Posts Tagged ‘ViiV’

Congratulations to the grant awardees that will be able to do additional work to improve the barriers and disparities communities in the south face when it comes to HIV&AIDS.  More information can be found below in the official press release.


Positive Action Southern Initiative Commitment Continues with New Grants Awarded to Seven Organizations, Bringing Total Funding for Grassroots Projects to More than 2.8 Million to Date

 

Research Triangle Park, NC – October 20, 2014 – ViiV Healthcare today announced seven Positive Action Southern Initiative grant awardees in Georgia, Louisiana and Mississippi for programs focused on reducing disparities in HIV/AIDS linkages to care and treatment among at-risk populations in their communities.  Recipients will receive up to $50,000 per year for a provisional commitment over the next two years to support the following programs:

  • Atlanta Harm Reduction Coalition, Inc., located in Atlanta, GA, will enhance their Linkage to Treatment program and enhance the reach and depth of their services to HIV positive individuals.
  • Brotherhood, Inc., located in New Orleans, LA, will expand their work to address the needs of HIV positive African American transgender persons and men who have sex with men (MSM) who are recently released from prison.
  • Family Services of Greater Baton Rouge, located in Baton Rouge, LA, will enhance their work to address gaps in services for HIV positive individuals recently released from prison.
  • Grace House, Inc., located in Jackson, MS, will expand its supportive services to homeless Mississippians living with and affected by HIV/AIDS.
  • My Brother’s Keeper, Inc., located in Ridgeland, MS, will fill gaps in their current services by expanding HIV prevention and research programs for African American MSM to include case management.
  • SisterLove, Inc., located in Atlanta, GA, will enhance their “Everyone Has A Story” (EHAS) program through a series of trainings/webinars to build the capacity and skills of peer advocates, staff, and volunteers.
  • Someone Cares Inc. of Atlanta, located in Atlanta, GA, will improve their Transforming, Renewing and Unifying Transgender Health Project (TRUTH) intervention to support transgender women of color.

Since its launch in 2010, the Positive Action Southern Initiative has helped to enable effective interventions and quality services to fight HIV in Southern states.  In addition to receiving funding, grantees also become part of the Southern Initiative Network, a resource that supports grantees and grantee finalists through networking activities, including opportunities to share lessons learned with one another and with other community experts. This collaborative network has now grown to include 32 organizations working together to share effective strategies for addressing the HIV/AIDS crisis in the South.

“The Positive Action Southern Initiative is a direct reflection of our commitment to working together with the community to improve outcomes for those populations disproportionately affected by HIV, and we continue to be impressed by the innovative ideas and strong results put forth by the Network,” said Bill Collier, Head of North America, ViiV Healthcare.  “With round six of the program, we’re proud to continue funding effective community-based initiatives, which are essential to meeting the goals of the National HIV/AIDS Strategy and reducing HIV-related disparities in the Southern United States.”

Designed to address the gaps in care and treatment documented through the Gardner Cascade[i], the Positive Action Southern Initiative reflects the White House National HIV/AIDS Strategy by directing resources to areas and populations that have the greatest need. The Southern United States is disproportionately impacted by HIV/AIDS, representing 45 percent of all new AIDS diagnoses.[ii]

“The Southern AIDS Coalition and the Positive Action Southern Initiative were born of the same purpose – to effectively address the disparate impact of HIV on the Southern United States,” said Rainey Campbell, Executive Director of the Southern AIDS Coalition. “We’ve seen how the Southern Initiative supports on-the-ground interventions and collaboration to influence meaningful change across communities in our region.  Expansion of the program helps achieve our shared goals by providing further access to high-quality prevention, treatment and care services in order to reduce new infections and improve quality of life for people living with HIV in the South.”

With particular focus on reducing disparities among African-American and Latino populations, the Positive Action Southern Initiative currently operates in 10 Southern states – Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Texas and Virginia.

Racial and ethnic minorities have been disproportionately affected by HIV/AIDS since the beginning of the epidemic, representing 68 percent of all new AIDS diagnoses in 2011, with new infection rates highest among African-American adults and adolescents. [iii]

These health disparities are particularly prevalent in the Southern U.S. In Georgia, 55 percent of new HIV diagnoses were among African Americans in 2012, despite comprising only 31 percent of the population in the state.[iv],[v]  In Louisiana, 69 percent of newly diagnosed HIV cases and 74 percent of newly diagnosed AIDS cases were among African Americans in 2013, though African Americans make up only 32 percent of Louisiana’s overall population.[vi]  In Mississippi, where the highest rate of HIV infections were among African Americans and Hispanics (37 and 13 per 100,000 persons, respectively), African Americans accounted for 75 percent of newly reported HIV infections in 2012, and their rate of infection was six times higher than the rate among Whites.[vii]

About ViiV Healthcare’s Positive Action Program The Southern Initiative is part of ViiV Healthcare’s broader Positive Action program that has empowered community organizations in Africa, Europe, Latin America and Asia over the past 22 years. As a company focused solely on HIV/AIDS, ViiV Healthcare is committed to building on the success of the global program with efforts to support projects in the United States that address areas of greatest need.

When Positive Action was created in 1992 it was the first pharmaceutical company program of its kind to support communities affected by HIV and AIDS. The program targets its funds towards community-focused projects that reach those most affected by HIV, particularly in marginalized or vulnerable populations. These include youth, women and girls, sex workers, injection drug users, MSM, the incarcerated, transgender individuals and gay men. Positive Action works to build capacity in these communities to enable them to tackle stigma and discrimination, to test innovations in education, care and treatment, and to deliver greater and meaningful involvement of people living with HIV.

