Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Ledipasvir and sofosbuvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2 and 2.3) and Clinical Studies (14) ]: genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin genotype 1 or 4… FDA label
Also known as Harvoni
ledipasvir/sofosbuvir · 5 trials · 7 indications
Resolution of active PCT, defined as normalization of plasma porphyrins (less than 0.9 mcg/dL) by 7 months after start of therapy
Number of participants who attain SVR, ie, cleared HCV
Response to medication in patients with MC categorized as either complete response (100% response) vs partial response (50% response).
Subjects with chronic hepatitis B will be give 12 weeks of ledipasvir and/or sofosbuvir and their HBsAg will be measured at baseline, on each visits during therapy, and at end of therapy (week 12). The change (decline) in HBsAg from baseline to end of the 12 week treatment will be compared.
Number of subjects who discontinued study drug due to adverse event
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
| Arm | Type | Description |
|---|---|---|
| Ledipasvir/Sofosbuvir | OTHER | Each tablet contains 90 mg ledipasvir and 400 mg sofosbuvir, given orally, once daily for 24 weeks. |
| Harvoni | EXPERIMENTAL | 1 tablet per day, oral, taken with or without food. 8 weeks for patients without cirrhosis, not previously treated with HCV GT1 and HCV rNA \< 6 million IU/mL; 12 weeks for patients without cirrhosis; 24 weeks for patients with compensated cirrhosis |
| Participant with Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia | EXPERIMENTAL | Participants treated with either Harvoni or Epclusa * Harvoni 90mg/400 mg FDC once daily. Subjects will take 1 tablet daily with or without food. * Epclusa 400mg/100mg 400mg/100mg FDC once daily |
| Group A (LDV/SOF for low replicative HBV) | EXPERIMENTAL | 12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B in low replicative state. |
| Group B (LDV/SOF for viral suppressed HBV) | EXPERIMENTAL | 12 week treatment with ledipasvir/sofosbuvir (Harvoni) for chronic hepatitis B, virally suppressed. |
| Group C (SOF for low replicative HBV) | EXPERIMENTAL | 12 weeks treatment with sofosbuvir (Sovaldi) for chronic hepatitis B in low replicative state. Randomized 1:1 with Group D. |
| Group D (LDV for low replicative HBV) | EXPERIMENTAL | 12 weeks treatment with ledipasvir for chronic hepatitis B in low replicative state. Randomized 1:1 with Group C. |
| Name | Type | Description |
|---|---|---|
| Ledipasvir/Sofosbuvir | DRUG | Each tablet of Harvoni contains 90 mg ledipasvir and 400 mg sofosbuvir. |
| Harvoni | DRUG | One capsule of Harvoni/ ledipasvir, 90 mg + sofosbuvir, 400 mg administered daily for 8, 12, or 24 weeks |
| Epclusa | DRUG | once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects. |
| Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni] | DRUG | 1 pill once daily for 12 weeks for Group A |
| Sofosbuvir 400 MG [Sovaldi] | DRUG | 1 pill once daily for 12 weeks for Group C |
| Ledipasvir 90 MG | DRUG | 1 pill once daily for 12 weeks for Group D |
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 ...
Ledipasvir/sofosbuvir is a small molecule antiviral combination studied for hepatitis C, including chronic hepatitis C, and for hepatitis B. It has been evaluated in chronic hepatitis C genotype 1 infection with decompensated cirrhosis and in hepatitis C during pregnancy, as well as in hepatitis B virus infection.
Ledipasvir/sofosbuvir is developed by Gilead Sciences, Inc., which trades under the ticker GILD. Gilead is the sponsor behind the clinical studies of the combination in hepatitis B and hepatitis C, including the Phase 2 hepatitis B trial and the Phase 3 decompensated cirrhosis trial.
Ledipasvir/sofosbuvir has been studied across Phase 1, Phase 2, and Phase 3 clinical trials, and all of those trials are now completed. The Phase 2 study evaluated the combination in hepatitis B virus infection, while a Phase 3 study evaluated it in chronic hepatitis C genotype 1 with decompensated cirrhosis.
Ledipasvir/sofosbuvir has been tested in completed trials including NCT03312023, a Phase 2 study in hepatitis B virus infection with 21 participants in the United States, NCT02683005, a Phase 1 study of hepatitis C treatment during pregnancy, and NCT02597166, a Phase 3 study in chronic hepatitis C genotype 1 with decompensated cirrhosis in Canada.
Yes. Ledipasvir/sofosbuvir is also known as ledipasvir 90 MG / sofosbuvir 400 MG oral tablet, which is the fixed-dose combination marketed under the name Harvoni. The alternative written form ledipasvir/ sofosbuvir refers to the same combination product.
The ledipasvir/sofosbuvir trials listed enrolled small numbers of participants. The Phase 2 hepatitis B study enrolled 21 patients, the Phase 1 pregnancy study enrolled 9 patients, and the Phase 3 decompensated cirrhosis study enrolled 14 patients, for a total of 44 participants across the three completed studies.