Triumeq is an approved medicine for HIV. The effectiveness of Triumeq in Amyotrophic Lateral Sclerosis (ALS) is being investigated in the Lighthouse II trial. This study aims to assess whether Triumeq is safe and effective at delaying ALS disease progression when given long term. It is available for participants who have completed the Lighthouse II study. The main measurements are safety, tolerability and survival.
The study will go for approximately 2 years.

Start Date15 Nov 2024

Sponsor / Collaborator

Macquarie University

NCT05393193

/ Active, not recruitingPhase 4IIT

Point-of-Care HIV Testing and Early Dolutegravir Use for Infants

This study is being conducted to explore the feasibility of implementing targeted birth HIV testing of high-risk neonates using facility-based point-of-care (POC) HIV diagnostics, and to improve the ability to implement the best standard-of-care treatment possible. Infants found to be HIV infected will be immediately offered enrollment into a dolutegravir (DTG) antiretroviral treatment study cohort (if maternal consent is granted) or referred for treatment at a government facility. Infants who enter the study treatment cohort will be prospectively followed through 96 weeks of age. ART will follow Botswana guidelines.

Start Date04 Jul 2022

Sponsor / Collaborator

Harvard T.H. Chan School of Public Health

[+2]

CTRI/2022/02/040130

/ Not yet recruitingPhase 1

An open label, balanced, randomized, two-treatment, two-sequence, two-period, cross-over, single-dose, oral bioequivalence study of Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60mg/5mg/30mg (1 Ã? 5 Tablets) (Test) of Aurobindo Pharma Limited, India with Dolutegravir (GSK1349572)/Abacavir/Lamivudine Dispersible Tablets 5 mg/60 mg/30 mg (1 Ã? 5 Tablets) (Reference) of ViiV Healthcare, UK in 54 healthy, adult, male subjects under fasting conditions

Start Date14 Feb 2022

Sponsor / Collaborator

AXIS Clinicals Ltd.

100 Clinical Results associated with Abacavir sulfate/Dolutegravir sodium/Lamivudine

100 Translational Medicine associated with Abacavir sulfate/Dolutegravir sodium/Lamivudine

100 Patents (Medical) associated with Abacavir sulfate/Dolutegravir sodium/Lamivudine

Literatures (Medical) associated with Abacavir sulfate/Dolutegravir sodium/Lamivudine

31 Dec 2026·ASN Neuro

Exposure to Frontline Antiretroviral Dolutegravir Disrupts Oligodendrocyte Development Across Differentiation Stages

Article

Author: Cruz-Berríos, Melanie ; Grinspan, Judith B. ; Putatunda, Raj ; Romer, Micah A. ; Jeffries, Marisa A. ; Jordan-Sciutto, Kelly L. ; Singhal, Anushka

The use of antiretroviral (ART) treatment during pregnancy has dramatically reduced rates of perinatally-acquired human immunodeficiency virus 1 (HIV-1) infection to <1% in the United States. Despite this success, we have limited knowledge of how ART drugs that cross the placental barrier affect fetal development, particularly in the central nervous system (CNS). During gestation, large populations of oligodendroglia are produced that are responsible for critical postnatal CNS myelination enabling appropriate neurological function. Previous studies have shown that antiretrovirals impair oligodendrocyte (OL) differentiation leading us to hypothesize that OL maturation might be inhibited by exposure to a frontline ART drug cocktail (Triumeq®) prescribed during pregnancy containing dolutegravir (DTG), abacavir (ABC), and lamivudine (3TC). In this study, we demonstrated that exposing primary rat oligodendrocyte precursor cells (OPCs) and OLs to the Triumeq drug combination decreased OL maturation and myelin protein production in a concentration-dependent manner, and that DTG was solely responsible. Regardless of the timing of exposure during OL development, a high concentration of DTG inhibited OL maturation. Bulk RNA sequencing revealed transcriptional changes after DTG exposure related to a variety of cellular mechanisms, including cellular responses to stress pathways, amino acid starvation, and mitochondrial dysfunction. Although we found that DTG robustly activated the integrated stress response (ISR), attempted rescue experiments showed that DTG primarily inhibits OL maturation independently of the ISR. Collectively, our novel data on DTG underscore the necessity of investigating how ART drugs that are administered during pregnancy and cross the placental barrier can affect fetal CNS development.