For more information about Positive Action, please visit: http://www.viivhealthcare.com/community-partnerships/positive-action/about.aspx

 

About ViiV Healthcare  

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

[i] Gardner EM, McLees, MP, Steiner JF, del Reio, C.  The Spectrum of Engagement in HIV Care and its Relevance to Test-and-Treat Strategies for Prevention of HIV Infection. Clin Infect Dis. 2011; 52 (6): 793-800. 

[ii] Centers for Disease Control and Prevention. HIV and AIDS in the United States by Geographic Distribution. http://www.cdc.gov/hiv/resources/factsheets/geographic.htm.  Accessed August 26, 2014.

[iii] Centers for Disease Control and Prevention. HIV Surveillance by Race/Ethnicity (through 2011). http://www.cdc.gov/hiv/pdf/statistics_surveillance_raceEthnicity.pdf. Accessed August 26, 2014.

[iv] The Georgia Department of Public Health.  Fact Sheet: HIV Surveillance, Georgia, 2012. http://dph.georgia.gov/sites/dph.georgia.gov/files/HIV_EPI_Fact_Sheet_Surveillance_2012.pdf.  Accessed September 18, 2014.

[v] United States Census Bureau.  State & County Quick Facts. Georgia. http://quickfacts.census.gov/qfd/states/13000.html.  Accessed September 18, 2014.

[vi] Louisiana Department of Health and Hospitals, Office of Public Health, STD/HIV Program (SHP). Louisiana HIV/AIDS Surveillance Quarterly Report, June 30, 2014. http://www.dhh.louisiana.gov/assets/oph/HIVSTD/hiv-aids/2014/Second_Quarter2014.pdf.  Accessed September 18, 2014.

[vii] Mississippi State Department of Health. HIV Disease 2012 Fact Sheet.  http://msdh.ms.gov/msdhsite/_static/resources/5070.pdf.  Accessed September 18, 2014.

U.S. Media Inquiries Marc Meachem (919) 483-8756
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cms_img_triumeq_packagingLondon, UK, 22 August, 2014 – ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq® (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.1 Triumeq is ViiV Healthcare’s first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen  that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.

Triumeq alone is not recommended for use in patients with current or past history of resistance to any components of Triumeq. Triumeq alone is not recommended in patients with resistance-associated integrase substitutions or clinically suspected INSTI resistance because the dose of dolutegravir in Triumeq is insufficient in these populations. Before initiating treatment with abacavir-containing products, screening for the presence of a genetic marker, the HLA-B*5701 allele, should be performed in any HIV-infected patient, irrespective of racial origin. Products containing abacavir should not be used in patients known to carry the HLA-B*5701 allele.1

Dr Dominique Limet, Chief Executive Officer, ViiV Healthcare, said: “Today’s approval of Triumeq offers many people living with HIV in the US the first single-pill regimen containing dolutegravir. ViiV Healthcare is committed to delivering advances in care and new treatment options to physicians and people living with HIV. We are proud to announce this important milestone, marking the second new treatment to be approved in the US from our pipeline of medicines.”

This FDA approval is based primarily upon data from two clinical trials:

  • the Phase III study (SINGLE) of treatment-naïve adults, conducted with dolutegravir and abacavir/lamivudine as separate pills2,3
  • a bioequivalence study of the fixed-dose combination of abacavir, dolutegravir and lamivudine when taken as a single pill compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.4

In the SINGLE study, a non-inferiority trial with a pre-specified superiority analysis, more patients were undetectable (HIV-1 RNA <50 copies/mL) in the dolutegravir and abacavir/lamivudine arm (the separate components of Triumeq) than in the Atripla®†(efavirenz, emtricitabine and tenofovir) arm, the most commonly used single-pill regimen. The difference was statistically significant and met the pre-specified test for superiority. The difference was driven by a higher rate of discontinuation due to adverse events in the Atripla arm.2, 3

  • At 96 weeks, 80% of participants on the dolutegravir-based regimen were virologically suppressed compared to 72% of participants on Atripla. Grade 2-4 treatment emergent adverse reactions occurring in 2% or more participants taking the dolutegavir-based regimen were insomnia (3%), headache (2%) and fatigue (2%).3

About HIV

HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life.5-7

HIV infects specific cells of the immune system, called CD4 cells or T-cells. Over time, HIV can destroy so many of these cells that the body cannot fight off infections and disease. When this happens, HIV infection leads to Acquired Immunodeficiency Syndrome (AIDS) which is the final stage of HIV infection. There is no cure for HIV, but with early diagnosis and effective treatment most people with HIV will not go on to develop AIDS.5-7

An estimated 1.1 million people in the US are living with HIV.However, only 33 percent are taking the medication they need.8

About Triumeq

Triumeq is a fixed-dose combination containing the INSTI dolutegravir and the NRTIs abacavir and lamivudine. 

Two essential steps in the HIV life cycle are replication – when the virus turns its RNA copy into DNA – and integration – the moment when viral DNA becomes part of the host cell’s DNA. These processes require two enzymes called reverse transcriptase and integrase. NRTIs and integrase inhibitors interfere with the action of the two enzymes to prevent the virus from replicating and further infecting cells. 

Dolutegravir was approved in the US in August 2013 and in Europe in January 2014 under the brand name Tivicay®. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion on the Marketing Authorisation Application (MAA) for Triumeq on 26 June 2014. Regulatory applications are also being evaluated in other markets worldwide, including Australia, Brazil and Canada.

Tivicay and Triumeq are registered trademarks of the ViiV Healthcare group of companies.

 

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined as a shareholder in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.