ViiV Healthcare declares constructive information demonstrating 2-drug routine DOVATO is as efficient as 3-drug routine BIKTARVY for upkeep remedy of HIV-1
- Largest head-to-head randomized medical trial between DTG/3TC and BIC/FTC/TAF, carried out by SEIMC-GeSIDA Basis (FSG) confirmed DTG/3TC demonstrated non-inferior efficacy in comparison with BIC/FTC/TAF as a swap routine for virologically-suppressed adults dwelling with HIV over 48 weeks of remedy.
- DTG/3TC-treated people had considerably much less weight achieve in comparison with these randomized to BIC/FTC/TAF.
- In 2022, the Canadian HIV incidence price grew by 15% compared to 2020, a complete of 1,848 new circumstances. 1
- In response to the most recent surveyed information, there’s an estimated 65,270 Canadians dwelling with HIV. 1
MONTREAL, July 31, 2024 /CNW/ – ViiV Healthcare, the worldwide specialist HIV firm majority owned by GSK, with Pfizer and Shionogi as shareholders, introduced the 48-week findings from PASO DOBLE (GeSIDA 11720 examine), the most important head-to-head, part IV randomized medical trial (RCT) investigating the 2-drug routine DOVATO (dolutegravir/lamivudine [DTG/[3TC]) in comparison with the 3-drug routine BIKTARVY (bictegravir/emtricitabine]/tenofovir alafenamide fumarate [BIC/FTC/TAF]) for the therapy of HIV-1 in people who find themselves virologically suppressed and who may gain advantage from therapy optimization.2
Findings confirmed that switching to DTG/3TC in virologically suppressed adults dwelling with HIV demonstrated non-inferior efficacy in sustaining viral suppression in contrast with switching to BIC/FTC/TAF.3 This information was lately introduced on the 25th Worldwide AIDS Convention (AIDS 2024), in Munich, Germany.
Concord P. Garges, M.D., MPH, Chief Medical Officer at ViiV Healthcare, stated: “The outcomes from PASO DOBLE present that Dovato demonstrated non-inferior efficacy in comparison with Biktarvy, and that the typical weight achieve for trial individuals taking DTG/3TC was considerably decrease than these taking BIC/FTC/TAF over the course of the 12 months. This can be a significant end result, as treatment-related weight achieve is a crucial matter for many individuals dwelling with HIV. At ViiV Healthcare we’re devoted to bringing revolutionary HIV remedies to folks dwelling with HIV that aren’t solely secure and efficient, but in addition tackle their particular wants past viral suppression.”
Jean-Francois Fortin, Nation Medical Director, Canada at ViiV Healthcare, stated: “With a number of choices accessible for the therapy of HIV, it’s our duty to additional examine and monitor accessible therapies to make sure that Canadians dwelling with HIV are receiving the very best care. We’re excited to see that the outcomes from PASO DOBLE present that Dovato, a 2-drug routine, gives comparable efficacy, in addition to much less weight achieve in comparison with BIC/FTC/TAF via 48 weeks. At ViiV Healthcare Canada, our dedication is to supply HIV remedies that tackle the varied wants of individuals dwelling with HIV, which begins with acquiring viral suppression.”
Within the PASO DOBLE medical trial, 553 folks dwelling with HIV and virally suppressed switched therapy to both DTG/3TC (n=277) or BIC/FTC/TAF (n=276). The examine inhabitants included people who had been on remedy that might be optimized, corresponding to a number of pill regimens, or these containing pharmacokinetic boosting brokers or medicine with cumulative toxicity, corresponding to efavirenz or tenofovir disoproxil fumarate (TDF).3 The examine met its major endpoint when DTG/3TC demonstrated non-inferior efficacy versus BIC/FTC/TAF based mostly on the proportion of individuals with viral RNA ≥50 copies/mL at 48 weeks utilizing the FDA snapshot and a 4% non-inferiority margin within the uncovered intention-to-treat inhabitants.3
At 48 weeks, DTG/3TC was non-inferior to BIC/FTC/TAF (danger distinction between DTG/3TC [2.2%] minus BIC/FTC/TAF [0.7%] of 1.4%, 95% CI -0.5 to three.4). One participant within the BIC/FTC/TAF arm and 0 within the DTG/3TC arm had protocol-defined confirmed virological failure via week 48 (HIV-1 RNA ≥50 c/mL adopted by a second consecutive HIV-1 RNA evaluation ≥200 c/mL).3
The examine discovered that weight elevated considerably extra in individuals who switched to BIC/FTC/TAF (adjusted imply change 1.81kg, 95% CI 1.28-2.34) than in those that switched to DTG/3TC (adjusted imply change 0.89kg, 95% CI 0.37-1.41) [difference 0.92kg, 95% CI 0.17-1.66] via week 48. Equally, the proportion of individuals with weight achieve larger than 5% at week 48 was considerably greater at 29.9% for BIC/FTC/TAF in comparison with 20% for DTG/3TC (adjusted OR 1.81, 95% CI 1.19-2.76).3
