Management of HIV/AIDS

J. Craig Venter Institute Scientists to Investigate Role of Opioid Abuse in HIV and HIV-Associated Neurocognitive Disorders Pathogenesis through $4.7M NIDA Grant

Retrieved on: 
Thursday, February 25, 2021

Opioid misuse is a route of contracting HIV and a barrier to effective antiretroviral therapy (ART).

Key Points: 
  • Opioid misuse is a route of contracting HIV and a barrier to effective antiretroviral therapy (ART).
  • However, it is unclear whether opioid misuse changes the course of HIV pathogenesis, especially on HAND.
  • Funding for this work is provided by the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), grant 7UM1DA051411-02.
  • The J. Craig Venter Institute (JCVI) is a not-for-profit research institute in Rockville, Maryland and La Jolla, California.

ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment

Retrieved on: 
Thursday, January 21, 2021

The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV.

Key Points: 
  • The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV.
  • ViiV Healthcare will begin shipping Cabenuva to wholesalers and specialty distributors in the US in February 2021.
  • Because Cabenuva is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
  • ViiV Healthcare is committed to providing assistance to eligible people living with HIV in the US who need our medicines.

ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment

Retrieved on: 
Thursday, January 21, 2021

The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV.

Key Points: 
  • The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV.
  • ViiV Healthcare will begin shipping Cabenuva to wholesalers and specialty distributors in the US in February 2021.
  • Because Cabenuva is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
  • ViiV Healthcare is committed to providing assistance to eligible people living with HIV in the US who need our medicines.

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.

FDA Accepts Protocol for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients

Retrieved on: 
Thursday, December 31, 2020

Hospitals previously participating in the CD12 trial now have the option of enrolling additional eligible patients, with all patients receiving leronlimab.

Key Points: 
  • Hospitals previously participating in the CD12 trial now have the option of enrolling additional eligible patients, with all patients receiving leronlimab.
  • CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2.
  • CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded

Retrieved on: 
Friday, December 25, 2020

The CD12 protocol will be amended for adding the open-label arm extension and submitted to the FDA on Monday, December 28, 2020.

Key Points: 
  • The CD12 protocol will be amended for adding the open-label arm extension and submitted to the FDA on Monday, December 28, 2020.
  • Upon clearance, each CD12 participating clinical trial site will have the option of enrolling additional qualified patients, with all patients receiving leronlimab.
  • We are committed to work with the FDA and the health care providers to improve the outcomes of COVID patients.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

HIV is turning gray: Will the Biden White House Accept the Challenge?

Retrieved on: 
Friday, December 18, 2020

Some years later, the human immunodeficiency virus (HIV) caused AIDS was discovered, and it started the dark legacy that lives on today.

Key Points: 
  • Some years later, the human immunodeficiency virus (HIV) caused AIDS was discovered, and it started the dark legacy that lives on today.
  • Significant advances in care and treatment mean people with HIV are living longer.
  • In the U.S. today, young adults with HIV-infection who adhere to their antiretroviral treatment maintain lower viral loads and live longer.
  • Older HIV patients struggle to cope with many obstacles among them mental health problems, homelessness, and co-morbidities daily.

CytoDyn Announces First Patient Enrolled in Phase 2 Trial for NASH

Retrieved on: 
Wednesday, December 2, 2020

CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

Key Points: 
  • CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.
  • CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.

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.