Drugs / Sofosbuvir
Sofosbuvir
also known as
SOF · Sovaldi · PSI-7977 · GS-7977 · Sovaldi is a trade name of sofosbuvir · Heterosofir · Psi-7977, gs-7977 · Sofosbuvir (GS-7977) · +5 more
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis C virus infection 3 milestones | |||||
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2018-03-01 | “announced that it has filed an Abbreviated New Drug Application (ANDA) for Sofosbuvir Tablets, 400mg, with the U.S. Federal Drug Administration (USFDA).” natcopharma.co.in ↗ |
| Filed | Japan (PMDA) | — | chronic hepatitis C virus infection | 2014-09-24 | “today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of an investigational...” gilead.com ↗ “NDA to Japan's Pharmaceutical and Medical Devices Agency for approval of a once-daily fixed-dose combination of ledipasvir (LDV) 90 mg and sofosbuvir (SOF) 400 mg” gilead.com ↗ “Gilead filed a New Drug Application (NDA) in Japan for a single-tablet regimen of sofosbuvir and the NS5A inhibitor ledipasvir” gilead.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2013-04-08 | “a supplemental New Drug Application (sNDA) was submitted to the FDA seeking approval for simeprevir in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir” jnj.com ↗ “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for approval of sofosbuvir” gilead.com ↗ |
| Filed hepatitis C virus infection 1 milestone | |||||
| Filed | US (FDA) | — | hepatitis C virus infection | 2014-08-21 | “A supplemental New Drug Application for simeprevir in combination with sofosbuvir was submitted to the US FDA.” medivir.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (2) | US (FDA) | SOVALDI | — | 2017-04-07 – 2019-08-28 | fda.gov ↗ |
| Filed | Japan (PMDA) | — | hepatitis C, genotype 2 | 2014-06-27 | “today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of sofosbuvir” gilead.com ↗ |
| Approved | EU (EMA) | Sovaldi | — | 2014-01-16 | europa.eu ↗ |
| Approved | US (FDA) | SOVALDI | — | 2013-12-06 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 88
| Date | Issuer | Release |
|---|---|---|
| 2026-07-28 | Atea Pharmaceuticals, Inc. | Results Atea Pharmaceuticals Meets Both Its Primary and Secondary Endpoints in the Phase 3 C-BEYOND North America Trial Evaluating Bemnifosbuvir/Ruzasvir for Hepatitis C Virus ateapharma.com ↗
BEM/RZR demonstrated statistical non-inferiority compared to the fixed-dose combination of sofosbuvir and velpatasvir (SOF/VEL) in the modified intent-to-treat (mITT) population, achieving the trial’s primary endpoint. |
| 2026-04-27 | Drugs for Neglected Diseases | Regulatory Thailand registers ravidasvir, a simple-to-use and effective antiviral for hepatitis C, expanding treatment options for Thai patients dndi.org ↗
Ravidasvir is approved for use in combination with another antiviral called sofosbuvir. |
| 2022-11-01 | Gilead Sciences | Results Gilead to Present Data Across Viral Hepatitis and Liver Fibrosis at The Liver Meeting® 2022, Reinforcing Gilead as a Leader in Addressing Treatment Needs for People Living With Liver Disease gilead.com ↗
GS-2829 / GS-6779 HBV Therapeutic Vaccine Generates Robust, Polyfunctional, Genotype Cross-Reactive CD8 T Cell Responses Accompanied by High Titers of Anti-HBsAg Antibodies |
| 2021-06-14 | Drugs for Neglected Diseases | Regulatory First hepatitis C treatment developed through South-South cooperation registered in Malaysia dndi.org ↗
The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has granted a conditional registration for a safe, effective hepatitis C treatment developed by a public-private partnership bringing together the Malaysian Ministry of Health, not-for-profit research and development organization Drugs for Neglected Diseases initiative (DNDi), Egyptian pharmaceutical company Pharco, Malaysian pharmaceutical company Pharmaniaga Berhad, and non-governmental-organization Médecins Sans Frontières/Doctors Without Borders (MSF). |
| 2021-06-10 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves New Formulation of Epclusa®, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C gilead.com ↗
The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200 mg/velpatasvir 50 mg and sofosbuvir 150 mg/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. |
| 2020-03-19 | Gilead Sciences | Regulatory U.S. Food And Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection gilead.com ↗