Weight change with DTG/3TC didn’t differ between women and men or based mostly on the earlier routine of individuals, whereas the proportion of trial individuals experiencing larger than 5% weight achieve with BIC/FTC/TAF was roughly 45% greater than these taking DTG/3TC when switching from a routine with abacavir (30.6% BIC/FTC/TAF vs 21.1% DTG/3TC), and about 2-fold greater when switching from a routine with TDF (40.7% BIC/FTC/TAF vs 19.5% DTG/3TC). Security was comparable via week 48 and per recognized security profiles. There have been few discontinuations because of antagonistic occasions in each examine arms (DTG/3TC = 1, 0.4%; BIC/FTC/TAF = 2, 0.7%), with no variations between arms.3
About PASO DOBLE
The PASO DOBLE (NCT04884139) randomized medical trial is a part IV, open-label, randomized multicentre medical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the upkeep of virologic suppression in folks dwelling with HIV-1, carried out in 30 websites throughout Spain. Virologically suppressed folks dwelling with HIV on regimens containing ≥1 capsule/day, boosters, or medicine with cumulative toxicity corresponding to efavirenz or TDF had been eligible and had been randomized (1:1) to modify to both DTG/3TC or BIC/FTC/TAF. The first endpoint was the proportion of individuals dwelling with HIV with RNA ≥50 copies/mL at 48 weeks (FDA snapshot, 4% non-inferiority margin) within the intention-to-treat uncovered inhabitants. Secondary outcomes measured included, amongst others, absolute weight achieve, BMI change, and the proportion of individuals with weight change larger than 5%.3
About DOVATO
DOVATO is indicated as an entire routine for the therapy of Human Immunodeficiency Virus sort 1 (HIV-1) an infection in adults and adolescents 12 years of age and older and weighing at the very least 40 kg.3
DOVATO is accredited in Canada, US, Europe, Japan, Australia, and different international locations worldwide.
Please seek the advice of the Product Monograph at www.viivhealthcare.ca for full security data. The Product Monograph can be accessible by calling 1-877-393-8448.
About SEIMC-GeSIDA Basis (FSG)
The SEIMC-GeSIDA Basis (FSG) was created to encourage, promote, and assist scientific and technical analysis and improvement, coaching, and publication of findings within the area of medical microbiology and infectious ailments and related circumstances. FSG was based by investigators from the Spanish Society of Medical Microbiology and Infectious Ailments as a instrument to advertise high-quality investigation within the area of HIV an infection and different infectious ailments. The Basis additionally goals to reply to the scientific issues of the group’s members.
FSG consists of certified professionals with expertise within the area of medical trials and multicenter research. Its streamlined infrastructure facilitates efficiency of medical research and responds to the wants of investigators when it comes to methodology/statistical evaluation and of logistics and administration of trials and different multicenter research. FSG additionally offers employees to run occasions corresponding to scientific conferences and conferences (nationwide and worldwide) and to prepare programs, lectures, talks, seminars, round-table talks, and specialised workshops.
For extra data on the FSG, please go to https://fundacionseimcgesida.org/en/quienes-somos/
About HIV
HIV (human immunodeficiency virus) is a virus that assaults the physique’s immune system.4 HIV is unfold by contact with sure bodily fluids of an individual with HIV, mostly throughout unprotected intercourse (intercourse and not using a condom or HIV medication to stop or deal with HIV), or via sharing injected drug gear.5
If HIV isn’t handled, it may well result in AIDS (acquired immunodeficiency virus). AIDS is probably the most extreme stage of HIV (Stage 3).5 There may be at the moment no treatment for HIV, however with correct therapy and care, folks with HIV can keep a top quality of life and keep away from passing HIV to others.
On the finish of 2022, 39 million folks lived with HIV all over the world, with 1.3 million new diagnoses that 12 months and 630,000 deaths from AIDS-related sicknesses.6
About ViiV Healthcare
ViiV Healthcare is a worldwide specialist HIV firm established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) devoted to delivering advances in therapy and look after folks dwelling with HIV and for people who find themselves prone to buying HIV. Shionogi turned a ViiV shareholder in October 2012. The corporate’s goals are to take a deeper and broader curiosity in HIV and AIDS than any firm has achieved earlier than and take a brand new method to ship efficient and revolutionary medicines for HIV therapy and prevention, in addition to assist communities affected by HIV.
For extra data on the corporate, its administration, portfolio, pipeline, and dedication, please go to www.viivhealthcare.ca.
SOURCE ViiV Healthcare
