Gilead’s Sovaldi® Demonstrates Efficacy and Safety Among Chronic Hepatitis C
Patients with Advanced Liver Disease
-- Benefit in Patients with Decompensated Cirrhosis and Recurrent HCV
Infection Following Liver Transplantation --
The International Liver Congress 2014
LONDON -- April 11, 2014
Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from two Phase 2
studies and a compassionate access study in which a regimen containing
once-daily Sovaldi^® (sofosbuvir) 400 mg was administered for the treatment of
chronic hepatitis C virus (HCV) infection in patients with advanced liver
disease. These data are being presented this week at the 49th Annual Meeting
of the European Association for the Study of the Liver (The International
Liver Congress 2014) in London.
The first study, Study GS-US-334-0125 (Oral #068), is an ongoing open-label
Phase 2 clinical trial evaluating HCV patients with cirrhosis and portal
hypertension, with or without decompensation, who were randomized 1:1 to an
immediate treatment arm in which Sovaldi and ribavirin (RBV) was administered
for 48 weeks (n=25) or to a deferred treatment arm in which this regimen was
initiated after a 24-week observation period (n=25). Eighty percent of
participants were treatment-experienced.
Of the 22 patients who completed 24 weeks of therapy, 95 percent (n=21/22)
achieved virologic suppression on treatment. Additionally, patients taking
Sovaldi-based therapy experienced trends in clinical and laboratory parameter
improvements compared to patients in the observation arm. Sovaldi-based
therapy was well tolerated in the study, and only one patient discontinued
treatment due to an adverse event. The most common adverse events occurring in
more than 25 percent of patients included nausea and pruritis. Patients in
both arms of the study will be followed to determine their 12-week sustained
virologic response rates (SVR12) after 48 weeks of Sovaldi-based therapy.
Study GS-US-334-0126 (Poster #1232), was a single-arm open-label Phase 2 trial
in which patients with established recurrent HCV infection following liver
transplantation received up to 24 weeks of therapy with Sovaldi plus RBV
(escalating doses starting at 400 mg/day). The majority of patients had
genotype 1-HCV infection (n=33/40) and 88 percent (n=35/40) were
Seventy percent (n=28/40) of patients in this study achieved SVR12. The most
common adverse events occurring in more than 20 percent of patients were
fatigue, headache, arthralgia (joint pain) and diarrhea. There were no deaths,
graft losses or episodes of organ rejection among post-liver transplantation
patients, and no drug-drug interactions were reported between Sovaldi and
A third, compassionate access study (Oral #62), evaluated Sovaldi therapy
among 104 post-transplant patients with severe recurrent HCV, including
fibrosing cholestatic hepatitis, who had exhausted all other treatment options
and received pre-approval access to Sovaldi via Gilead’s compassionate use
program. Patients received up to 48 weeks of Sovaldi plus RBV, with some
patients also receiving pegylated interferon (peg-IFN) (180 μg/week) at their
physician’s discretion. The majority of patients in the study experienced
clinical improvements on treatment. Overall, 62 percent of patients achieved
SVR12. Sovaldi-based therapy was well tolerated.
“The patients included in these analyses are historically among the most
difficult to cure, and many have had no appropriate treatment options until
now,” said Norbert Bischofberger, PhD, Executive Vice President of Research
and Development and Chief Scientific Officer, Gilead Sciences. “These data
demonstrate that Sovaldi-based oral therapy can improve outcomes, has a
favorable safety profile and is well tolerated among hepatitis C patients with
severe liver disease.”
Additional information about Study GS-US-334-0125 and Study GS-US-334-0126 can
be found at www.clinicaltrials.gov.
Sovaldi is an oral nucleotide analog inhibitor of the HCV NS5B polymerase
enzyme, which plays an essential role in HCV replication. Sovaldi is a
direct-acting agent, meaning that it interferes directly with the HCV life
cycle by suppressing viral replication.
Sovaldi ^ was approved in the United States on December 8, 2013 and in the
European Union on January 17. In the United States, Sovaldi is approved for
the treatment of chronic hepatitis C infection as a component of a combination
antiviral treatment regimen. Efficacy has been established in subjects with
HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular
carcinoma meeting Milan criteria (awaiting liver transplantation) and those
with HCV/HIV-1 co-infection. Treatment response varies based on baseline host
and viral factors. Monotherapy is not recommended for treatment of chronic
hepatitis C. Studies GS-US-334-0125 and GS-US-334-0126 evaluated
investigational uses of Sovaldi, for which safety and efficacy have not yet
IMPORTANT SAFETY INFORMATION
Sovaldi combination treatment with ribavirin or with peginterferon alfa plus
ribavirin is contraindicated in women who are pregnant or may become pregnant
and men whose female partners are pregnant because of the risk for birth
defects and fetal death associated with ribavirin. Contraindications to
peginterferon alfa and ribavirin also apply to Sovaldi combination treatment.
Refer to the prescribing information of peginterferon alfa and ribavirin for a
list of their contraindications.
Warnings and Precautions
*Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin: Ribavirin
therapy should not be started unless a report of a negative pregnancy test
has been obtained immediately prior to initiation of therapy. Female
patients of childbearing potential and their male partners must use two
forms of non-hormonal contraception during treatment and for at least 6
months after treatment has concluded. Routine monthly pregnancy tests must
be performed during this time. Refer to the prescribing information for
*Use with Potent P-gp Inducers: Rifampin and St. John’s wort should not be
used with Sovaldi as they may significantly decrease sofosbuvir plasma
concentration, reducing its therapeutic effect.
Most common (≥20 percent, all grades) adverse reactions for:
*Sovaldi + peginterferon alfa + ribavirin combination therapy were fatigue,
headache, nausea, insomnia, and anemia
*Sovaldi + ribavirin combination therapy were fatigue, and headache
In addition to rifampin and St. John’s wort, coadministration of Sovaldi is
not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin,
rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is
expected to decrease the concentration of sofosbuvir, reducing its therapeutic
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and
commercializes innovative therapeutics in areas of unmet medical need. The
company’s mission is to advance the care of patients suffering from
life-threatening diseases worldwide. Headquartered in Foster City, California,
Gilead has operations in North and South America, Europe and Asia Pacific.
This press release includes forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 that are subject to
risks, uncertainties and other factors, including the possibility of
unfavorable longer-term results from clinical trials evaluating Sovaldi for
the treatment of HCV among patients with advanced liver disease, and the risk
that healthcare providers, payers or insurers may not recognize the benefits
of Sovaldi over other agents. As Sovaldi is used over longer periods of time
by treatment-experienced patients with underlying health problems taking
numerous other medicines, Gilead may find new issues such as safety,
resistance or drug interaction issues, which may require it to provide
additional warnings or contraindications in the label, which could reduce the
market acceptance of Sovaldi. These risks, uncertainties and other factors
could cause actual results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in detail in
Gilead’s Annual Report on Form 10-K for the year ended December 31, 2013, as
filed with the U.S. Securities and Exchange Commission. All forward-looking
statements are based on information currently available to Gilead, and Gilead
assumes no obligation to update any such forward-looking statements.
U.S. full prescribing information for Sovaldi is available at www.gilead.com.
Sovaldi is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company’s website at
www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead
Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936 (Investors)
Cara Miller, +1 650-522-1616 (Media (U.S.))
Arran Attridge, +44 208 587 2477 (Media (Europe))
Press spacebar to pause and continue. Press esc to stop.