Dolutegravir

Viatris Inc. Announces FDA Tentative Approval of a Pediatric Formulation of Dolutegravir (DTG) Under PEPFAR

Retrieved on: 
Monday, November 23, 2020
Hepatotoxins, Integrase inhibitors, Prevention of HIV/AIDS, Dolutegravir, Organofluorides, Management of HIV/AIDS, Medical specialties, Health care, Health

Pediatric dolutegravir tablets were approved for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in pediatric patients at least 4 weeks old and weighing at least 3 kg.

Key Points: 
  • Pediatric dolutegravir tablets were approved for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in pediatric patients at least 4 weeks old and weighing at least 3 kg.
  • The World Health Organization (WHO) recommends this product as part of a preferred first-line treatment regimen for children who meet the criteria.
  • Pediatric dolutegravir tablets are a significant new addition to a product portfolio that has made Viatris the world's largest supplier of ARVs.
  • Viatris undertakes no obligation to update these statements for revisions or changes after the date of this release other than as required by law.

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 announces US FDA approval of the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV

Retrieved on: 
Friday, June 12, 2020
General Health, Infectious diseases, AIDS, Health, Pharmaceutical, Hepatotoxins, Integrase inhibitors, RTT, Drugs, GlaxoSmithKline, Pfizer, ViiV Healthcare, Dolutegravir, Medical specialties, Health care, P1093, Tivicay and Tivicay PD, ViiV Healthcare, GSK

Families affected by HIV will benefit from ViiV Healthcares development of child-friendly formulations that aim to close the gap between treatment options available for adults and children.

Key Points: 
  • Families affected by HIV will benefit from ViiV Healthcares development of child-friendly formulations that aim to close the gap between treatment options available for adults and children.
  • This tailored approach to paediatric treatment of HIV will help meet the urgent needs of this vulnerable population.
  • Todays FDA approval is an important step in fulfilling ViiV Healthcares commitment to bring optimised paediatric formulations of dolutegravir to children.
  • ViiV Healthcare is committed to providing assistance to eligible people living with HIV in the US who need our medicines.

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.

Information Update - New safety information for women using dolutegravir, a medication used to treat HIV infection

Retrieved on: 
Thursday, June 7, 2018
Zoology, Developmental biology, Anatomy, RTT, Dolutegravir, Hepatotoxins, Organofluorides, Neural tube defect, Spinal cord, Neural tube, Nervous system

Dolutegravir is a medication used to treat HIV infection.

Key Points: 
  • Dolutegravir is a medication used to treat HIV infection.
  • Neural tube defects are defects that occur when the spinal cord, brain, and related structures do not form properly.
  • If there is any new safety information, Health Canada will update Canadians, including health professionals, as required.
  • Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.