01 Jun 2026·ADVANCES IN THERAPY

Safety and Effectiveness Analysis of Dolutegravir and Dolutegravir/Abacavir/Lamivudine in Japanese People Living with HIV: 10 years of Post-Marketing Surveillance

Article

Author: Matsukawa, Tomoko ; Wang, Dong ; Suzuki, Miwako ; Nagao, Takako ; Fukuda, Akiko ; Yoshikawa, Yoichiro ; Maeno, Yuko ; Ibe, Shiro ; Sebata, Akemi

INTRODUCTION:

Dolutegravir (DTG), an integrase strand transfer inhibitor, is recommended as a first-line antiretroviral therapy (ART) for HIV/AIDS in international guidelines. In Japan, approved DTG-containing formulations include the single-agent DTG (Tivicay® tablets) and the fixed-dose combination of DTG, abacavir sulfate, and lamivudine (DTG/ABC/3TC, Triumeq® combination tablets). Although overseas clinical trials have demonstrated the favorable safety and effectiveness of these DTG-containing products, evidence specific to Japanese people living with HIV/AIDS (PLHIV) has remained limited. This report presents the final findings from a decade-long, prospective, post-marketing surveillance of single-agent DTG and DTG/ABC/3TC initiated in 2014.

METHODS:

Data on the real-world clinical use of the single-agent DTG and DTG/ABC/3TC were obtained through the HIV-Related Drug Cooperative Survey, a national joint post-marketing program overseen by Japanese manufacturers of HIV therapies. Adverse drug reactions (ADRs) were captured and classified using the Medical Dictionary for Regulatory Activities. Associations between ADR incidence and potential risk factors were examined. Effectiveness was evaluated by longitudinal changes in plasma HIV RNA copy number and peripheral CD4⁺ cell counts.

RESULTS:

Among 2345 PLHIV included in the safety analysis, 652 patients (27.80%) reported ADRs. The most frequently reported ADRs were increased blood creatinine (4.78%), abnormal hepatic function (2.43%), and nausea (2.30%). ADR incidence was higher in participants with baseline comorbidities, those receiving concomitant medications, and ART-naïve participants, relative to their counterparts. Notably, no progressive increase in ADR incidence was observed during prolonged use > 2 years. Plasma HIV RNA levels demonstrated sustained improvements from baseline in both ART-naïve and ART-experienced participants. By 12 months after administration, the proportion of participants achieving plasma HIV RNA levels < 50 copies/ml was about 90% in ART-naïve participants and about 96% in ART-experienced participants. Additionally, CD4⁺ T cell counts also demonstrated sustained improvement from baseline in both ART-naïve and ART-experienced participants.

CONCLUSION:

This 10-year post-marketing surveillance confirms the long-term safety and effectiveness of single-agent DTG and DTG/ABC/3TC in Japanese PLHIV. No new safety concerns emerged over the 10-year surveillance period, further supporting their established safety profiles and reinforcing their continued role as key therapeutic options in routine clinical practice.

01 Jan 2025·JOURNAL OF CLINICAL PHARMACOLOGY

A Model‐Based Approach Supporting Abacavir/Dolutegravir/Lamivudine Fixed‐Dose Combination Approval in Children Living with HIV‐1

Article

Author: Tan, Lionel K. ; Hyatt, Stephen ; Brothers, Cindy ; Goyal, Navin ; Buchanan, Ann M. ; Adkison, Kimberly ; Chandasana, Hardik ; McKenna, Michael

Abstract:

In March 2022, the US Food and Drug Administration expanded indications of TRIUMEQ, a once‐daily fixed‐dose combination (FDC) containing abacavir (ABC), dolutegravir (DTG), and lamivudine (3TC) to include pediatric patients weighing at least 10 kg for the treatment of HIV‐1. Prior to this extension, the ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablet was approved for use only in the adult/adolescent population, weighing ≥40 kg while each component of the FDC was approved for its use in pediatric patients at least 3 months and older. A new child‐friendly formulation was developed as an FDC dispersible tablet (DT) of ABC 60 mg/DTG 5 mg/3TC 30 mg for pediatric patients with a body weight ≥ 6 kg. The present work demonstrates the utility of applying a model‐informed drug development (MIDD) approach to expedite ABC/DTG/3TC FDC approval for pediatric patients (≥10 to <40 kg) based on data from the existing individual components and formulation bridging. Population pharmacokinetic models developed for pediatric participants across all three components of ABC/DTG/3TC FDC were employed for exposure prediction and incorporated relative bioavailability data. The predicted plasma exposures of ABC, DTG, and 3TC for FDC doses were consistent with those observed for the single entities in pediatric and adult studies. Thus, safety and efficacy observed in the individual component studies could be adequately extrapolated to the FDC that results in similar exposure. The current work demonstrates the significance of MIDD approaches in facilitating expedited access to child‐friendly formulations in the HIV‐1 therapeutic area.

