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VIIV HEALTHCARE TO PRESENT NEW
LONG-TERM FINDINGS FROM ITS
INNOVATIVE 2-DRUG AND LONG-ACTING
HIV MEDICINES PORTFOLIO AT CROI 2022
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Data reinforce ViiV Healthcare's leadership and commitment to developing ground-breaking medicines for HIV treatment and prevention
London, 7 February 2022 - ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) as shareholders, today announced the presentation of company and investigator sponsored abstracts from its industry-leading HIV treatment and prevention portfolio of approved long-acting medicines and 2-drug regimens (2DRs) at the Conference on Retroviruses and Opportunistic Infections (CROI 2022), being held virtually 12-16 February.
Key data presentations will include:
• Data demonstrating further evidence for the long-acting regimen of Cabenuva1 (cabotegravir and rilpivirine) administered every two months, including ATLAS-2M 152-week efficacy and safety findings for the treatment of HIV-1 in virologically suppressed adults, which builds upon previous 96-week efficacy and safety data. An investigator-sponsored analysis of adolescent perspectives toward the long-acting regimen will also be presented.
• Data demonstrating further evidence for the 2-drug regimen Dovato (dolutegravir/lamivudine), including an analysis of long-term 144-week efficacy findings from the TANGO study, which evaluated virologic response in participants receiving dolutegravir/lamivudine versus tenofovir alafenamide (TAF) based regimens. Two abstracts will also be presented from Week 48 findings from the SALSA study that assessed the proportion of baseline participant samples with archived resistance and metabolic health findings for the 2-drug regimen.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare said: "The data to be presented at CROI includes study results of up to three years that reinforce the long-term efficacy and safety data of our long-acting medicines and 2-drug regimens. Despite the challenging environment we've faced for the last two years, ViiV Healthcare has continued to demonstrate leadership by bringing forward ground-breaking advances that offer people more options for HIV treatment and prevention. We look forward to sharing our latest findings with the HIV community at CROI 2022."
Key abstracts to be presented at CROI 2022 by ViiV Healthcare and study partners will include:
ATLAS-2M 152-week efficacy and safety findings for long-acting cabotegravir and rilpivirine administered every two months for the treatment of HIV-1 in virologically suppressed adults: The ATLAS-2M study was designed to assess the non-inferiority and safety of long-acting cabotegravir and rilpivirine administered every two months compared to monthly administration for the treatment of HIV-1. Findings to be presented at CROI 2022 provide long-term outcomes for cabotegravir and rilpivirine as a complete regimen for the maintenance of HIV-1 virologic suppression.2
Adolescent and Parent Experiences with Long-Acting Injectables in the MOCHA study (Investigator sponsored): The ongoing More Options for Children and Adolescents Study (MOCHA) was designed to examine the use of long-acting cabotegravir and rilpivirine injections in adolescents living with HIV-1. Findings from Cohort 1 of MOCHA to be presented at CROI 2022 provide qualitative and quantitative insights into participant experiences and perceptions around acceptability of the long-acting regimen.3
Low-level HIV replication for dolutegravir/lamivudine vs TAF-based regimens in the TANGO study: The TANGO study was designed to assess the antiviral efficacy and safety of switching to a 2DR consisting of dolutegravir/lamivudine in adults living with HIV-1 who are virologically suppressed and stable on a TAF-based regimen. Findings to be presented at CROI 2022 include longer-term data analysing the proportions of participants with viral load (VL) <40 c/mL and Target Not Detected (TND) status by visit (Snapshot) through Week 144.4
Post-hoc analyses evaluating archived resistance and response to dolutegravir/lamivudine, and metabolic health data, in the SALSA study: The SALSA study was set up to assess the antiviral efficacy and safety of switching to a 2DR consisting of dolutegravir/lamivudine in adults living with HIV-1 who are virologically suppressed on a current antiretroviral regimen (CAR) consisting of at least three drugs (including two nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent). Findings to be presented at CROI 2022 include data assessing the proportion of baseline participant samples with archived resistance, and virologic response through 48 weeks using the stringent VL measure <40 c/mL and TND, as well as metabolic health data.
In addition to these studies assessing ViiV Healthcare's long-acting and 2-drug HIV treatment regimens, the HIV Prevention Trials Network (HPTN) will present new data from four abstracts related to cabotegravir long-acting for PrEP from the HPTN 083 and 084 studies. Data from the HPTN studies, which were among the most diverse and comprehensive HIV prevention trial programs to date, will include updated efficacy, safety and case studies for cabotegravir long-acting for PrEP from HPTN 083; an evaluation of safety and pharmacokinetics in pregnant women from HPTN 084; findings on the early detection of HIV infection and the impact on integrase strand transfer inhibitor (INSTI) resistance risk when taking cabotegravir long-acting for PrEP; and a counterfactual estimation of the efficacy of cabotegravir long-acting for PrEP against placebo using external trial data.
The full list of ViiV Healthcare data and investigator sponsored studies to be presented at CROI 2022 is outlined below:
Important Safety Information for Dovato (50mg dolutegravir/300mg lamivudine) Tablets
INDICATION
Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV
All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating Dovato. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If Dovato is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.
Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of Dovato. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.
Contraindications
• Do not use Dovato in patients with previous hypersensitivity reaction to dolutegravir or lamivudine
• Do not use Dovato in patients receiving dofetilide
Warnings and precautions
Click link for full announcemet
https://us.gsk.com/en-us/media/press-releases/viiv-healthcare-to-present-new-long-term-findings-from-its-innovative-2-drug-and-long-acting-hiv-medicines-portfolio-at-croi-2022/
For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.
References
1. Approved as Vocabria and Rekambys by the European Medicines Agency
2. Overton E, Richmond G, Rizzardini G, et al., Long-acting cabotegravir + rilpivirine every 2 months: ATLAS-2M Week 152 results. Presented at Conference on Retroviruses and Opportunistic Infections (CROI) February 2022.
3. Lowenthal E, Chapman J, Calabrese K, et al., Adolescent and parent experiences with long-acting injectables in the MOCHA study. Presented at Conference on Retroviruses and Opportunistic Infections (CROI) February 2022.
4. Wang R, George N, Ait-Khaled M, et al., Low-level HIV replication for DTG/3TC vs TAF-Based Regimen in TANGO through Week 144
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