Epclusa is the first pan-genotypic, protease inhibitor-free regimen approved in the United States for adults and children. |
| 2019-12-20 | Gilead Sciences | Regulatory China National Medical Products Administration Approves Vosevi® (Sofosbuvir, Velpatasvir and Voxilaprevir) for People With Chronic Hepatitis C Infection Who Require Re-Treatment gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China National Medical Products Administration (NMPA) has approved Vosevi ® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy. |
| 2019-04-11 | Gilead Sciences | Results Gilead Presents New Data on Viral Hepatitis at the International Liver Congress™ 2019 gilead.com ↗ |
| 2019-03-30 | Pharco Pharmaceuticals | Regulatory PHARCO Pharmaceuticals, Inc. receives World Health Organization Prequalification for HCV Medicine Sofosbuvir Tablets pharco.org ↗
PHARCO Pharmaceuticals, Inc. has announced that on the 18th of December 2018 the World Health Organization (WHO) granted prequalification for SOFOSBUVIR 400 mg Tablets, manufactured at its European Egyptian Pharmaceutical Industries (EEPI). |
| 2018-12-04 | Gilead Sciences | Regulatory China’s National Medical Products Administration Approves Harvoni® (Ledipasvir/Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Genotype 1-6 gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the National Medical Products Administration (NMPA) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) in China for the treatment of chronic hepatitis C virus (HCV) genotype 1-6 infection in adults and adolescents aged 12 to 18 years. |
| 2018-05-30 | Gilead Sciences | Regulatory China Drug Administration Approves Epclusa® (Sofosbuvir/Velpatasvir), Gilead’s Pan-Genotypic Treatment for Chronic Hepatitis C Virus Infection gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Drug Administration (CDA) has approved Epclusa ® (sofosbuvir 400 mg/velpatasvir 100 mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. |
| 2018-05-15 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Expanded Indication for Truvada® (Emtricitabine and Tenofovir Disoproxil Fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents gilead.com ↗
Truvada for PrEP is now indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. |
| 2018-04-11 | Drugs for Neglected Diseases | Results New affordable hepatitis C combination treatment shows 97% cure rate | DNDi dndi.org ↗ |
| 2018-03-01 | NATCO Pharma Ltd. | Regulatory NATCO announces USFDA filing for Sofosbuvir tablets, 400 mg natcopharma.co.in ↗
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced that it has filed an Abbreviated New Drug Application (ANDA) for Sofosbuvir Tablets, 400mg, with the U.S. Federal Drug Administration (USFDA). |
| 2017-10-20 | Gilead Sciences | Results 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® gilead.com ↗ |
| 2017-09-19 | Drugs for Neglected Diseases | Regulatory DNDi welcomes Malaysia’s move to secure access to more affordable treatments for hepatitis C | DNDi dndi.org ↗
Malaysia has issued a “government use” licence enabling access to more affordable versions of an expensive and patented medicine to treat hepatitis C. |
| 2017-08-01 | Gilead Sciences | Regulatory U.S. FDA Approves Expanded Labeling for Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV gilead.com ↗ |
| 2017-07-18 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Vosevi™ (Sofosbuvir/Velpatasvir/Voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus gilead.com ↗ |
| 2017-04-22 | Merck Sharp & Dohme LLC | Results Merck Announces New Phase 2 Data on Investigational Triple Combination Therapy MK-3682B for Chronic Hepatitis C merck.com ↗
The study showed that 100 percent (43/43) of patients who completed 16 weeks of treatment plus ribavirin (RBV) achieved SVR12 and 100 percent (49/49) of patients who completed 24 weeks of treatment achieved SVR12 (abstract PS-159). |
| 2017-04-21 | Gilead Sciences | Results Gilead Announces Scientific Presentations Demonstrating Efficacy of Harvoni® (Ledipasvir/Sofosbuvir) in Special Patient Populations With HCV Infection gilead.com ↗
The studies demonstrated HCV cure rates of 99 percent in children aged 6 to 11 years (#PS-101), and 100 percent in adult patients co-infected with HCV and hepatitis B virus (HBV) (#PS-098). |
| 2017-04-21 | AbbVie | Results Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR(12) Rates in Challenging to Treat Genotype 3 Chronic Hepatitis C abbvie.com ↗