News (Medical) associated with Abacavir sulfate/Dolutegravir sodium/Lamivudine

28 Jul 2026

·www.fiercepharma.com

GSK CEO targets $2.5B in cost savings from mature products, procurement, supply chain

About half a year into his tenure as GSK’s CEO, Luke Miels is launching a three-year restructuring to navigate the British pharma through upcoming patent cliffs and achieve over 40 billion pounds sterling in annual sales by 2031. The three-year initiative is designed to generate 1.9 billion pound sterling ($2.5 billion) in annual cost savings by 2029, against 2.4 billion pound sterling in total one-time costs. The cost reductions will mainly be pulled from three levers, CEO Luke Miels explained during a media briefing Tuesday. About 45% of the savings will target simpler processes and better procurement across different systems, consultation services and other partners support functions, the CEO said. Another 40% of the major restructuring is focused on “reallocating resources from our mature portfolio of our mature products to our specialty, novel products,” the CEO said, pointing to how a product targeting general practitioners requires a large commercial field force. The remaining 15% of the cuts will fall on the supply chain. The chief executive declined to provide the number of jobs being affected because “I want my team to have the chance to discuss this with our people first.” The program is the result of an enterprise-wide review of GSK’s cost base looking for ways to improve operations, GSK’s CFO, Julie Brown, said on Tuesday’s media call. Brown highlighted AI as a tool that GSK is leveraging to streamline processes across the organization and speed up operations. A small amount of the savings will go to improving operating margins to offset the impact from the upcoming loss of exclusivity for blockbuster HIV drug dolutegravir—used in such drugs as Tivicay, Triumeq and Dovato—between 2028 to 2030. Nevertheless, Miels stressed that the overhaul is about “reinvesting these savings into the late-stage pipeline, so that we can set the company up for success for the next decade.” The British pharma on Tuesday also unveiled a plan to initiate 20 phase 3 clinical trials by the end of 2026, doubling the number that the company committed to earlier this year. Following a full portfolio review, GSK has identified opportunities to accelerated development across 18 indications and 25 studies for seven key assets in oncology, respiratory, hematology and vaccines, according to Miels. GSK unveiled the big savings program alongside 8.4 billion pound sterling ($11.1 billion) in sales for the second quarter, up 5% year over year and 2% ahead of analysts’ expectations. Revenues from specialty medicines of 3.8 billion pounds and vaccines of 2.3 billion pounds beat consensus by 3% and 9%, respectively, according to Jefferies. As a result of the strong performance, GSK now expects its top line to land at the top end of the 3%-to-5% range at the constant exchange rate. The company also dialed up its estimates for the vaccines department, now expecting sales there to be broadly stable and increase by a low single-digit percentage, versus previous expectations for a decline to broadly stable performance.

