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

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.

01 Sep 2024·HIV MEDICINE

De‐simplifying antiretroviral therapy from a single‐tablet to a two‐tablet regimen: Acceptance, patient‐reported outcomes, and cost savings in a multicentre study

Article

Author: Weijsenfeld, A. M. ; Langebeek, N. ; Brinkman, K. ; van Luin, M. ; Vanhommerig, J. W. ; van Crevel, R. ; de Zoete, B. G. J. A. ; Gisolf, E. H. ; van der Valk, M. ; Grintjes, K. ; Burger, D. M. ; Oosterhof, P. ; Lammers, A. J. J. ; van Hulzen, A. G. W.

Abstract:

Background:

Antiretroviral therapy (ART), which is increasingly used by people with HIV, accounts for significant care costs, particularly because of single‐tablet regimens (STRs). This study explored de‐simplification to a two‐tablet regimen (TTR) for cost reduction. The objectives of this study were: (1) acceptance of de‐simplification, (2) patient‐reported outcomes, and (3) cost savings.

Methods:

All individuals on Triumeq®, Atripla® or Eviplera® in five HIV clinics in the Netherlands were eligible. Healthcare providers informed individuals of this study. After inclusion, individuals were free to de‐simplify. An electronic questionnaire was sent to assess study acceptance, adherence, quality of life (SF12) and treatment satisfaction (HIVTSQ). After 3 and 12 months, questionnaires were repeated. Cost savings were calculated using Dutch drug prices.

Results:

In total, 283 individuals were included, of whom 55.5% agreed to de‐simplify their ART, with a large variability between treatment centres: 41.1–74.2%. Individuals who were willing to de‐simplify tended to be older, had a longer history of HIV diagnosis, and used more co‐medication than those who preferred to remain on an STR regimen. Patient‐reported outcomes, including quality of life and treatment satisfaction, showed no significant difference between people with HIV who switched to a TTR and those who remained on an STR regimen. Furthermore, we observed a 17.8% reduction in drug costs in our cohort of people with HIV who were initially on an STR.

Conclusions:

De‐simplification from an STR to a TTR within the Dutch healthcare setting has been demonstrated as feasible, leads to significant cost reductions and should be discussed with every eligible person with HIV in the Netherlands.

01 Nov 2023·Molecular neurobiology

The Molecular Link Between TDP-43, Endogenous Retroviruses and Inflammatory Neurodegeneration in Amyotrophic Lateral Sclerosis: a Potential Target for Triumeq, an Antiretroviral Therapy

Review

Author: Rogers, Mary-Louise ; Theunissen, Frances ; Dubowsky, Megan ; Carr, Jillian M

Abstract:

Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), is a progressive neurological disorder, characterised by the death of upper and lower motor neurons. The aetiology of ALS remains unknown, and treatment options are limited. Endogenous retroviruses (ERVs), specifically human endogenous retrovirus type K (HERV-K), have been proposed to be involved in the propagation of neurodegeneration in ALS. ERVs are genomic remnants of ancient viral infection events, with most being inactive and not retaining the capacity to encode a fully infectious virus. However, some ERVs retain the ability to be activated and transcribed, and ERV transcripts have been found to be elevated within the brain tissue of MND patients. A hallmark of ALS pathology is altered localisation of the transactive response (TAR) DNA binding protein 43 kDa (TDP-43), which is normally found within the nucleus of neuronal and glial cells and is involved in RNA regulation. In ALS, TDP-43 aggregates within the cytoplasm and facilitates neurodegeneration. The involvement of ERVs in ALS pathology is thought to occur through TDP-43 and neuroinflammatory mediators. In this review, the proposed involvement of TDP-43, HERV-K and immune regulators on the onset and progression of ALS will be discussed. Furthermore, the evidence supporting a therapy based on targeting ERVs in ALS will be reviewed.Graphical Abstract

