ViiV Has Successful Phase 3 Data at AIDS 2018 from Landmark Studies

GEMINI 1 & 2 studies meet primary endpoint, showing two-drug
regimen to be effective across high and low viral loads

ViiV Healthcare today presented at the 22^nd International
AIDS conference in Amsterdam 48-week results from the phase III GEMINI 1
& 2 studies, assessing the safety and efficacy of a two-drug regimen
(2DR) of dolutegravir (DTG) and lamivudine (3TC) compared to a
three-drug regimen of dolutegravir and two nucleoside reverse
transcriptase inhibitors (NRTIs), tenofovir disoproxil
fumarate/emtricitabine (TDF/FTC), in treatment-naïve, HIV-1 infected
adults with baseline viral loads up to 500,000 copies per millilitre
(c/mL).

The studies met their primary endpoint for non-inferiority based on
plasma HIV-1 RNA <50c/mL, a standard measure of HIV control, at Week 48.
In a pooled analysis, 91% (655/716) of patients taking DTG + 3TC had
HIV-1 RNA <50 copies/mL compared with 93% (669/717) of patients taking
DTG +TDF/FTC [adjusted difference -1.7% (95% CI: -4.4%, 1.1%)].¹

Pedro Cahn, principal investigator for the GEMINI study programme said:
“For the last 15-20 years, the standard of care for HIV has revolved
around three-drug regimens. Now that we have more potent drugs, the
focus is shifting to tolerability and convenience. The GEMINI studies
show that we can get the efficacy of three drugs in a two-drug regimen
with the tolerability and drug interaction profile of DTG and 3TC. These
are important findings for people living with HIV who will spend their
lifetime taking drugs to suppress their virus. The studies have the
potential to expand the treatment paradigm for first-line therapy of
people living with HIV.”

Results show broadly consistent results for virus suppression across
individuals with higher viral load (more than 100,000 copies of viral
RNA per millilitre of blood plasma [>100,000 c/mL]) and lower viral load
(<=100,000 c/mL) HIV-1 plasma RNA. Rates of virologic failure were ≤1%
across all arms of the study. No patient who experienced virologic
failure in either treatment arm developed treatment-emergent resistance.¹

The percentage of patients that withdrew due to adverse events was 2% in
each study arm (GEMINI 1 DTG + 3TC arm n=7, GEMINI 1 DTG + TDF/FTC arm
n=8, GEMINI 2 DTG + 3TC arm n= 8, GEMINI 2 DTG + TDF/FTC arm n=8).
Pooled results show that the most common (≥5%) adverse events across the
studies were headache, diarrhoea and nasopharyngitis in both arms (DTG +
3TC arm: 10%, 9%, and 8%, respectively, DTG + TDF/FTC: 10%, 11%, and
11%, respectively).¹

Drug-related adverse events were less frequent in patients on the
DTG/3TC regimen (126/716, 18%), compared with those on the DTG + TDF/FTC
regimen (169/717, 24%).¹

John C. Pottage, Jr., MD, Chief Scientific and Medical Officer of ViiV
Healthcare, said: “These data we have presented at AIDS 2018 provide
further evidence that we should be rethinking the traditional approach
to HIV treatment of using three or more drugs. The results from the
GEMINI programme support our belief that the two-drug regimen of
dolutegravir and lamivudine can be a valuable option for treatment-naïve
patients and that no patient should take more medicine than they need.”

ViiV Healthcare intends to seek regulatory approval for a fixed-dose
combination of DTG and 3TC later this year. DTG and 3TC, as a 2DR, is
not yet approved for use by the US FDA.

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