In results from the Phase 3 ENDURANCE-3 study, 95 percent (n=149/157) of GT3 chronic HCV infected patients without cirrhosis and who are new to treatment achieved sustained virologic response at 12 weeks post-treatment (SVR 12 ) following 8 weeks of treatment with G/P. |
| 2017-04-20 | AbbVie | Results AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved 99 Percent SVR(12) Rate in Chronic Hepatitis C Patients with Compensated Cirrhosis abbvie.com ↗
SVR 12 was achieved by 145/146 (99 percent) patients, with one GT1a-infected patient experiencing relapse. |
| 2017-04-07 | Gilead Sciences | Regulatory U.S. FDA Approves New Indications for Harvoni® and Sovaldi® in Pediatric Patients 12 Years and Older with Chronic Hepatitis C Infection gilead.com ↗
Sovaldi was approved for pediatric patients with genotype 2 or 3 chronic HCV infection, in combination with ribavirin. |
| 2017-04-05 | Merck Sharp & Dohme LLC | Results Merck to Present New Data on ZEPATIER® (elbasvir and grazoprevir) and Investigational Combination Therapy MK-3682B for the Treatment of Chronic Hepatitis C Infection at The International Liver Congress™ 2017 merck.com ↗
Successful Treatment of Patients With HCV GT3 Infection and Cirrhosis with Elbasvir/Grazoprevir Plus Sofosbuvir Does Not Correct Insulin Resistance by 12 weeks Post-Treatment |
| 2016-11-15 | AbbVie | Results AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Shows High SVR Rates in Chronic Hepatitis C Patients with Severe Chronic Kidney Disease abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR 12 ) with its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. |
| 2016-11-13 | Merck Sharp & Dohme LLC | Results Merck Announces Findings for Investigational Triple-Combination Chronic Hepatitis C Therapy Showing High Rates of Sustained Virologic Response in People with Genotypes 1, 2 or 3 Infection merck.com ↗
Findings from C-CREST 1 & 2 Part B also demonstrated high rates of SVR12 in GT1, GT2 and GT3-infected patients who received MK3 for 12 or 16 weeks. |
| 2016-11-11 | AbbVie | Results Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates Across All Major Genotypes of Chronic Hepatitis C abbvie.com ↗
In more than 700 genotype 1-6 (GT1-6) chronic HCV infected patients without cirrhosis and who are new to treatment, 97.5 percent (n=693/711) achieved sustained virologic response at 12 weeks post treatment (SVR 12 ), regardless of baseline viral load. |
| 2016-06-28 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C gilead.com ↗
Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). |
| 2016-04-13 | Merck Sharp & Dohme LLC | Results Merck’s ZEPATIER™ (Elbasvir and Grazoprevir) Showed Superiority on Efficacy and Safety Endpoints Compared to Sofosbuvir Plus Peginterferon and Ribavirin Treatment Regimen in Phase 3 Trial merck.com ↗
In this study, ZEPATIER demonstrated superiority on efficacy and safety endpoints compared to sofosbuvir plus pegIFN/RBV, based on pre-specified analyses. |
| 2016-02-16 | Gilead Sciences | Regulatory U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved additional indications for Harvoni ® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. |
| 2015-11-16 | Janssen Research & Development, LLC | Results Janssen Presents New Data Assessing OLYSIO® (Simeprevir) in Combination with Sofosbuvir in Genotype 4 Infected HCV Patients In Egypt jnj.com ↗ |
| 2015-11-16 | Bristol-Myers Squibb | Results Data from ALLY-3+ Trial Investigating Daklinza (daclatasvir) in Combination with Sofosbuvir and Ribavirin in Chronic Hepatitis C Genotype 3 Patients with Advanced Fibrosis or Cirrhosis Presented at AASLD bms.com ↗
Daclatasvir+sofosbuvir+ribavirin regimen for 12 or 16 weeks achieved SVR12 rates of 88% and 92%, respectively, in genotype 3 patients with advanced fibrosis or cirrhosis |
| 2015-11-12 | Gilead Sciences | Regulatory U.S. FDA Approves New Indications for Harvoni®, Gilead’s Once-Daily Single Tablet Regimen for Chronic Hepatitis C gilead.com ↗ |
| 2015-07-23 | Janssen Research & Development, LLC | Regulatory Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral, Once-Daily OLYSIO® (Simeprevir) in Combination with Sofosbuvir jnj.com ↗
Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral, Once-Daily OLYSIO® (Simeprevir) in Combination with Sofosbuvir |
| 2015-07-03 | Gilead Sciences | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗
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. |
| 2015-05-20 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives Amended U.S. FDA Breakthrough Therapy Designation for Investigational Daclatasvir-based Hepatitis C Regimen bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy Designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients. |
| 2015-04-25 | Merck Sharp & Dohme LLC | Results Merck Announces Presentation of Phase 2 Clinical Trial Results of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir at the International Liver CongressTM 2015 merck.com ↗
Results of C-SWIFT Study Provide Proof-of-Concept for Shorter Than Twelve Weeks Duration of Treatment with Triple-DAA Regimen in Patients with Chronic Hepatitis C Virus (HCV) Genotypes 1 and 3 Infection |
| 2015-04-25 | Gilead Sciences | Results Gilead Announces Results From Studies Evaluating Sofosbuvir-Based Regimens in Chronic Hepatitis C Patients With Genotypes 2-5 gilead.com ↗
Results from the BOSON study of Sovaldi ® (sofosbuvir 400 mg) in combination with ribavirin (RBV) or with pegylated interferon (PEG)/RBV demonstrated high cure rates across all patients with genotypes 2 and 3. |
| 2015-04-25 | Bristol-Myers Squibb | Results ALLY-1 Trial Results Show Investigational Daclatasvir-Based Regimen Cures 94% of Post-Liver Transplant Patients with Hepatitis C and Up to 94% of Hepatitis C Patients with Cirrhosis (Child-Pugh Class A or B) bms.com ↗
The study’s primary endpoints were reached, with 95% of post-transplant genotype 1 patients and 82% of genotype 1 patients with advanced cirrhosis achieving SVR12. |
| 2015-04-23 | Janssen Research & Development, LLC | Results Janssen Announces SVR12 Rates with Twelve Weeks of Treatment with All-Oral, Once-Daily Regimen of Simeprevir ▼ Plus Sofosbuvir ▼ in Genotype 1 HCV Patients With and Without Cirrhosis jnj.com ↗ |
| 2015-04-23 | Gilead Sciences | Results Gilead’s Harvoni and Sovaldi Demonstrate Efficacy and Safety among Chronic Hepatitis C Patients with Advanced Liver Disease gilead.com ↗ |
| 2015-04-23 | Gilead Sciences | Results Gilead Announces Data for Investigational, All-Oral, Pan-Genotypic Three-Drug Regimen of Sofosbuvir, GS-5816 and GS-9857 for Chronic Hepatitis C gilead.com ↗
demonstrated sustained virologic response (SVR12) rates following six weeks of treatment of 93 percent (n=14/15) among treatment-naïve, non-cirrhotic patients |
| 2015-04-13 | Ascletis Pharmaceuticals Co., Ltd. | Results HCV RACE IN CHINA ascletis.com ↗
The data showed a sustained virologic response in more than 97% of patients. |
| 2015-04-08 | AbbVie | Results AbbVie to Present New Data from Hepatitis C Clinical Development Program at The International Liver Congress™ 2015 abbvie.com ↗
No Significant Interaction Among Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir and Sofosbuvir |
| 2015-03-26 | Gilead Sciences | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Sovaldi® (sofosbuvir) for the Treatment of Genotype 2 Chronic Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Sovaldi ® (sofosbuvir), a once-daily nucleotide analog polymerase inhibitor, for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis. |
| 2015-02-26 | Gilead Sciences | Results Gilead Announces SVR12 Rates From Phase 3 Study Evaluating Harvoni® for the Treatment of Chronic Hepatitis C in Patients Co-Infected With HIV gilead.com ↗
In the trial, 96 percent (n=321/335) of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). |
| 2015-02-26 | Bristol-Myers Squibb | Results ALLY Trial Demonstrates 97% Hepatitis C Cure Rates Among Patients Coinfected with HIV After Ribavirin-Free Investigational 12-Week Regimen of Daclatasvir and Sofosbuvir bms.com ↗
Among ALLY-2 patients treated for 12 weeks (treatment-naïve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment; SVR12). |
| 2014-11-11 | Gilead Sciences | Results Gilead Announces Phase 2 Data for Investigational All-Oral Regimen of Sofosbuvir Plus GS-5816 for the Treatment of Chronic Hepatitis C gilead.com ↗
Rates of sustained virologic response (SVR12) ranged from 88 percent to 100 percent among those receiving SOF plus GS-5816 100 mg for 12 weeks – the regimen selected for Phase 3 studies. |
| 2014-11-11 | Gilead Sciences | Results Gilead Announces Harvoni Study Results in Chronic Hepatitis C Patients with Advanced Liver Disease and Those Who Failed Prior Treatment gilead.com ↗