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

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

24 Jan 2025

·www.pharmaceutical-technology.com

FDA approves drug application for Lupin’s heart failure therapy

The approval covers dosages of the medicine comprising 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg. Credit: Shidlovski/Shutterstock. The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin ’s Sacubitril and Valsartan tablets for heart failure patients. Sacubitril and Valsartan tablets are the generic equivalent of Novartis ‘ Entresto, used to reduce cardiovascular risks in adults with chronic heart failure and decreased ejection fraction. The approval covers dosages of 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg. They are also used for treating symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older. The tablets are expected to tap into a market with annual US sales of $6.06bn. The company has also announced the receipt of tentative approval from the US regulator under the US President’s Emergency Plan for AIDS Relief (PEPFAR) for its Abacavir, Dolutegravir and Lamivudine tablets for oral suspension. This generic equivalent of ViiV Healthcare’s Triumeq PD tablets for oral suspension is set to be manufactured at the company’s Nagpur facility in India. The tablets are for distribution in low and middle-income nations. The Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg fixed-dose combo is intended for the treatment of human immunodeficiency virus (HIV)-1 infection in children aged three and above weighing at least 6kg, and is a once-a-day single-pill regimen. Lupin API Plus SBU head, global chief financial officer and executive director Ramesh Swaminathan stated: “We are committed to providing affordable and high-quality treatments for patients worldwide. The tentative approval from the US FDA for our Abacavir, Dolutegravir and Lamivudine tablets enables us to improve the well-being of paediatric patients with HIV-1, thereby significantly boosting our HIV medication portfolio.” In September 2024, the company entered a non-exclusive patent licence agreement with Takeda Pharmaceutical for the commercialisation of Vonoprazan tablets in India.

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100 Deals associated with Abacavir sulfate/Dolutegravir sodium/Lamivudine

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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

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04827134 (CTgov)	Phase 1	HIV Infections	33	TRIUMEQ+DTG+ABC+3TC (Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed)	vxgijcppid(ksqdweizqb) = lrzlgovfey ncnoqddoxk (bfskkdfkeu, 25.7) View more	-	05 Jun 2023
				DTG+ABC+3TC (Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted)	vxgijcppid(ksqdweizqb) = pgffdqtzal ncnoqddoxk (bfskkdfkeu, 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))	tevgvrhtdn(qchugxiqvq) = dvixzhqlvl vwmheodqsc (likbtlxaxg, 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))	tevgvrhtdn(qchugxiqvq) = rzlsoxgqqc vwmheodqsc (likbtlxaxg, 50.6) View more
NCT02075593 (200336, CTgov)	Phase 3	HIV Infections	4	DTG+3TC+ABC (DTG/ABC/3TC - Mother)	nbyhzmakqu(bxuvahdzux) = nkpezrlmoz zdrpgwzyle (rsfkplyhgg, clgtywaluq - jqrdknwerj) View more	-	18 Feb 2022
				DTG+3TC+ABC (DTG/ABC/3TC - Infant)	lpwfaghkeb(cmodyipevn) = umghreviks ixzyjyqzjz (wuigeolrll, 1.71) View more
NCT02105987 (STRIIVING, Pubmed 1 \| Pubmed 2 \| Antivir Ther)	Phase 3	HIV Infections	553	Abacavir/Dolutegravir/Lamivudine	nzfpoqbgcw(iwjjarpntv) = bqrvubmtnx lfharoeefq (jzlphogaqh ) View more	Non-inferior	01 May 2017
				Current ART	nzfpoqbgcw(iwjjarpntv) = sjeojsvfnm lfharoeefq (jzlphogaqh ) 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)	ipxsjapkvr = wqdcqorhys qsjvepstcw (kpiiyawiei, gogzhsvsts - jmgpnjrudf) View more	-	31 Oct 2016
				FTC+ATV+TDF+RTV (ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase)	ipxsjapkvr = egfnkgbilp qsjvepstcw (kpiiyawiei, aohwcjhria - nhnwlidhal) 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)	ghkzpkrdab = wesxbvrmee fajsumhqaf (nwwdcavajd, zmlbiixcle - axvvpfveuw) View more	-	25 Feb 2016
				DTG+ABC+3TC (Current ART)	ghkzpkrdab = amdjtcwizm fajsumhqaf (nwwdcavajd, poxfdhzcgk - pamypwwedc) View more
NCT01910402 (ARIA Study, IAS 12016 \| IAS 22016)	Phase 3	HIV Infections	495	DTG/ABC/3TC	gnkkzianpq(zpvsmutfmh) = qxakvwswsz rdfqfdydcn (siyzlbeztq ) View more	-	01 Jan 2016

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