Abacavir/dolutegravir/lamivudine

Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV

Retrieved on: 
Tuesday, September 5, 2023

PITTSBURGH and BANGALORE, India, Sept. 5, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced U.S. Food and Drug Administration (FDA) tentative approval for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients.

Key Points: 
  • According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), treatment coverage for children and adolescents lags behind adults.
  • Some 660,000 children living with HIV – about 43 percent of the estimated total 1.5 million [1.2 million–2.1 million] children living with HIV – did not receive antiretroviral (ARV) therapy in 2022.
  • Accordingly, children accounted for 13 per cent of AIDS-related deaths in 2022, even though they comprise only about 4 percent of people living with HIV.
  • The approval of this single tablet regimen – the fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg - will reduce the pill burden for children living with HIV."

ViiV Healthcare presents positive proof-of-concept findings for GSK3640254, a novel, investigational maturation inhibitor for the treatment of HIV

Retrieved on: 
Tuesday, March 9, 2021

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, presented positive data from its phase IIa proof-of-concept study of the investigational maturation inhibitor GSK3640254 (GSK254).

Key Points: 
  • ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, presented positive data from its phase IIa proof-of-concept study of the investigational maturation inhibitor GSK3640254 (GSK254).
  • Maturation inhibitors are a class of antiretroviral medicines that target the late stage of the HIV viral life cycle.
  • These positive proof-of-concept findings show the potential of GSK254 and underscore our commitment to researching and developing a broad range of innovative approaches to treating HIV.
  • ViiV Healthcare has begun the phase IIb study of GSK254, to evaluate the efficacy, safety, and tolerability of this maturation inhibitor as part of a combination therapy for treatment nave adults living with HIV.

Teva Announces New Analysis of Consistency in Migraine Days Over the Course of a Dosing Regimen for AJOVY® (fremanezumab-vfrm) Injection Published in Headache

Retrieved on: 
Wednesday, October 7, 2020

No new safety signals were identified in this population that were inconsistent with the known safety profile of AJOVY.

Key Points: 
  • No new safety signals were identified in this population that were inconsistent with the known safety profile of AJOVY.
  • Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.
  • Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials.
  • Adverse Reactions: The most common adverse reactions (5% and greater than placebo) were injection site reactions.

ViiV Healthcare announces dolutegravir plus lamivudine three-year data confirming long-term viral suppression non-inferior to a 3-drug regimen for treatment-naïve adults with HIV-1

Retrieved on: 
Monday, October 5, 2020

Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression.

Key Points: 
  • Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression.
  • While overall adverse event rates were similar across the study arms, we saw fewer drug-related adverse events with dolutegravir plus lamivudine.
  • Dolutegravir plus lamivudine continued to demonstrate a high genetic barrier to treatment-emergent resistance.
  • These studies evaluate a 2-drug regimen of dolutegravir plus lamivudine compared with a 3-drug regimen of dolutegravir plus TDF/FTC in HIV-1 infected, antiretroviral treatment-nave adult participants with baseline HIV-1 viral loads between 1,000 and 500,000 c/mL.

ViiV Healthcare presents positive long-term data from phase III study demonstrating efficacy and safety of cabotegravir and rilpivirine, its investigational, long-acting, injectable treatment regimen in adults living with HIV-1

Retrieved on: 
Monday, March 9, 2020

The study demonstrated that the 2DR of once-monthly cabotegravir and rilpivirine continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC) at Week 96.

Key Points: 
  • The study demonstrated that the 2DR of once-monthly cabotegravir and rilpivirine continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC) at Week 96.
  • Week 96 results from the global phase III FLAIR study continued to build on the previously reported non-inferiority of long-acting cabotegravir and rilpivirine to daily oral Triumeq at Week 48.
  • The study found that rates of virologic suppression (HIV-1 RNA
  • No new confirmed virologic failure (CVF) was reported between Week 48 and Week 96 among individuals who received long-acting cabotegravir and rilpivirine.

ViiV Healthcare announces phase III study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen

Retrieved on: 
Wednesday, July 10, 2019

No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study.

Key Points: 
  • No patients met confirmed virologic withdrawal criteria or developed treatment resistance in the dolutegravir plus lamivudine arm of the study.
  • The recommended dose of dolutegravir plus lamivudine in adults and adolescents is one 50 mg/300 mg tablet once daily.
  • Dolutegravir plus lamivudine contains dolutegravir and lamivudine, therefore any interactions identified for these individually are relevant to dolutegravir plus lamivudine.
  • Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO).

ViiV Healthcare receives EU Marketing Authorisation for Dovato (dolutegravir/lamivudine), a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection

Retrieved on: 
Wednesday, July 3, 2019

Dovato strengthens ViiV Healthcares industry-leading portfolio of innovative treatment approaches for people living with HIV.

Key Points: 
  • Dovato strengthens ViiV Healthcares industry-leading portfolio of innovative treatment approaches for people living with HIV.
  • Marketing Authorisation for Dovato is supported by data from the landmark global GEMINI 1 and 2 studies that included more than 1,400 HIV-1 infected adults.
  • Chief Scientific and Medical Officer, ViiV Healthcare said: The Marketing Authorisation of Dovato in Europe marks a significant development for people living with HIV.
  • This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.

Global Antiretroviral Drugs Market 2013-2019 & 2023 - Multi-Class Drug Combinations are Predicted to Hold their Dominant Position in the Market

Retrieved on: 
Tuesday, April 9, 2019

DUBLIN, April 9, 2019 /PRNewswire/ -- The "Global Antiretroviral Drugs Market: Analysis By Drug Type, By Region, By Country, Drug Forecast (2019 Edition): Opportunities and Forecast (2013-2023)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, April 9, 2019 /PRNewswire/ -- The "Global Antiretroviral Drugs Market: Analysis By Drug Type, By Region, By Country, Drug Forecast (2019 Edition): Opportunities and Forecast (2013-2023)" report has been added to ResearchAndMarkets.com's offering.
  • Over the recent years, Antiretroviral drugs market has been witnessing growth on account of several driving factors including growing prevalence of HIV AIDS, growing antiretroviral treatment coverage rate, and increase in availability of novel drugs with better efficacy.
  • By drug type, the multi-class drug combinations are predicted to hold their dominant position in the market, especially Gilead Sciences product Biktarvy and ViiV Healthcare product Triumeq are expected to give more traction to the market.
  • Amongst the regions, North America accounts for the largest regional share in the global antiretroviral market in 2017.

US FDA approves ViiV Healthcare’s Dovato (dolutegravir/lamivudine), the first, once-daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults

Retrieved on: 
Monday, April 8, 2019

The approval of Dovato is supported by the landmark global GEMINI 1 and 2 studies that included more than 1,400 HIV-1 infected adults.

Key Points: 
  • The approval of Dovato is supported by the landmark global GEMINI 1 and 2 studies that included more than 1,400 HIV-1 infected adults.
  • The approval of the fixed dose combination of dolutegravir and lamivudine, a complete, single-tablet, two-drug regimen, marks a pivotal moment in the treatment of HIV-1.
  • Jeff Berry, Test Positive Aware Network (TPAN), said: The approval of Dovato is a welcome paradigm shift, as it brings an innovative treatment approach to newly diagnosed adults with HIV-1.
  • Like a DTG-based three-drug regimen, Dovato uses only two drugs to inhibit the viral cycle at two different sites.