Ninety-six percent (n=74/77) of those receiving Harvoni plus RBV for 12 weeks and 97 percent (n=75/77) of those receiving Harvoni for 24 weeks achieved SVR12. |
| 2014-11-09 | Merck Sharp & Dohme LLC | Results Interim Data from Proof-of-Concept Study of Merck’s Investigational Hepatitis C Treatment Grazoprevir/Elbasvir in Combination with a Nucleotide Inhibitor (C-SWIFT study) Presented at The Liver Meeting® merck.com ↗
“These interim data provide a compelling proof-of-concept for the potential of an eight- or six-week triple therapy course in treatment-naive patients with genotype 1 disease, including cirrhotic patients,” said Dr. Lawitz. |
| 2014-11-08 | Bristol-Myers Squibb | Results ALLY Trial Demonstrates High Cure Rates for Investigational Daclatasvir and Sofosbuvir Combination among Genotype 3 Hepatitis C Patients bms.com ↗
The ALLY-3 results demonstrate the possibility of bringing a cure to genotype 3 patients in an all-oral, 12-week regimen. |
| 2014-11-05 | Janssen Research & Development, LLC | Regulatory OLYSIO® (simeprevir) Gains Additional FDA Approval as Once-Daily, All-Oral Interferon- and Ribavirin-Free Treatment Option in Combination with Sofosbuvir for Adults with Genotype 1 Chronic Hepatitis C Infection jnj.com ↗
Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved OLYSIO® (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. |
| 2014-09-26 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults gilead.com ↗
The CHMP opinion was adopted following an accelerated review procedure, which is reserved for medicinal products that are expected to be of major public health interest. |
| 2014-07-28 | Janssen Research & Development, LLC | Results Phase 2 COSMOS Study Results Published in The Lancet Demonstrate Efficacy and Safety of Janssen's Once-Daily Simeprevir in All Oral 12-Week Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C jnj.com ↗
Phase 2 COSMOS Study Results Published in The Lancet Demonstrate Efficacy and Safety of Janssen's Once-Daily Simeprevir in All Oral 12-Week Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C |
| 2014-06-15 | Gilead Sciences | Results Gilead Announces Phase 3 Data Showing That the Fixed-Dose Combination of Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained Virologic Response (SVR12) Among Patients with Chronic Hepatitis C in Japan gilead.com ↗
Among patients receiving 12 weeks of LDV/SOF without RBV, 100 percent (n=83/83) of treatment-naïve and 100 percent (n=88/88) of treatment-experienced patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). |
| 2014-05-07 | Janssen Research & Development, LLC | Regulatory Study Found INVEGA® SUSTENNA® (paliperidone palmitate) Once-Monthly Long-Acting Therapy Delayed Time to and Reduced Risk of Relapse in Individuals with Schizoaffective Disorder as Monotherapy and Adjunctive Therapy jnj.com ↗
Janssen Submits Supplemental New Drug Application to U.S. FDA for OLYSIO™ (Simeprevir) for Once -Daily Use in Combination with Sofosbuvir |
| 2014-04-12 | Janssen Research & Development, LLC | Results Final Data from the Phase 2 COSMOS Study of Janssen's Once-Daily Simeprevir in Combination with Sofosbuvir Presented at The International Liver Congress™ 2014 of the European Association for the Study of the Liver (EASL) jnj.com ↗
Final results from cohort 2 of the Phase 2 COSMOS study demonstrated that 93 percent of patients with genotype 1 HCV and advanced liver fibrosis (METAVIR scores F3 and F4) who were treated with simeprevir and sofosbuvir for 12 weeks achieved sustained virologic response 12 weeks after the end of treatment (SVR12). |
| 2014-04-11 | Gilead Sciences | Results Gilead’s Sovaldi® Demonstrates Efficacy and Safety Among Chronic Hepatitis C Patients with Advanced Liver Disease gilead.com ↗
Of the 22 patients who completed 24 weeks of therapy, 95 percent (n=21/22) achieved virologic suppression on treatment. |
| 2014-04-10 | Gilead Sciences | Results Gilead Announces Results from Study of Sovaldi® for Retreatment of Chronic Hepatitis C in Patients Not Cured with Prior Antiviral Therapy gilead.com ↗
Among the 50 patients for whom sustained virologic response data was available 12 weeks after the end of treatment (SVR12), 74 percent (n=37/50) achieved SVR12. |
| 2014-04-10 | Gilead Sciences | Results Gilead Announces Phase 2 Results for Two Investigational All-Oral Sofosbuvir-Based Regimens for the Treatment of Chronic Hepatitis C gilead.com ↗
