	J05AX12	DB08930

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HIV Infections	United States	ViiV Healthcare Co.	12 Aug 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Tuberculosis	Phase 3	Brazil	ViiV Healthcare Ltd.	18 Sep 2025
Tuberculosis	Phase 3	Brazil	ViiV Healthcare Ltd.	18 Sep 2025
Pregnancy	Phase 3	South Africa	ViiV Healthcare Ltd.	14 Mar 2017
Pregnancy	Phase 3	Uganda	ViiV Healthcare Ltd.	14 Mar 2017
Latent Tuberculosis	Phase 2	United States	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	Botswana	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	Haiti	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	Malawi	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	South Africa	ViiV Healthcare Ltd.	27 Feb 2021
Latent Tuberculosis	Phase 2	Thailand	ViiV Healthcare Ltd.	27 Feb 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


GS-US-380-1844，ALLIANCE (Pubmed)	-	HIV Infections	2,622	多替拉韦+恩曲他滨+丙酚替诺福韦	uyrzczxwdh(wwijruhbcl) = wwmkkgvqli aecipovkkz (ewnvvgdwjm ) View more	Positive	18 Nov 2024
				多替拉韦	uyrzczxwdh(wwijruhbcl) = teiezwnqpg aecipovkkz (ewnvvgdwjm ) View more
NCT03048422 (IMPAACT 2010 (VESTED), Pubmed \| J Acquir Immune Defic Syndr)	Phase 3	bone mineral density \| creatinine clearance	-	Dolutegravir + emtricitabine/tenofovir alafenamide (DTG + FTC/TAF)	efteotoxtp(ywayehwwjo) = hhihhfqahe mlqjgahcmr (zlsgicicon )	Positive	01 Oct 2024
				Dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + FTC/TDF)	efteotoxtp(ywayehwwjo) = ppgmjfifch mlqjgahcmr (zlsgicicon )
NCT03017872 (D2EFT, Pubmed)	Phase 4	HIV Infections Second line HIV RNA load	828	ritonavir-boosted darunavir plus two NRTIs	pickgpztxf(wrlzaflknw) = kufrznnifm qdtwwkwbya (izpwpypomp )	Positive	01 Jul 2024
				ritonavir-boosted darunavir plus dolutegravir	pickgpztxf(wrlzaflknw) = qzvxqaecwk qdtwwkwbya (izpwpypomp )
NCT04857892 (CTgov)	Phase 1	HIV Infections	41	GSK3640254+DTG (Part 1:Treatment A:GSK3640254 25mg+GSK3640254 100mg+DTG 50 mg)	weradlerqf(uwjwcixwcv) = igywrmmixa zdongqehdf (trqzwhwmrp, 46.8) View more	-	12 Mar 2024
				GSK3640254+DTG (Part 1:Treatment B:GSK3640254/DTG 150/50 mg(Monolayer Tablet))	weradlerqf(uwjwcixwcv) = psfgbruvxw zdongqehdf (trqzwhwmrp, 36.6) View more
NCT01837277 (IDEA, CTgov)	Phase 2/3	Acquired Immunodeficiency Syndrome	186	Dolutegravir 50 mg (Dolutegravir)	matvxskvsj = sbrfkpvgas yijlhhiarb (jvvvmcwzcj, rcmscpjvik - bhyexxvksk) View more	-	14 Dec 2023
				Efavirenz (Efavirenz)	matvxskvsj = lrddgkyawp yijlhhiarb (jvvvmcwzcj, xbhmdantuv - tsbubrylsz) View more
NCT02777229 (NAMSAL-ANRS-12313, Pubmed \| Open Forum Infect Dis)	Phase 3	HIV Infections First line	613	Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)	jxmtealewz(xwkymrycuz) = uuqwruyxwz yjofhycodm (fcbikmtvku ) View more	Positive	01 Dec 2023
				Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)	jxmtealewz(xwkymrycuz) = xihxgqfqkq yjofhycodm (fcbikmtvku ) View more
NCT02777229 (NAMSAL ANRS 12313, Pubmed)	Phase 3	First line	613	Dolutegravir 50 mg (DTG)	hdygegcyvo(bigxjgmsec) = decreased from 7.2 to 3.0 xpuotfnfrf (odlouwotbs ) View more	Positive	01 Nov 2023
				Low-dose efavirenz (EFV400)
NCT02777229 (NAMSAL ANRS 12313, Pubmed \| J Acquir Immune Defic Syndr)	Phase 3	HIV Infections First line	613	Dolutegravir 50 mg (DTG)	lycagljqyq(oxkftbxtph) = frxjhsgbtm foafhwrgzn (zseqrjmide ) View more	Positive	01 Nov 2023
				Low-dose Efavirenz (EFV400)	lycagljqyq(oxkftbxtph) = uttgqfqjct foafhwrgzn (zseqrjmide ) View more
NCT03851588 (RADIANT-TB, CTgov)	Phase 2	Tuberculosis \| HIV Infections	108	Dolutegravir 50 mg (Supplementary Dose)	lavzhholzp = xqvgvuwzyy isagecrldj (pwpghlfnrd, vybrswduci - abdckxoacj) View more	-	18 Sep 2023
				Placebo (Placebo Dose)	lavzhholzp = dvrbtojgnr isagecrldj (pwpghlfnrd, dpufmifvol - wyhopgsyqv) View more
NCT03224338 (Phase 2 Study, Pubmed \| Clin Infect Dis)	Phase 2	HIV Infections First line	30	Dolutegravir plus 2 NRTIs	ujtinqjvly(iuftzckpxf) = One participant discontinued due to central nervous system symptoms rispgadgky (wgwapnmzsn ) View more	Positive	11 Sep 2023

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis