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|Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®|
– Results Presented at The Liver Meeting® 2017–
Positive results from studies of Harvoni® (ledipasvir
90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal
impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in
HCV-infected liver transplant recipients and Vosevi®
(sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in
NS5A-inhibitor experienced HCV-infected patients will be presented
during poster sessions on
“Gilead continues to study the effectiveness of our once-daily
sofosbuvir-based single tablet regimens in diverse chronic HCV-infected
patient populations to provide the opportunity for cure for all patient
populations, including those most difficult to cure,” said
Harvoni, Epclusa and Vosevi have Boxed Warnings in their product labels regarding the risk of hepatitis B virus reactivation in HCV/HBV coinfected patients, and Vemlidy has a Boxed Warning regarding the risk of post-treatment severe acute exacerbation of hepatitis B. See below for important safety information for all products.
Harvoni in Renally Impaired Patients (Poster #1587)
In an open-label Phase 2 study evaluating once-daily Harvoni for 12 weeks among HCV genotype 1 patients with severe renal impairment (creatinine clearance ≤ 30 mL/min), 100 percent (18/18) of patients achieved SVR12, including patients with compensated cirrhosis (n=2) and those who had failed prior treatment (n=4).
Safety events were consistent with those expected for the patient population. The most common adverse events (AEs) (>15 percent) were fatigue (22 percent), headache (22 percent) and hyperkalemia (17 percent). Four patients (22 percent) reported serious AEs, none of which was related to study drug. There were no deaths and no patients discontinued treatment in the study.
Harvoni is approved for adults with chronic HCV genotype 1, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis, adults with genotype 1 infection with decompensated cirrhosis in combination with ribavirin (RBV), and adults with genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with RBV. The safety and efficacy of Harvoni have not been established in patients with severe renal impairment.
Epclusa in Liver Transplant Patients (Poster #1069)
In an open-label Phase 2 study evaluating once-daily Epclusa for 12 weeks among 79 liver transplant patients with genotype 1-4 chronic HCV infection, treatment with Epclusa resulted in an overall SVR12 rate of 96 percent, including patients with cirrhosis and prior treatment failure, and was well tolerated.
Baseline resistance mutations did not impact SVR rates. Two patients relapsed in this study – one treatment-naïve non-cirrhotic patient with HCV genotype 1a and one treatment-experienced non-cirrhotic patient with HCV genotype 3.
Common adverse effects (AEs) (>10 percent) were headache (24 percent), fatigue (20 percent) and cough (10 percent). Three patients (4 percent) experienced serious AEs; none was related to study drug. One patient discontinued treatment after one week due to hyperglycemia. There were no deaths, graft loss or episodes of acute liver transplant rejection.
Epclusa is approved for patients with genotype 1-6 without cirrhosis or with compensated cirrhosis, and in combination with RBV for patients with decompensated cirrhosis. The safety and efficacy of Epclusa in liver transplant recipients has not been established.
Vosevi in NS5A Treatment-Experienced Patients (Poster #1178)
A deferred treatment cohort of the POLARIS-1 Phase 3 study confirmed previously reported results demonstrating the effectiveness of 12 weeks of Vosevi as salvage therapy for treatment-experienced patients. The study evaluated once-daily Vosevi in NS5A-inhibitor experienced patients with chronic HCV who were initially randomized to receive placebo in POLARIS-1.
Vosevi treatment was associated with an overall SVR12 rate of 97 percent (143/147), with 97 percent (141/145) of genotype 1 patients achieving SVR12 and 100 percent (2/2) of genotype 6 patients achieving SVR12. Four patients experienced virologic relapse after completing treatment.
The most common adverse effects (>10 percent) were fatigue (21 percent), headache (20 percent), diarrhea (19 percent) and nausea (14 percent). Six patients (4 percent) experienced serious AEs unrelated to study drug, and there were no discontinuations due to AEs.
Vosevi is approved for patients without cirrhosis or with compensated cirrhosis who have HCV genotype 1, 2, 3, 4, 5 or 6 and have been previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.
Vemlidy in Patients Switching from Viread (Poster #904) and Two Year Resistance Analysis (Oral #26)
A post-hoc analysis of a subgroup of the 1,298 treatment-naïve and treatment-experienced patients with chronic HBV infection from two Phase 3 studies (Studies 108 and 110, Poster #904) demonstrated that patients who were switched after 96 weeks of treatment with Viread to Vemlidy experienced improvements in renal function, bone mineral density (BMD) and serum alanine aminotransferase (ALT) normalization while maintaining viral suppression, after 48 weeks of treatment with Vemlidy.
In patients initially randomized to Viread, high rates of virologic control (HBV DNA <29 IU/mL) were maintained after switching from Viread to Vemlidy. When assessed at Week 96 (pre-switch), 88 percent of Viread patients (156/177) had achieved virologic suppression. When these patients were switched to Vemlidy, 89 percent (149/167) had achieved virologic suppression at Week 144.
Median creatinine clearance (CrCL) increased among switch patients by 3.6 (-3.6, +9.0) ml/min (p<0.001). Mean hip BMD (n=180) increased by 0.96 percent (2.41) (p<0.001) and spine BMD (n=181) increased by 1.83 percent (3.20) (p<0.001). In addition, rates of serum ALT normalization (by the AASLD criteria) increased from 47 percent of patients pre-switch at Week 96 to 65 percent after 48 weeks of Vemlidy (p<0.001).
A prespecified analysis that will be presented during an oral session (Oral #26) evaluated virologic resistance after 96 weeks of treatment with Vemlidy or Viread. Of the 1,242 patients who entered year two of treatment, similar percentages of patients treated with Vemlidy (10.5 percent; 87/828) or Viread (10.9 percent; 45/414) qualified for evaluation. Using genotypic and phenotypic analyses, no resistance to either Vemlidy or Viread was detected in any patients at 96 weeks.
Vemlidy is approved for the treatment of chronic HBV infection in adults with compensated liver disease. The safety and efficacy of switching virologically suppressed patients onto Vemlidy have not been established.
Important Safety Information About Harvoni, Epclusa and Vosevi
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS
Warnings and Precautions
Consult the full Prescribing Information for Harvoni, Epclusa, and Vosevi for more information on potentially significant drug interactions, including clinical comments.
Important Safety Information About Vemlidy
BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
Warnings and Precautions
Most common adverse reactions (incidence ≥5%; all grades) through Week 48 were headache, abdominal pain, fatigue, cough, nausea and back pain.
Consult the full prescribing information for Vemlidy for more information on potentially significant drug interactions, including clinical comments.
Dosage and Administration
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. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City,
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 risk
that Gilead may observe unfavorable results from additional clinical
trials involving Harvoni, Epclusa, Vosevi and Vemlidy in certain
difficult-to-treat patient populations. 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 Quarterly Report on Form 10-Q for
the quarter ended
Harvoni, Epclusa, Vosevi, Vemlidy and Viread are registered
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.
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