Financial StatementVaccine

04 Feb 2026

·www.pharmaceutical-technology.com

GSK oncology and HIV drugs leads to 7% sales rise in 2025

GSK will focus on commercial launches and R&D acceleration to drive its success into 2026 and beyond. Image credit: Magda Wygralak via ShutterStock.com. GSK has posted positive sales results for fiscal year 2025 (FY2025) as the company’s new CEO, Luke Miels, takes the helm. In 2025, GSK achieved constant exchange rate (CER)-adjusted total sales of £32.7bn ($44.8bn) – up 7% from the £31.4bn achieved in 2024. Meanwhile, GSK’s core earnings per share (EPS), which excludes one-time measures was £1.72 ($2.36). The company’s market cap is currently £83.91bn ($142.6bn). During FY2025, GSK saw notable growth across its oncology portfolio, with sales income across the disease area swelling by 43% to just under £2bn ($2.7bn) compared to 2024. This forward momentum was primarily driven by a strong 89% sales increase in the company’s programmed death-1 (PD-1) inhibitor Jemperli (dostarlimab), which pulled in £861m. Myelofibrosis therapy Ojjaara/Omjjara (momelotinib) also had a robust sales growth in 2025, bringing in 60% more than the corresponding 2024 revenues with £554m in global sales. GSK’ HIV portfolio was also a key contributor to the company’s growth in 2025 – with an 11% growth compared to 2024 through a total income of £7.7bn. The company’s combination tablet, Dovato (dolutegravir/lamivudine) continued to be GSK’s best-selling HIV drug in 2025, with sales growing 22% to £2.7bn. However, the long-acting injectable therapy, Cabenuva (cabotegravir/rilpivirine), eclipsed Dovato in terms of growth, pulling in 42% more than 2024 figures with a total sales value of £1.4bn. In an investor call on 4 February, the CEO of GSK-owned ViiV Healthcare, Deborah Waterhouse, noted that these results will help offset the upcoming patent expiry of Tivicay (dolutegravir) in October 2027. While GSK has seen an uptick in its HIV portfolio in 2025, Citi analysts expect that Gilead Sciences will continue to be the market leader due to the “breadth of long-acting treatment and pre-exposure prophylaxis (PrEP) therapies in development”. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Lupus medication Benlysta (belimumab) also had a good year in 2025, with sales up 22% to $1.8bn. Meanwhile, GSK’s vaccine portfolio posted modest gains of 2%, despite waning US sales of its influenza, shingles and meningitis vaccines prompted by the Trump administration’s continued efforts to influence vaccine policy. Overall, GSK’s shingles and meningitis portfolios achieved overall growth of 8% and 12% YoY, respectively – generating £3.6bn and £1.6bn each. GSK now expects 2026 turnover growth of 3–5%. GSK’s next steps As GSK looks to 2026 and beyond, new CEO Luke Miels hopes to guide the company to success through its pipeline, which it will look to achieve through the initiation of ten pivotal trials in 2026. This includes studies for two of the company’s antibody-drug conjugate (ADC) candidates – risvutatug rezetecan and mocertatug rezetecan – which will be evaluated across multiple tumour types. GSK is also expecting five pivotal trial readouts in 2026, one of which, bepirovirsen in chronic hepatitis B, has already shown success . The company will also explore ways to maximise the launch of next-wave products, while accelerating R&D in key assets and reducing its operational complexity. As GSK seeks growth between 2028 and 2030, the company is banking on the potential HIV medications – particularly in the treatment context – which Waterhouse believes present the “biggest opportunity” to GSK’s future presence in the HIV market. Success in its HIV pipeline will be vital for GSK as it is set to be hit by patent expiries between 2027 and 2030 for dolutegravir, the compound used in Triumeq, Tivicay, and Dovato. Core patents for dolutegravir are expiring in 2027 and 2028. Dolutegravir products brought in a total of $5.65bn for GSK in 2025.

VaccineFinancial StatementDrug Approval

24 Jan 2025

·pharma.economictimes.indiatimes.com

Biggies to face new contender in HIV as Lupin generics secures tentative approval from FDA

Mumbai: Generics drug maker Lupin Limited announced that it has received tentative approval from the FDA under the US President’s Emergency Plan for AIDS Relief for its Abacavir, Dolutegravir and Lamivudine tablets for oral suspension. Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen, indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg. This product would be manufactured at the company's Nagpur facility in India and will be supplied to low-and middle-income countries, the release stated. Ramesh Swaminathan, Executive Director, Global CFO & Head -API Plus SBU, Lupin said, “We are committed to providing affordable and high-quality treatments for patients worldwide. The tentative approval from the U.S. FDA for our Abacavir, Dolutegravir and Lamivudine Tablets enables us to improve the well-being of pediatric patients with HIV-1, thereby significantly boosting our HIV medication portfolio.” The generic version is equivalent to Triumeq PD Tablets for Oral Suspension, of ViiV Healthcare Company owned by GSK, with Pfizer and Shionogi as minority shareholders around 15 per cent and 5 per cent respectively. As of September 2024, Triumeq has an annual sales of $1.3 million in the US drug market and the novel drug had pediatric exclusivity till December 2026. By Online Bureau ,

