Dec 19 (Reuters) - Merck's ( MRK ) experimental two-drug
combination met the main goal of significantly suppressing
replication of the HIV-1 virus in adults receiving another form
of therapy in two late-stage studies, the company said on
Thursday.
The U.S. drugmaker is seeking new growth drivers to offset a
potential hit from its blockbuster cancer immunotherapy Keytruda
losing patent protection toward the end of the decade.
Merck ( MRK ) was testing a combination of doravirine and islatravir
across the trials involving more than 1,000 patients.
In one of the studies, Merck's ( MRK ) combination was shown to be
safe and "non-inferior" to Gilead Sciences' ( GILD ) top-selling
HIV drug Biktarvy.
However, the treatment was not superior to Biktarvy in
suppressing the replication of HIV-1, the most common strain of
the virus, in the same study, which enrolled patients who were
already receiving Gilead's drug.
These patients were randomly chosen to either switch to
Merck's ( MRK ) treatment or continue on Biktarvy.
In both the studies, Merck ( MRK ) was testing its combination in
patients who were already on antiretroviral therapy, which stops
the virus from reproducing in the body.
Doravirine, branded as Pifeltro, is approved in combination
with other antiretrovirals to treat adults with HIV-1 infection
with no history of treatment failure or resistance to the drug.
It is also approved under the brand name Delstrigo as a
single, complete regimen for the treatment of these patients.
The label for doravirine carries a boxed warning, the health
regulator's strictest, to flag the risk of worsening hepatitis B
infection.
Merck's ( MRK ) combination also helped suppress viral replication
in adults compared to other antiretroviral therapy in a separate
open-label late-stage study.
The company plans to file the data with regulatory
authorities and present detailed findings at a medical meeting.