Lamivudine

Human medicines European public assessment report (EPAR): Ziagen, abacavir, Date of authorisation: 08/07/1999, Revision: 48, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Medical Subject Headings, HIV, Diarrhea, Marketing, Zidovudine, Lethargy, Agency, INN, Risk, Immune system, Fever, Fatigue, ATC, AIDS, International, Cough, HLA, Headache, CD4, Ageing, Nausea, Blood, Somatic symptom disorder, Profile, Rash, Language, Liver, Allergy, Hypersensitivity, European Medicines Agency, Infection, Tablet, Myalgia, Select, Cell, Human, Lamivudine, NRTI, Anatomy, Vomiting, IIA, Periodic breathing, Viral load, Vaccine

Human medicines European public assessment report (EPAR): Ziagen, abacavir, Date of authorisation: 08/07/1999, Revision: 48, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ziagen, abacavir, Date of authorisation: 08/07/1999, Revision: 48, Status: Authorised

ViiV Healthcare to present 23 abstracts from innovative HIV treatment and prevention portfolio at EACS 2023

Retrieved on: 
Wednesday, October 18, 2023
AIDS, Health, Infectious Diseases, General Health, Clinical Trials, Pharmaceutical, Biotechnology, EACS, MPH, III, Biomarker, Rilpivirine, LA, HIV, Safety, Conference, Research, RWE, Shionogi, Titan IIIB, Pfizer, Lamivudine, Medicine, Abstract, HTE, GSK, XVII International AIDS Conference, 2008, ViiV Healthcare, Viral load, SOLAR, Estonia, Pharmaceutical industry, Vaccine, Fostemsavir, European, Dolutegravir/lamivudine

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of key abstracts highlighting the breadth of its approved and investigational medicines at the 19th Annual European AIDS Conference (EACS 2023) being held in Warsaw, Poland from 18-21 October 2023.

Key Points: 
  • ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the presentation of key abstracts highlighting the breadth of its approved and investigational medicines at the 19th Annual European AIDS Conference (EACS 2023) being held in Warsaw, Poland from 18-21 October 2023.
  • Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “Living well with HIV looks different for every individual, and we believe our upcoming presentations at EACS 2023 reflect our commitment and leadership to address the evolving needs of the HIV community.
  • Our latest data from our diverse portfolio and innovative pipeline explore real-world evidence that further evaluate the effectiveness, safety, and tolerability of 2-drug and long-acting regimens; new findings for broadly neutralizing antibodies; and long-term follow-up in heavily treatment-experienced individuals.
  • Here is a list of ViiV Healthcare-sponsored or supported studies being presented at EACS 2023:

ViiV Healthcare presents long-term switch data for Dovato demonstrating non-inferior efficacy in adults with HIV-1 and zero cases of virologic failure versus continuation of a 3-drug TAF-based regimen

Retrieved on: 
Thursday, October 8, 2020
AIDS, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, RTT, Hepatotoxins, Clinical medicine, Medical specialties, Medicine, Hepatology, Integrase inhibitors, Lamivudine, Nucleosides, Dolutegravir, Hepatitis, Alanine transaminase, TANGO, Dovato (dolutegravir/lamivudine), ViiV Healthcare, GSK

Participants were randomised to switch to dolutegravir/lamivudine or continue on the TAF-based regimen through Week 148.

Key Points: 
  • Participants were randomised to switch to dolutegravir/lamivudine or continue on the TAF-based regimen through Week 148.
  • Like a dolutegravir-based three-drug regimen, Dovato uses two drugs to inhibit the viral cycle at two different sites.
  • Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with Dovato.
  • GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer.

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
Science, Biotechnology, Research, Pharmaceutical, AIDS, Health, Infectious diseases, Clinical trials, Hepatotoxins, RTT, Drugs, Dolutegravir, Management of HIV/AIDS, Lamivudine, Abacavir/dolutegravir/lamivudine, Zidovudine, Dolutegravir/lamivudine, GEMINI 1 & 2, Dovato (dolutegravir/lamivudine)

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
Health, Consumer, General Health, Research, Science, Gay & Lesbian, Chemical compounds, Hepatotoxins, Drugs, Organic compounds, RTT, Fixed dose combination, Abacavir/dolutegravir/lamivudine, Integrase inhibitors, Lamivudine, Rilpivirine, Dolutegravir/lamivudine, Cabotegravir

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 Submits Supplemental New Drug Application to US FDA for Use of Dovato in Virologically Suppressed Adults with HIV-1

Retrieved on: 
Wednesday, October 16, 2019
FDA, Health, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, Hepatotoxins, Drugs, RTT, HIV/AIDS, Medical specialties, Integrase inhibitors, Prevention of HIV/AIDS, Management of HIV/AIDS, Lamivudine, Dolutegravir/lamivudine, Zidovudine, Dolutegravir, ViiV Healthcare, GSK

Todays submission takes us a step closer toward offering this option for virologically suppressed adults living with HIV who are looking to treat HIV with fewer drugs.

Key Points: 
  • Todays submission takes us a step closer toward offering this option for virologically suppressed adults living with HIV who are looking to treat HIV with fewer drugs.
  • Use of Dovato in virologically suppressed adults on a stable antiretroviral regimen with no treatment failure replacing their current therapy is subject to FDA approval.
  • The following ISI is based on the Highlights section of the Prescribing Information for Dovato.
  • 2 Clinical trials.gov Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO).

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
Biotechnology, Pharmaceutical, AIDS, Health, Infectious diseases, Clinical trials, Hepatotoxins, RTT, Drugs, Integrase inhibitors, Fixed dose combination, Lamivudine, Nucleosides, Dolutegravir, Abacavir/dolutegravir/lamivudine

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).

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
Health, AIDS, Biotechnology, Clinical trials, Infectious diseases, Pharmaceutical, Research, FDA, Consumer, Science, Gay & Lesbian, Hepatotoxins, RTT, Drugs, Integrase inhibitors, Medical specialties, Medicine, Dolutegravir, Organofluorides, Lamivudine, Abacavir/dolutegravir/lamivudine

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.

China Lamivudine Market Report 2018: Market is Dominated by GSK, Wellcome Foundation, Anhui Biochem Bio-Pharmaceutical and Hunan Qianjin Xiangjiang Pharmaceutical Joint Stock

Retrieved on: 
Wednesday, September 26, 2018
Health, RTT, Medicine, Hepatotoxins, Lamivudine, Nucleosides, GlaxoSmithKline, HIV/AIDS in China, GlaxoSmithKline Pharmaceuticals Ltd, Pharmaceutical industry in China, Hepatitis, Pharmaceutical industry

At the end of 2017, there were more than 700,000 registered HIV-infected persons and AIDS patients in China.

Key Points: 
  • At the end of 2017, there were more than 700,000 registered HIV-infected persons and AIDS patients in China.
  • Lamivudine is a major drug against the hepatitis B virus and AIDS in China.
  • The market is dominated by GlaxoSmithKline Pharmaceuticals (Suzhou) Co., Ltd., Wellcome Foundation, Anhui Biochem Bio-Pharmaceutical Co., Ltd. and Hunan Qianjin Xiangjiang Pharmaceutical Joint Stock Co., Ltd. GlaxoSmithKline Pharmaceuticals (Suzhou) Co., Ltd. has the largest market share.
  • Considering the large number of hepatitis B and AIDS patients in China, it is expected that the market size of China's Lamivudine market will continue to grow.