Integrase inhibitors

Global Antiretroviral Therapy Market (NRTI, NNRTI, Protease Inhibitors & Integrase Inhibitors): Insights & Forecast with Potential Impact of COVID-19 (2020-2024)

Saturday, May 23, 2020 - 12:20am

The global antiretroviral therapy market is also prone to certain challenges like increasing voluntary male circumcisions and huge cost of treatment.

Key Points: 
  • The global antiretroviral therapy market is also prone to certain challenges like increasing voluntary male circumcisions and huge cost of treatment.
  • The global antiretroviral therapy market by drug type can be segmented into the following: NRTI, NNRTI, protease inhibitors and integrase inhibitors.
  • The global antiretroviral therapy market by region can be segmented into the following regions: North America, Europe and Asia Pacific.
  • The report provides a comprehensive analysis of the global antiretroviral therapy market with potential impact of COVID-19.

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

Monday, March 9, 2020 - 6:30pm

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

Wednesday, October 16, 2019 - 12:00pm

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 Reports Positive Phase III Study Results of Investigational, Long-acting, Injectable HIV-Treatment Regimen Administered Every Two Months

Thursday, August 22, 2019 - 7:17am

The study met its primary endpoint, showing that the long-acting regimen of cabotegravir and rilpivirine, injected every two months, was non-inferior to cabotegravir and rilpivirine administered every month at Week 48.

Key Points: 
  • The study met its primary endpoint, showing that the long-acting regimen of cabotegravir and rilpivirine, injected every two months, was non-inferior to cabotegravir and rilpivirine administered every month at Week 48.
  • Overall safety, virologic response and drug resistance results for the every-two-months injectable regimen were consistent with results from the phase III ATLAS study.
  • A Priority Review Designation for the once-monthly injectable regimen was granted by the FDA with an expected action date of December 29, 2019.
  • 1 Study evaluating the efficacy, safety, and tolerability of long-acting cabotegravir plus long-acting rilpivirine administered every 8 weeks in virologically suppressed HIV-1-infected adults.

China National Medical Products Administration Approves Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection

Friday, August 9, 2019 - 1:30pm

Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.

Key Points: 
  • Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
  • In China, Biktarvy is indicated for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
  • The government of China has provided free antiretroviral treatment to all persons living with HIV since 2003.
  • Biktarvy received marketing approval from the U.S. Food and Drug Administration (FDA) and the European Commission in 2018.

ViiV Healthcare Submits Regulatory Application to European Medicines Agency for Investigational Cabotegravir to Be Used in Combination With Rilpivirine as the First Monthly, Injectable Treatment for HIV

Monday, July 29, 2019 - 7:06am

The application also includes data for cabotegravir oral tablets, intended for use as oral lead-in therapy prior to the commencement of injectable therapy.

Key Points: 
  • The application also includes data for cabotegravir oral tablets, intended for use as oral lead-in therapy prior to the commencement of injectable therapy.
  • Deborah Waterhouse, CEO of ViiV Healthcare, said: ViiV Healthcare is proud to be sending a regulatory submission to the EMA for what will be a first-of-its-kind treatment.
  • ViiV Healthcare and Janssen also plan to submit additional regulatory applications for cabotegravir and rilpivirine to other regulatory agencies in the coming months.
  • Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV.

Janssen Submits Regulatory Application to European Medicines Agency for Rilpivirine Long Acting, to Be Used in Combination with Cabotegravir Long Acting, as the First Monthly Injectable Treatment for HIV

Monday, July 29, 2019 - 7:00am

If approved, the two-drug regimen will be the first monthly LA injectable treatment for HIV infection in adults whose viral load is suppressed and who are not resistant to rilpivirine or cabotegravir.

Key Points: 
  • If approved, the two-drug regimen will be the first monthly LA injectable treatment for HIV infection in adults whose viral load is suppressed and who are not resistant to rilpivirine or cabotegravir.
  • Janssen has a rich history of innovation in HIV and we are passionate about continuing the fight.
  • We look forward to continuing our work with ViiV Healthcare to bring the first long-acting injectable HIV treatment to patients across Europe.
  • ViiV Healthcare and Janssen also plan to submit additional parallel regulatory applications for cabotegravir LA and rilpivirine LA to other agencies globally in the coming months.

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

Wednesday, July 10, 2019 - 7:16am

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).

Isentress - API Insight, 2019 - ResearchAndMarkets.com

Friday, May 31, 2019 - 10:05am

The "Isentress - API Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Isentress - API Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • Isentress - API Insight, 2019 provides product and API manufacturers' details across the globe along with the location.
  • The report gives the clear idea on the country wise DMF filed by worldwide companies related to Isentress.
  • The report also highlights the patent details of Isentress.

ViiV Healthcare Submits New Drug Application to US FDA for the First Monthly, Injectable, Two-Drug Regimen of Cabotegravir and Rilpivirine for Treatment of HIV

Monday, April 29, 2019 - 12:06pm

ViiV Healthcare is proud to be at the forefront of this innovation in HIV treatment and we look forward to working with the FDA to provide people living with HIV in the US this novel option.

Key Points: 
  • ViiV Healthcare is proud to be at the forefront of this innovation in HIV treatment and we look forward to working with the FDA to provide people living with HIV in the US this novel option.
  • If approved, people receiving the monthly injectable regimen of cabotegravir and rilpivirine will reduce the number of days they have to take treatment from 365 to 12 per year.
  • ViiV Healthcare and Janssen plan to submit regulatory applications for the two-drug regimen of cabotegravir and rilpivirine to the European Medicines Agency, Health Canada and other global agencies in the coming months.
  • Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV.