- Largest head-to-head randomized clinical trial
between DTG/3TC and BIC/FTC/TAF, conducted by
SEIMC-GeSIDA Foundation (FSG) showed DTG/3TC
demonstrated non-inferior efficacy compared to BIC/FTC/TAF as a switch regimen for
virologically-suppressed adults living with HIV over 48 weeks of
therapy.
- DTG/3TC-treated individuals had significantly less weight
gain compared to those randomized to BIC/FTC/TAF.
- In 2022, the Canadian HIV incidence rate grew by 15% in
comparison to 2020, a total of 1,848 new cases.
1
- According to the latest surveyed data, there is an
estimated 65,270 Canadians living with
HIV. 1
MONTREAL, July 31,
2024 /CNW/ - ViiV Healthcare, the global specialist
HIV company majority owned by GSK, with Pfizer and Shionogi as
shareholders, announced the 48-week findings from PASO DOBLE
(GeSIDA 11720 study), the largest head-to-head, phase IV randomized
clinical trial (RCT) investigating the 2-drug regimen DOVATO
(dolutegravir/lamivudine [DTG/[3TC]) compared to the 3-drug regimen
BIKTARVY (bictegravir/emtricitabine]/tenofovir alafenamide fumarate
[BIC/FTC/TAF]) for the treatment
of HIV-1 in people who are virologically suppressed and who could
benefit from treatment optimization.2
Findings showed that switching to DTG/3TC in virologically
suppressed adults living with HIV demonstrated non-inferior
efficacy in maintaining viral suppression compared with switching
to BIC/FTC/TAF.3 This data was
recently presented at the 25th International AIDS
Conference (AIDS 2024), in Munich,
Germany.
Harmony P. Garges, M.D., MPH,
Chief Medical Officer at ViiV Healthcare, said: "The
results from PASO DOBLE show that Dovato demonstrated
non-inferior efficacy compared to Biktarvy, and that the
average weight gain for trial participants taking DTG/3TC was
significantly lower than those taking BIC/FTC/TAF over the course of the year. This
is a meaningful outcome, as treatment-related weight gain is an
important topic for many people living with HIV. At ViiV Healthcare
we're dedicated to bringing innovative HIV treatments to people
living with HIV that are not only safe and effective, but also
address their specific needs beyond viral suppression."
Jean-Francois Fortin, Country
Medical Director, Canada at ViiV
Healthcare, said: "With multiple options available for
the treatment of HIV, it's our responsibility to further study and
monitor available therapies to ensure that Canadians living with
HIV are receiving the best possible care. We are excited to see
that the results from PASO DOBLE show that Dovato, a 2-drug
regimen, offers comparable efficacy, as well as less weight gain
compared to BIC/FTC/TAF through 48
weeks. At ViiV Healthcare Canada, our commitment is to provide HIV
treatments that address the various needs of people living with
HIV, which begins with obtaining viral suppression."
In the PASO DOBLE clinical trial, 553 people living with HIV and
virally suppressed switched treatment to either DTG/3TC (n=277) or
BIC/FTC/TAF (n=276). The study
population included individuals who were on therapy that could be
optimized, such as multiple tablet regimens, or those containing
pharmacokinetic boosting agents or drugs with cumulative toxicity,
such as efavirenz or tenofovir disoproxil fumarate
(TDF).3 The study met its primary endpoint when
DTG/3TC demonstrated non-inferior efficacy versus BIC/FTC/TAF based on the proportion of
participants with viral RNA ≥50 copies/mL at 48 weeks using the FDA
snapshot and a 4% non-inferiority margin in the exposed
intention-to-treat population.3
At 48 weeks, DTG/3TC was non-inferior to BIC/FTC/TAF (risk difference between DTG/3TC
[2.2%] minus BIC/FTC/TAF [0.7%] of
1.4%, 95% CI -0.5 to 3.4). One participant in the BIC/FTC/TAF arm and zero in the DTG/3TC arm
had protocol-defined confirmed virological failure through week 48
(HIV-1 RNA ≥50 c/mL followed by a second consecutive HIV-1 RNA
assessment ≥200 c/mL).3
The study found that weight increased significantly more in
participants who switched to BIC/FTC/TAF (adjusted mean change 1.81kg, 95%
CI 1.28-2.34) than in those who switched to DTG/3TC (adjusted mean
change 0.89kg, 95% CI 0.37-1.41) [difference 0.92kg, 95% CI
0.17-1.66] through week 48. Equally, the proportion of participants
with weight gain greater than 5% at week 48 was significantly
higher at 29.9% for BIC/FTC/TAF
compared to 20% for DTG/3TC (adjusted OR 1.81, 95% CI
1.19-2.76).3
Weight change with DTG/3TC did not differ between men and women
or based on the previous regimen of participants, whereas the
proportion of trial participants experiencing greater than 5%
weight gain with BIC/FTC/TAF was
approximately 45% higher than those taking DTG/3TC when switching
from a regimen with abacavir (30.6% BIC/FTC/TAF vs 21.1% DTG/3TC), and about
2-fold higher when switching from a regimen with TDF (40.7%
BIC/FTC/TAF vs 19.5% DTG/3TC).
Safety was comparable through week 48 and consistent with known
safety profiles. There were few discontinuations due to adverse
events in both study arms (DTG/3TC = 1, 0.4%; BIC/FTC/TAF = 2, 0.7%), with no differences
between arms.3
About PASO DOBLE
The PASO DOBLE (NCT04884139) randomized clinical trial is a
phase IV, open-label, randomized multicentre clinical trial
evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virologic
suppression in people living with HIV-1, conducted in 30 sites
across Spain. Virologically
suppressed people living with HIV on regimens containing ≥1
pill/day, boosters, or drugs with cumulative toxicity such as
efavirenz or TDF were eligible and were randomized (1:1) to switch
to either DTG/3TC or BIC/FTC/TAF.
The primary endpoint was the proportion of people living with HIV
with RNA ≥50 copies/mL at 48 weeks (FDA snapshot, 4%
non-inferiority margin) in the intention-to-treat exposed
population. Secondary outcomes measured included, among others,
absolute weight gain, BMI change, and the proportion of
participants with weight change greater than 5%.3
About DOVATO
DOVATO is indicated as a complete regimen for the treatment of
Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and
adolescents 12 years of age and older and weighing at least 40
kg.3
DOVATO is approved in Canada,
US, Europe, Japan, Australia, and other countries
worldwide.
Please consult the Product Monograph at www.viivhealthcare.ca
for complete safety information. The Product Monograph is also
available by calling 1-877-393-8448.
About SEIMC-GeSIDA Foundation (FSG)
The SEIMC-GeSIDA Foundation (FSG) was created to encourage,
promote, and support scientific and technical research and
development, training, and publication of findings in the field of
clinical microbiology and infectious diseases and associated
conditions. FSG was founded by investigators from the Spanish
Society of Clinical Microbiology and Infectious Diseases as a tool
to promote high-quality investigation in the field of HIV infection
and other infectious diseases. The Foundation also aims to respond
to the scientific concerns of the group's members.
FSG is composed of qualified professionals with experience in
the field of clinical trials and multicenter studies. Its
streamlined infrastructure facilitates performance of clinical
studies and responds to the needs of investigators in terms of
methodology/statistical analysis and of logistics and management of
trials and other multicenter studies. FSG also provides staff to
run events such as scientific meetings and conferences (national
and international) and to organize courses, lectures, talks,
seminars, round-table talks, and specialized workshops.
For more information on the FSG, please visit
https://fundacionseimcgesida.org/en/quienes-somos/
About HIV
HIV (human immunodeficiency virus) is a virus that attacks the
body's immune system.4 HIV is spread by contact with
certain bodily fluids of a person with HIV, most commonly during
unprotected sex (sex without a condom or HIV medicine to prevent or
treat HIV), or through sharing injected drug
equipment.5
If HIV is not treated, it can lead to AIDS (acquired
immunodeficiency virus). AIDS is the most severe stage of HIV
(Stage 3).5 There is currently no cure for HIV, but
with proper treatment and care, people with HIV can maintain a high
quality of life and avoid passing HIV to others.
At the end of 2022, 39 million people lived with HIV around the
world, with 1.3 million new diagnoses that year and 630,000 deaths
from AIDS-related illnesses.6
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established
in November 2009 by GSK (LSE: GSK)
and Pfizer (NYSE: PFE) dedicated to delivering advances in
treatment and care for people living with HIV and for people who
are at risk of acquiring HIV. Shionogi became a ViiV shareholder in
October 2012. The company's aims are
to take a deeper and broader interest in HIV and AIDS than any
company has done before and take a new approach to deliver
effective and innovative medicines for HIV treatment and
prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio,
pipeline, and commitment, please visit www.viivhealthcare.ca.
_______________________________
|
1 Government
of Canada. Canada's progress towards ending the HIV epidemic.
Sourced from
https://www.canada.ca/en/public-health/services/publications/diseases-conditions/canada-progress-towards-ending-hiv-epidemic.html.
July 2024.
|
2 P.
Ryan, et al. Non-inferior efficacy and less weight gain when
switching to DTG/3TC than when switching to BIC/FTC/TAF in
virologically suppressed people with HIV (PWH): the PASODOBLE
(GeSIDA 11720) randomised clinical trial. Presented at the 25th
International AIDS Conference. July 2024
|
3 DOVATO
Product Monograph (2023). Available at:
www.viivhealthcare.ca
|
4 CDC. About
HIV. Available at:
https://www.cdc.gov/hiv/about/?CDC_AAref_Val=https://www.cdc.gov/hiv/basics/whatishiv.html
|
5 HIV.gov.
What Are HIV and AIDS? Available at:
https://www.hiv.gov/hiv-basics/overview/about-hiv-and-aids/what-are-hiv-and-aids/.
|
6 UNAIDS. Global HIV & AIDS
Statistics – Fact sheet. Available at:
https://www.unaids.org/en/resources/fact-sheet
|
SOURCE ViiV Healthcare