Integrase inhibitors

Gilead Announces Investigational Long-Acting HIV-1 Capsid Inhibitor, Lenacapavir, Achieves Primary Endpoint in Phase 2/3 Study in Heavily Treatment-Experienced People Living With HIV

Retrieved on:

Wednesday, November 18, 2020

AIDS, Health, Infectious diseases, Hospitals, Clinical trials, Pharmaceutical, Biotechnology, Specialty drugs, Life sciences, Biotechnology, Gilead Sciences, Drugs, Integrase inhibitors, Breakthrough therapy, Prodrugs

Treatment options that address the complex needs of heavily treatment-experienced people living with multidrug resistant HIV remain a significant unmet need.

Key Points:

Treatment options that address the complex needs of heavily treatment-experienced people living with multidrug resistant HIV remain a significant unmet need.
If approved, lenacapavir would be the first HIV capsid inhibitor available for the treatment of HIV-1 infection.
Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.
For more information about Gilead, please visit the companys website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

ViiV Healthcare receives FDA Breakthrough Therapy Designation for investigational, long-acting cabotegravir for HIV prevention

Retrieved on:

Tuesday, November 17, 2020

Research, FDA, Clinical trials, Gay & Lesbian, Biotechnology, AIDS, Pharmaceutical, Consumer, Health, Science, HIV Prevention Trials Network, Integrase inhibitors, Health sciences, HPTN 083, Cabotegravir, Prevention of HIV/AIDS, Health, Breakthrough therapy, Pre-exposure prophylaxis

The Breakthrough Therapy Designation is intended to facilitate the development and expedite the review of drugs that address serious or life-threatening medical conditions.

Key Points:

The Breakthrough Therapy Designation is intended to facilitate the development and expedite the review of drugs that address serious or life-threatening medical conditions.
Our data from the HPTN 083 and 084 studies show that long-acting cabotegravir is superior to daily oral FTC/TDF tablets for HIV prevention.
We are looking forward to working closely with the FDA to make this prevention option available to people at risk of acquiring HIV.
Advancements in research and development have identified new approaches to HIV treatment and prevention, such as long-acting cabotegravir.

ViiV Healthcare announces investigational injectable cabotegravir is superior to oral standard of care for HIV prevention in women

Retrieved on:

Monday, November 9, 2020

The results of HPTN 084 confirm long-acting cabotegravirs potential as an HIV prevention option that can meet these needs.

Key Points:

The results of HPTN 084 confirm long-acting cabotegravirs potential as an HIV prevention option that can meet these needs.
The data showed that there was a statistically significant advantage for the women who received cabotegravir compared with the women who received FTC/TDF.
While both were highly effective at preventing HIV in the study population, cabotegravir was superior.
Cabotegravir is an investigational integrase inhibitor being developed by ViiV Healthcare for the treatment and prevention of HIV.

Gilead Announces New Data on Biktarvy® for the Treatment of HIV in Black Americans

Retrieved on:

Wednesday, October 21, 2020

AIDS, Health, Hospitals, Clinical trials, Pharmaceutical, Biotechnology, Articles, Specialty drugs, Bictegravir/emtricitabine/tenofovir alafenamide, Biotechnology, HIV/AIDS, Life sciences, Gilead Sciences, Integrase inhibitors

Black and African Americans in this country have the highest rates of new HIV infections every year compared to other races.

Key Points:

Black and African Americans in this country have the highest rates of new HIV infections every year compared to other races.
As drug resistance builds, treatment options become more limited, sometimes leading to less desirable, but often necessary, complicated treatment regimens.
These data from BRAAVE 2020, a landmark study, designed with community input to understand specific treatment responses of Black and African Americans, show Biktarvy is an effective regimen for Black Americans, including those with a history of some drug resistance.
Biktarvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

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

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 Availability of CABENUVA and VOCABRIA in Canada

Retrieved on:

Wednesday, September 23, 2020

Chemical compounds, Non-nucleoside reverse transcriptase inhibitors, Integrase inhibitors, Nitriles, Pyrimidines, Organic compounds, Drugs, Rilpivirine, Prevention of HIV/AIDS, ViiV Healthcare, Reverse-transcriptase inhibitor, Cabotegravir

LAVAL, QC, Sept. 23, 2020 /CNW/ - Today, ViiV Healthcare Canada announced stock availability of CABENUVA and VOCABRIA across the country.

Key Points:

LAVAL, QC, Sept. 23, 2020 /CNW/ - Today, ViiV Healthcare Canada announced stock availability of CABENUVA and VOCABRIA across the country.
It combines the integrase strand transfer inhibitor (INSTI)cabotegravir with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine.1[VOCABRIA and CABENUVA PM p4A,26A]
Both CABENUVA and VOCABRIA received approval from Health Canada on March 18, 2020.
VOCABRIA, oral cabotegravir, together with Janssen Pharmaceutical Companies of Johnson & Johnson's EDURANT, oral rilpivirine, is used for the short-term treatment of HIV-1 infection in adults who are virologically stable and suppressed prior to initiating CABENUVA.1 [VOCABRIA and CABENUVA PM p4A]
Dacia Hibbert, General Manager of ViiV Healthcare Canada, said: "We are proud to make CABENUVA and VOCABRIA available to people living with HIV.
Prior to initiating treatment with CABENUVA, oral dosing of VOCABRIA and EDURANT was administered for approximately one month to assess the tolerability of cabotegravir and rilpivirine.

ViiV Healthcare Announces Superior Efficacy of Investigational, Long-Acting Injectable Formulation of Cabotegravir Dosed Every Two Months Over Daily Oral PrEP

Retrieved on:

Tuesday, July 7, 2020

Final analysis has since confirmed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets.

Key Points:

Final analysis has since confirmed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: These data are truly ground-breaking, demonstrating that long-acting injectable cabotegravir dosed every two months is superior to daily oral FTC/TDF at preventing HIV in at-risk men and transgender women who have sex with men.
Injection site reactions, pyrexia, and hypertension were more common in the cabotegravir arm while nausea was more common in the FTC/TDF arm.
HPTN 083 was jointly funded by the U.S. NIAID, part of the NIH, and ViiV Healthcare, and was conducted by the HPTN.

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.

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

Retrieved on:

Saturday, May 23, 2020

Hepatotoxins, Prevention of HIV/AIDS, Management of HIV/AIDS, Integrase inhibitors, Drugs, RTT, Medical specialties, Reverse-transcriptase inhibitor, Chemical substances, Protease inhibitor, Zidovudine, Treatment as prevention

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

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.