Research and News
HARVONI (ledipasvir 90 mg/sofosbuvir 400 mg)
Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the trade name Sovaldi® in December 2013. Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply.
In November of 2015 the U.S. Food and Drug Administration (FDA) approved Harvoni® (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014.
View Gilead Sciences Press Release
View FDA - Label Update
Feb - 2016 FDA Label Update - FDA approved changes to the Harvoni (ledipasvir and sofosbuvir) fixed-dose combination label to expand the patient population to include those with chronic hepatitis C virus genotype 1, infection who are liver transplant recipients, genotype 4 infection who are liver transplant recipients without cirrhosis, or with compensated cirrhosis, and genotype 1 infection with decompensated cirrhosis.
View FDA - Label Update
Zepatier less costly, more effective than Harvoni, Epclusa for Hepatitis C
According to recent research presented at AMCP Nexus 2016, hepatitis C genotype 1 treatment with Zepatier (elbasvir/grazoprevir; Merck) was more effective and less expensive when compared to Harvoni (ledipasvir/sofosbuvir; Gilead) and Epclusa (sofosbuvir/velpatasvir; Gilead).
Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of Patients With Hepatitis C in the Veterans Affairs National Health Care System
We investigated the real-world effectiveness of sofosbuvir, ledipasvir/sofosbuvir, and paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD) in treatment of different subgroups of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, or 4.
Florida Blue To Provide Costly Hep C Drug After Lawsuits
Florida Blue has agreed to provide coverage of the costly but life-saving hepatitis C drug Harvoni to all of its members, ending RICO and ERISA suits and bringing an equivalent of $126 million in relief to proposed class members, according to a settlement that got preliminary approval Tuesday
Comparative effectiveness of ledipasvir/sofosbuvir ± ribavirin vs. ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin HCV genotype 1 patients
Harvoni Achieves Almost 100% Response Rate in Real-World Population
In a real-world cohort of patients with genotype 1 hepatitis C virus and HIV, the hepatitis C drug Harvoni (ledpasvir/sofosbuvir; Gilead), with or without ribavirin, achieved an almost 100% sustained virologic response rate.
Shorter Course of Ledipasvir-Sofosbuvir Therapy Effective in Patients with Genotype 1 Hepatitis C
May 25, 2016 | DDW 2016 | Katherine Hasal
Results from the ION-3 trial showed that the rapidity and durability of viral suppression achieved with ledipasvir-sofosbuvir therapy allows a shorter treatment course of 8 weeks in genotype 1, treatment-naïve, non-cirrhotic patients.
ILC2016/Ledipasvir and sofosbuvir: Efficacy of all-oral treatment regimens in adolescents with Hepatitis C virus infection
The study included 100 patients aged between 12 and 18 years, infected with HCV genotype 1. In the open-label study, 100 patients received treatment with ledipasvir and sofosbuvir (90mg/400mg) once daily over a 12 week period. The primary efficacy endpoint was sustained viral response at 12 weeks post-treatment (SVR12).
Results from this study showed that of the 100 patients enrolled, 97% achieved SVR12 (n=97); the 3 patients who did not achieve SVR12 were lost to follow-up. No serious adverse events were reported, and the most common adverse events (reported by ≥10% of subjects) were headache (27%), diarrhoea (14%), fatigue (13%), nausea (12%), cough (10%) and vomiting (10%)...
Shortened Hep C Combo Passes Real-World Test
An 8-week regimen of the combination of sofosbuvir plus ledipasvir (Harvoni, Gilead Sciences) could be an option for many patients with hepatitis C, even those who don't meet the approved criteria for the shortened regime, new research shows.
Feb 21 2016
Evidence Review of Zepatier vs. Harvoni and Sovaldi for Hepatitis C
By Downloading this report you will:
Receive an in-depth review of the clinical safety and efficacy evidence for Zepatier (elbasvir, grazoprevir)
Understand how that evidence compares to Harvoni's (sofosbuvir, ledipasvir) and Sovaldi's (sofosbuvir) clinical evidence, including monograph ready tables
Gain access to the latest real world safety evidence on Harvoni and Sovaldi, including new safety signals and updated cost of side effect analysis
FDA Update -Important changes to Harvoni affecting several categories of HCV patients
On February 12, 2016, the FDA approved changes to the Harvoni (ledipasvir and sofosbuvir) fixed-dose combination label to expand the patient population to include those with chronic hepatitis C virus genotype 1, infection who are liver transplant recipients, genotype 4 infection who are liver transplant recipients without cirrhosis, or with compensated cirrhosis, and genotype 1 infection with decompensated cirrhosis.
