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Ledipasvir/Sofosbuvir

Phase 3

Hepatitis C, Chronic | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Mar 4, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Ledipasvir/Sofosbuvir · 2 trials · 4 indications

Phase 3 1Phase 1 1
NCT02597166Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 InfectionHepatitis C, Chronic
COMPLETED14 Analytics
PHASE3COMPLETED
Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection
Hepatitis C, Chronic
NCT0259716614
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Study Endpoints

Primary Endpoints

Improvement of quality of life based on Chronic Liver Disease Questionnaire
one year
Area Under Curve (AUC) Time Frame: predose, 0.5 hr, 1 hr, 2, 3, 4, 5, 8, 12 hrs
3 gestational age time points during the 12 weeks of treatment: 1) Between 25 + 0 and 26 + 5; 2) Between 29 + 0 and 30 + 6; 3) 33 + 0 and 34 + 6 weeks' gestation

Systemic exposure both LDV and SOF (SOF and inactive metabolite GS-331007) will be assessed at 3 gestational age time points: 1) Late second trimester between 25 + 0 and 26 + 5 weeks' gestation (after at least 10 days of therapy); 2) Early third trimester between 29 + 0 and 30 + 6 weeks' gestation; 3) Late third trimester between 33 + 0 and 34 + 6 weeks' gestation

Secondary Endpoints

Sustained viral response at 12 weeks post treatment (SVR 12)
-HCV RNA viral load will be assessed at 12 weeks after completion of LDV/SOF treatment
Number of Maternal Adverse Events
-From enrollment to 12 weeks after treatment completion
Number of Participants With Abnormal Laboratory Values
-From enrollment to 12 weeks after treatment completion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ledipasvir/SofosbuvirOTHEREach tablet contains 90 mg ledipasvir and 400 mg sofosbuvir, given orally, once daily for 24 weeks.

Interventions

NameTypeDescription
Ledipasvir/SofosbuvirDRUGEach tablet of Harvoni contains 90 mg ledipasvir and 400 mg sofosbuvir.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Treatment-naïve and treatment-experienced patients with CHC genotype 1 infection and decompensated cirrhosis as defined by one of the following: * history of variceal bleeding * presence or history of ascites * history of grade III-IV hepatic encephalopathy * Coagulopathy with ...

Countries:CanadaUnited States
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Frequently asked questions about Ledipasvir/Sofosbuvir

What is Ledipasvir/Sofosbuvir used for?

Ledipasvir/Sofosbuvir is used for the treatment of chronic Hepatitis C infection. It is being studied in patients with decompensated cirrhosis due to Hepatitis C genotype 1 infection and in pregnant women with Hepatitis C. The drug is a small molecule developed by Gilead Sciences, Inc. (GILD).

What does Ledipasvir/Sofosbuvir target?

Ledipasvir/Sofosbuvir targets the Hepatitis C virus. Ledipasvir inhibits the NS5A protein, and sofosbuvir inhibits the NS5B RNA polymerase, both essential for viral replication. This combination directly acts on the virus to reduce its ability to multiply in the body.

Who makes Ledipasvir/Sofosbuvir?

Ledipasvir/Sofosbuvir is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead is responsible for the clinical development and commercialization of the drug.

What phase is Ledipasvir/Sofosbuvir in?

Ledipasvir/Sofosbuvir is in Phase 3 clinical development for chronic Hepatitis C. It is an investigational drug and has not been approved by the FDA. A Phase 3 trial has been completed, and a Phase 1 trial has also been completed.

What clinical trials is Ledipasvir/Sofosbuvir in?

Ledipasvir/Sofosbuvir has completed a Phase 3 trial (NCT02597166) in patients with decompensated cirrhosis due to Hepatitis C genotype 1 infection, enrolling 14 participants in Canada. It also completed a Phase 1 trial (NCT02683005) studying Hepatitis C treatment during pregnancy, enrolling 9 women in the United States.

Is Ledipasvir/Sofosbuvir the same as Harvoni?

Yes, Ledipasvir/Sofosbuvir is the same as Harvoni. The Phase 3 trial NCT02597166 is titled 'Effects of Harvoni in Patients With Decompensated Cirrhosis Due to Hepatitis C Genotype 1 Infection,' confirming that Harvoni is the brand name for this combination drug.