Drug Approval

100 Deals associated with Abacavir sulfate/Dolutegravir sodium/Lamivudine

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KEGG	Wiki	ATC	Drug Bank
D10600	Abacavir sulfate/Dolutegravir sodium/Lamivudine	J05AR13	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	United States	ViiV Healthcare Co.	22 Aug 2014

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


IAS2023	Not Applicable	HIV Infections	2,934	BIC/FTC/TAF	scfgrytjfo(fbppquopgp) = rxeyxavmqv bwutknaqun (ogdnoophmj, 15.4 - 20.2) View more	Positive	23 Jul 2023
				E/C/F/TAF	scfgrytjfo(fbppquopgp) = hshjwjatdn bwutknaqun (ogdnoophmj, 21.3 - 31.6) View more
NCT04827134 (CTgov)	Phase 1	HIV Infections	33	TRIUMEQ+DTG+ABC+3TC (Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed)	evoszpomnh(eikotrtrde) = omfdneddzt ncicuimvmd (dygbgclcrs, 25.7) View more	-	05 Jun 2023
				DTG+ABC+3TC (Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted)	evoszpomnh(eikotrtrde) = yrjlfetpas ncicuimvmd (dygbgclcrs, 24.0) View more
NCT03760458 (CTgov)	Phase 1/2	Acquired Immunodeficiency Syndrome \| HIV Infections	57	Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets (Weight Band #1 (6 to Less Than 10 kg at Study Entry))	olcrsbuazl(xpvnbhxkpw) = jkrmaskajq hqiojrlgcl (nqvvhzebqz, 33.8) View more	-	13 Feb 2023
				Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets (Weight Band #2 (10 to Less Than 14 kg at Study Entry))	olcrsbuazl(xpvnbhxkpw) = xjgzphiqkq hqiojrlgcl (nqvvhzebqz, 50.6) View more
NCT02075593 (200336, CTgov)	Phase 3	HIV Infections	4	DTG+ABC+3TC (DTG/ABC/3TC - Mother)	sitjznuyhk(bwrqfvgvod) = kzlugtqdey fhmdeszvbr (xpmrkaqrlr, ujziawifdd - ifagxneaub) View more	-	18 Feb 2022
				DTG+ABC+3TC (DTG/ABC/3TC - Infant)	dtildunxub(oeuqytdozs) = ytnsjmllbx uwnsvzimzh (khwovcnkub, 1.71) View more
NCT02105987 (STRIIVING, Pubmed 1 \| Pubmed 2 \| Antivir Ther)	Phase 3	HIV Infections	553	Abacavir/Dolutegravir/Lamivudine	cbgqfceiiq(zizxmqhwlj) = eimomxgqgj chtriykzpa (jfriqkgnuy ) View more	Non-inferior	01 May 2017
				Current ART	cbgqfceiiq(zizxmqhwlj) = hozsmlxroy chtriykzpa (jfriqkgnuy ) View more
NCT01910402 (ARIA Study \| ARIA, CTgov)	Phase 3	HIV Infections	499	DTG+ABC+3TC (DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase)	nnitmsjfzi = xncslreqxc rxptnszrmp (tcetzbsezn, bgeyxmfklj - gygwknqmpm) View more	-	31 Oct 2016
				FTC+ATV+TDF+RTV (ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase)	nnitmsjfzi = jkzwpxcjmw rxptnszrmp (tcetzbsezn, hzecbxdjlk - nvnwnhhtac) View more
NCT02105987 (201147 \| STRIIVING, CTgov)	Phase 3	HIV Infections	555	DTG+ABC+3TC+FDC (ABC 600 mg / DTG 50 mg /3TC 300 mg FDC)	zdfbvxijjx = pbaipocewz znhagpkhig (kweatniazj, kygfkmkqyb - mkauzgcjid) View more	-	25 Feb 2016
				DTG+ABC+3TC (Current ART)	zdfbvxijjx = forqehvble znhagpkhig (kweatniazj, gbhsurefup - mxtabtsmml) View more
NCT01910402 (ARIA Study, IAS 12016 \| IAS 22016)	Phase 3	HIV Infections	495	DTG/ABC/3TC	wgugqnuscm(twuyccbxjg) = evtsgraqtl qenwumnrbi (vbkcznjwsf ) View more	-	01 Jan 2016

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