Integrase inhibitors

ViiV Healthcare study shows new long-acting HIV regimen Cabenuva (cabotegravir/rilpivirine) can be successfully implemented in broad range of US healthcare practices, even during COVID-19

Retrieved on: 
Saturday, July 17, 2021

Additionally, this regimen remained highly acceptable both to healthcare providers and people living with HIV and was strongly preferred by study participants to daily oral therapy.

Key Points: 
  • Additionally, this regimen remained highly acceptable both to healthcare providers and people living with HIV and was strongly preferred by study participants to daily oral therapy.
  • A corresponding trial in Europe, CARISEL, is examining the implementation of long-acting cabotegravir and rilpivirine, dosed every 2-months in certain European healthcare settings.
  • Marketing Authorisations for the long-acting regimen of cabotegravir and rilpivirine were granted by the European Medicines Agency in December 2020.
  • Sustainment of implementation strategies was assessed via surveys and semi-structured interviews of staff study participants as well as patient study participants.

HIV medicines among latest hard-to-find drugs available through AllianceRx Walgreens Prime

Retrieved on: 
Tuesday, May 4, 2021

b'ORLANDO, Fla., May 4, 2021 /PRNewswire/ -- Cabenuva (cabotegravir/rilpivrine), the first and only once-monthly complete injectable treatment is available through AllianceRx Walgreens Prime for adults living with human immunodeficiency virus type 1 (HIV-1).

Key Points: 
  • b'ORLANDO, Fla., May 4, 2021 /PRNewswire/ -- Cabenuva (cabotegravir/rilpivrine), the first and only once-monthly complete injectable treatment is available through AllianceRx Walgreens Prime for adults living with human immunodeficiency virus type 1 (HIV-1).
  • One in five people living with HIV suffer from chronic diarrhea.\n"I\'m proud of the fact that manufacturers choose AllianceRx Walgreens Prime to manage these life-changing medications for individuals with these conditions," says Tracey James, RPh, senior vice president of pharmacy services at AllianceRx Walgreens Prime.
  • "\nAllianceRx Walgreens Prime, one of the largest specialty and home delivery pharmacies in the country, provides medicine for patients with certain rare, chronic and complex conditions.
  • Known as limited distribution drugs (LDDs), the following specialty medicines are also now available through AllianceRx Walgreens Prime:\nXtandi (enzalutamide) capsules and tablets, manufactured by Astellas, is used to treat prostate cancer when surgery or other medicines have not worked or have stopped working.

ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV

Retrieved on: 
Tuesday, May 4, 2021

With only six dosing days per year, long-acting cabotegravir would provide an option that eliminates the need for adherence to a daily pill.

Key Points: 
  • With only six dosing days per year, long-acting cabotegravir would provide an option that eliminates the need for adherence to a daily pill.
  • The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection.
  • This translated to an HIV incidence rate of 0.38% (95% confidence interval [CI] 0.20%-0.66%) in the cabotegravir group and 1.22% (95% CI 0.86%-1.66%) in the FTC/TDF group.
  • ISRs in HPTN 084 occurred more frequently in the cabotegravir arm (32%) vs. the FTC/TDF arm (9%), which received placebo injections.

Gilead and Merck Announce Agreement to Jointly Develop and Commercialize Long-Acting, Investigational Treatment Combinations of Lenacapavir and Islatravir in HIV

Retrieved on: 
Monday, March 15, 2021

Through this agreement with Merck, Gilead is reinforcing its long-term role in transforming HIV care, said Daniel ODay, Chairman and Chief Executive Officer, Gilead Sciences.

Key Points: 
  • Through this agreement with Merck, Gilead is reinforcing its long-term role in transforming HIV care, said Daniel ODay, Chairman and Chief Executive Officer, Gilead Sciences.
  • Lenacapavir and islatravir, alone and in combination, are investigational and not approved anywhere globally.
  • Beyond the potential combinations of lenacapavir and islatravir, Gilead will have the option to license certain of Mercks investigational oral integrase inhibitors to develop in combination with lenacapavir.
  • Reciprocally, Merck will have the option to license certain of Gileads investigational oral integrase inhibitors to develop in combination with islatravir.

Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression in Treatment-Naïve Adults in Four-Year Data Presented at CROI

Retrieved on: 
Saturday, March 6, 2021

The data were presented at the 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021).

Key Points: 
  • The data were presented at the 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021).
  • The high efficacy and durable viral suppression were also observed in participants who switched to Biktarvy from a dolutegravir-containing triple therapy for the 48-week OLE periods (n=212 for study 1489, n=225 for study 1490).
  • These data reinforce that Biktarvy provides durable viral suppression, strong efficacy and a high barrier to resistance in both adults that are new to HIV therapy and those replacing their existing treatment.
  • The data presented at CROI highlight that Biktarvy can achieve long-term viral suppression at four years among a range of people living with HIV and supports further study for patients with certain transmitted drug-resistant HIV.

 ViiV Healthcare Submits Supplemental New Drug Application to US FDA for Expanded Use of Cabenuva (cabotegravir, rilpivirine) as an HIV Treatment for Use Every 2-Months

Retrieved on: 
Wednesday, February 24, 2021

Cabenuva is a complete long-acting regimen with two separate injectable medicines, ViiV Healthcares cabotegravir and rilpivirine, a product of Janssen Sciences Ireland UC.

Key Points: 
  • Cabenuva is a complete long-acting regimen with two separate injectable medicines, ViiV Healthcares cabotegravir and rilpivirine, a product of Janssen Sciences Ireland UC.
  • The medication was approved by the FDA in January 2021 as a once monthly treatment for HIV-1 infection in virologically suppressed adults.
  • At ViiV Healthcare, we will continue to advance new approaches to care as part of our mission of leaving no person living with HIV behind.
  • Cabenuva is administered as two intramuscular injections (cabotegravir, rilpivirine) in the buttocks during the same visit by a healthcare professional.

Global Antiretroviral Therapy Market Outlook to 2024, Featuring Company Profiles of Key Players Gilead Sciences, GSK, Roche Holding, Boehringer Ingelheim, Cipla and Abbvie

Retrieved on: 
Thursday, January 21, 2021

The global antiretroviral therapy market is anticipated to reach US$ 35.14 billion in 2024.

Key Points: 
  • The global antiretroviral therapy market is anticipated to reach US$ 35.14 billion in 2024.
  • The global antiretroviral therapy market is also prone to certain challenges like increasing voluntary male circumcisions and the 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 competitive landscape of the market, along with the company profiles of leading players (Gilead Sciences, GSK, Roche Holding, Boehringer Ingelheim, Cipla and Abbvie) are also presented in detail.

Global HIV Drugs Market (2020 to 2027) - by Medication Class, Non-nucleoside Reverse Transcriptase Inhibitors and HIV Integrase Strand Transfer Inhibitors - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 19, 2021

The "Global HIV Drugs Market By Medication Class, Non-nucleoside Reverse Transcriptase Inhibitors and HIV Integrase Strand Transfer Inhibitors: Opportunity Analysis and Industry Forecast, 2020-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global HIV Drugs Market By Medication Class, Non-nucleoside Reverse Transcriptase Inhibitors and HIV Integrase Strand Transfer Inhibitors: Opportunity Analysis and Industry Forecast, 2020-2027" report has been added to ResearchAndMarkets.com's offering.
  • The global HIV drugs market is bifurcated into medication class and region.
  • On the basis of medication class, the market is classified into multi-class combination drugs, nucleoside reverse transcriptase inhibitors (NRTIs), non Onucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), entry inhibitors, and HIV integrase strand transfer inhibitors.
  • The key market players and their strategies have been analyzed to understand the competitive outlook of the market.

ViiV Healthcare announces the Marketing Authorisation of the first complete long-acting injectable HIV treatment in Europe

Retrieved on: 
Monday, December 21, 2020

This authorisation represents the first time people living with HIV in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase.

Key Points: 
  • This authorisation represents the first time people living with HIV in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase.
  • Cabotegravir is an INI developed by ViiV Healthcare for the treatment of HIV-1 in virologically suppressed adults.
  • Cabotegravir and rilpivirine injections are administered as two IM injections in the buttocks by a Healthcare Professional at the same appointment.
  • Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus.

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

Retrieved on: 
Monday, November 23, 2020

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.