Ledipasvir/sofosbuvir for Cirrhotic Patients With Chronic HCV
Liver International, February 11, 2016
Jan 18 2016
Sofosbuvir-based therapy for patients with chronic hepatitis C: Early experience of its efficacy and safety in Korea
In this retrospective study analyzing the efficacy of sofosbuvir based therapy for the CHC patients in Korea, a remarkable SVR 12 rate was noted, as high as 100% in both HCV genotype 1b and 2, and in both treatment-naїve and previously-treated patients.
Data on efficacy and safety were collected for CHC patients treated with a combination of sofosbuvir plus ribavirin or sofosbuvir/ledipasvir with or without ribavirin.
FDA Approves New Indications for Harvoni®, Gilead's Once-Daily Single Tablet Regimen for Chronic Hepatitis C
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Harvoni® (ledipasvir/sofosbuvir) for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin (RBV) for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014.
FDA - HARVONI (ledipasvir/sofosbuvir) label update
Ledipasvir-sofosbuvir plus ribavirin in advanced HCV does well
Key clinical point: Ledipasvir-sofosbuvir plus ribavirin for 12 weeks achieved high SVR rates among patients with hepatitis C virus infection and advanced liver disease.
Harvoni - Resident benefits from new drug that cures hepatitis C
But in recent years medications combating hepatitis C have proven more effective than ever, with Harvoni leading the way. Nancy Reau, an associate professor of medicine at the University of Chicago Medical Center who specializes in hepatitis C treatment, told the Chronicle she has prescribed the drug to many of her patients and estimated that she has seen a more than 90-percent success rate. Reau explained that its effectiveness stems from its ability to target the hepatitis C virus’ enzymes used to make more of itself, as opposed to previous drugs that focused on immune modulation.
Gilead's Harvoni® Approved By Japan's Ministry of Health
- Harvoni Achieved Cure Rates (SVR12) of 100 Percent in Japanese Phase 3 Study -
- Eliminates Need for Interferon and Ribavirin for Patients with Genotype 1 Hepatitis C -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 3, 2015-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved by the MHLW under the trade name Sovaldi® in March 2015. Harvoni is indicated for the suppression of viremia in patients with genotype 1 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis, with a treatment duration of 12 weeks.
Ledipasvir/sofosbuvir : New Hepatitis C Treatment Needs No Antiviral Boost
Harvoni induces high response rates in genotype 4, 5 HCV
Patients with genotype 4 and 5 hepatitis C virus benefitted from treatment with Harvoni, according to findings presented at the 2015 International Liver Congress.
Pharm Exec's 2015 Brand of the Year: Sovaldi and Harvoni for Hepatitis C
Gilead's Harvoni and Sovaldi Demonstrate Efficacy/Safety with Advanced Liver Disease
Harvoni Cures High Rates of Genotypes 4 and 5 of Hepatitis C
SOLAR 2: Harvoni yields high SVR12 in decompensated patients
VIENNA — Twelve or 24 weeks of Harvoni with ribavirin demonstrated 12-week sustained virologic response rates nearly 90% in decompensated patients, according to…
Harvoni with Ribavirin
Genotype 1 or 4
Slides @ NATAP
Ledipasvir/Sofosbuvir With Ribavirin is Safe and Efficacious in Decompensated and Post-Liver Transplantation Patients With HCV Infection: Preliminary Results of the SOLAR-2 Trial
Mar 24 2015
Multiple Canadian Provinces to Provide Public Funding for Gilead's Harvoni™
NEW YORK — Gilead Sciences said multiple Canadian provinces will provide access to the biotechnology company's hepatitis C drug Harvoni following a positive reimbursement recommendation from regulators...
Using Ledipasvir/Sofosbuvir in Cirrhotic, Treatment-Experienced GT1 Patients: 12 Weeks With Ribavirin or 24 Weeks Without?
Ira M. Jacobson, MD - 3/23/2015 More from this author
The recently updated AASLD/IDSA HCV management guidance recommends the following regimens for treatment-experienced patients with genotype 1 HCV infection who have compensated cirrhosis and who experienced previous treatment failure with peginterferon and ribavirin:
Ledipasvir/sofosbuvir for 24 weeks (rating: class I, level A)
Ledipasvir/sofosbuvir plus ribavirin for 12 weeks (rating: class I, level B)
Ombitasvir/paritaprevir/ritonavir plus dasabuvir and ribavirin for 12 weeks if genotype 1b HCV and for 24 weeks if genotype 1a HCV (rating: class I, level A)
Sofosbuvir plus simeprevir with or without ribavirin for 24 weeks (rating: class IIa, level B)
In this ClinicalThought commentary, I focus on considerations for the use of ledipasvir/sofosbuvir in treatment-experienced patients with genotype 1 HCV infection and cirrhosis. In an upcoming commentary, Paul Y. Kwo, MD, will have a discussion about the use of ombitasvir/paritaprevir/ritonavir and dasabuvir in this setting....
Mar 21 2015
FDA Update - Important safety information: Harvoni , and Sovaldi
Serious and Life-Threatening Cases of Symptomatic Bradycardia as well as One Case of Fatal Cardiac Arrest Reported with Coadministration of amiodarone with either Harvoni® (ledipasvir and sofosbuvir fixed-dose combination) or with Sovaldi® (sofosbuvir) in combination with another direct acting antiviral.
Mar 16 2015
Harvoni cost-effective for most patients with HCV
Harvoni is cost-effective for most patients with hepatitis C virus infection, but additional resources and value-based patient prioritization are needed, according to newly published data in Annals of Internal Medicine.
Gilead's Harvoni gains NICE yes - but won't face funding delay - genotype 1, 4 , but not genotype 3
Gilead's next generation hepatitis C pill Harvoni is set to be backed by NICE - and this time NHS England won't be delaying its funding as it has done with the firm's other hep C drug Sovaldi.
In draft guidance, NICE is recommending Harvoni (ledipasvir-sofosbuvir) as a treatment option for some adults with genotype 1 or 4 chronic hepatitis C.
Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS)
Feb 26 2015
Gilead Announces SVR12 Rates From Phase 3 Study Evaluating Harvoni® for the Treatment of Chronic Hepatitis C in Patients Co-Infected With HIV
Feb 23 2015
Mylan Signs Exclusive Agreement with Gilead Sciences to Distribute Sovaldi® and Harvoni® in India
February Issue: Gastroenterology & Endoscopy News
Shorter Hepatitis C Treatment Durations May Be a Reality
Ledipasvir-Sofosbuvir Effective In Hard-to-Treat HCV
Jan 27 2015
PBM EnvisionRx chooses Gilead hepatitis C drugs for its formulary
EnvisionRx said Gilead's Sovaldi and its newer two-drug combination pill Harvoni would be available on its formulary, with other hepatitis C drugs, such as AbbVie's Viekira Pak, allowed only as an exception in some cases.
Jan 16 2015
Aetna backs Gilead's hepatitis C treatment and gets discount
BY CAROLINE HUMER
Fri Jan 16, 2015 2:34pm EST Jan 16 (Reuters) - Aetna Inc, the third-largest U.S. health insurer, said it has negotiated a discount with Gilead Sciences Inc for its hepatitis C treatment and will offer it as the preferred choice to its nearly 20 million commercial customers.
Jan 9 2015
Anthem selects Gilead as primary supplier of hepatitis C drugs
(Reuters) - Health insurer Anthem Inc on Thursday said it reached a deal under which Gilead Sciences Inc's hepatitis C drug Harvoni will be the primary treatment for patients infected with the most common strain of the liver-destroying virus.
At $594 Per Dose Gilead Sciences, Inc. (GILD) Hepatitis Drug Is Too Costly For Veterans Affairs Department
To consider the impact of Sovaldi’s $84,000 12-week treatment cost, the Veterans Affairs Department provides this therapy only to the sickest patients who need it. The Department is the largest single provider of hepatitis C care in the U.S., which enabled it to negotiate more than 40% discount to the $594 per-dose price with Gilead.
UPDATE: Gilead (GILD), AbbVie (ABBV) Hep. C Drugs Both Given Prefered Status at Prime
A press release is below.
People with Hepatitis C who are served by pharmacy benefit manager Prime Therapeutics LLC (Prime) will now have greater support for the treatment recommended by their physician. This is a result of new agreements between Prime and pharmaceutical companies Gilead Sciences and AbbVie. Beginning immediately, the agreements place both Gilead's Harvoni® and AbbVie's Viekira Pak® on Prime's preferred drug list (formulary), meaning members can more easily get the medicine they need to feel better and live well.
Jan 5 2015
Gilead exclusive provider of hepatitis C medicine for CVS
Gilead Sciences Inc. was chosen over AbbVie Inc. as the main provider of hepatitis C medicine for patients covered through CVS Health Corp., intensifying a rivalry to treat patients with pills that cost $1,000 or more a day.
Patient Advocate Foundation Offers New CareLine for Hepatitis C Patients
Hepatitis C CareLine, providing individualized, sustained assistance to patients diagnosed with Hepatitis C. The CareLine will provide help to patients across the country to resolve healthcare access and insurance issues, at no charge to the patient.
Drug pricing concerns? Not at Gilead
After drug pricing concerns weighed on Gilead Sciences' stock toward the end of December, the drugmaker has kicked off 2015 the same way it did the previous two years: by increasing prices on several products.
Jan 4 2015
Is there a balm for Gilead?
Doctors and Patients prefer Gilead’s Harvoni because only one pill a day is required. Patients on Viekira Pak must take four pills (or more) — three in the morning and one in the afternoon. Furthermore, patients on Viekira Pak frequently must take ribavirin, which can cause serious side effects. Harvoni causes only “minor” side effects such as nausea, headache and diarrhea. Accordingly, Harvoni was the “drug of choice” in the marketplace until recently.