Among genotype 1-infected patients who had failed prior treatment with SOF plus RBV, 100 percent (19/19) achieved SVR12 following 12 weeks of LDV/SOF plus RBV. |
| 2014-01-17 | Gilead Sciences | Regulatory European Commission Grants Marketing Authorization for Gilead’s Sovaldi® (Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection gilead.com ↗ |
| 2013-12-16 | Gilead Sciences | Regulatory Health Canada Issues Notice of Compliance for Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Health Canada has issued a Notice of Compliance for Sovaldi™ (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection. |
| 2013-12-06 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved Sovaldi™ (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. |
| 2013-11-22 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Gilead Sciences’ Sovaldi® for the Treatment of Chronic Hepatitis C Infection gilead.com ↗
The CHMP opinion supports the approval of Sovaldi for the treatment of HCV in combination with other agents. |
| 2013-11-04 | Medivir | Results Results from the COSMOS study with Simeprevir and Sofosbuvir in cirrhotic and non-cirrhotic HCV genotype 1 patients presented at AASLD medivir.com ↗
The high sustained virologic response (SVR) rates seen in genotype 1 patients with prior null response and in treatment-naïve and prior null response patients with advanced liver disease, in the COSMOS study, are highly encouraging. |
| 2013-11-02 | Gilead Sciences | Results Gilead Announces Phase 3 Results for an All-Oral, Sofosbuvir-Based Regimen for the Treatment of Hepatitis C in Patients Co-Infected With HIV gilead.com ↗
In the trial, 76 percent (n=87/114) of genotype 1 HCV treatment-naïve patients receiving 24 weeks of an all-oral, interferon-free regimen of sofosbuvir plus ribavirin (RBV) achieved a sustained virologic response 12 weeks after completing therapy (SVR12). |
| 2013-11-02 | Gilead Sciences | Results Gilead Announces Phase 2 Results for Sofosbuvir-Based Regimens in Hepatitis C Patients Before and After Liver Transplantation gilead.com ↗ |
| 2013-11-02 | Gilead Sciences | Results Gilead Announces New Sustained Viral Response Data for Sofosbuvir-Based Regimens in Genotype 3-Infected Hepatitis C Patients gilead.com ↗
In the Phase 3 VALENCE study, 85 percent (n=212/250) of treatment-naïve or treatment-experienced patients with genotype 3 HCV who received a 24-week regimen of sofosbuvir plus ribavirin (RBV) achieved a sustained virologic response 12 weeks after treatment (SVR12). |
| 2013-10-25 | Gilead Sciences | Regulatory FDA Advisory Committee Supports Approval of Gilead’s Sofosbuvir for Chronic Hepatitis C Infection gilead.com ↗
Committee members also voted unanimously (15-0) that the available data support approval of sofosbuvir in combination with pegylated interferon and ribavirin for the treatment of chronic hepatitis C in treatment-naïve adult patients with genotype 1 and 4 infection. |
| 2013-08-28 | Medivir | Results Medivir announces interim results from Cohort 2 of the COSMOS study evaluating Simeprevir and Sofosbuvir in HCV patients with METAVIR scores F3-F4 medivir.com ↗
Treatment for 12 weeks with simeprevir and sofosbuvir, with or without ribavirin, led to SVR4 rates of 96% and 100%, respectively. |
| 2013-06-07 | Gilead Sciences | Regulatory Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has granted priority review to the company’s New Drug Application (NDA) for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. |
| 2013-05-21 | Gilead Sciences | Regulatory European Medicines Agency Validates Gilead’s Marketing Application for Sofosbuvir for the Treatment of Hepatitis C gilead.com ↗ |
| 2013-05-02 | Gilead Sciences | Results Gilead Reports Interim Data From Phase 2 LONESTAR Study gilead.com ↗ |
| 2013-04-23 | Gilead Sciences | Results Data from Phase 3 Studies of Gilead’s Sofosbuvir for Hepatitis C To Be Presented at 48th Annual EASL Meeting; Findings Published Online Today in The New England Journal of Medicine gilead.com ↗
Overall SVR12 rates (sustained viral response 12 weeks after completing therapy) from 50 to 90 percent were observed. |
| 2013-04-08 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C gilead.com ↗ |
| 2013-03-26 | Gilead Sciences | Results Gilead Announces Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients gilead.com ↗
This recommendation is based upon the observed SVR4 rates exceeding the predefined threshold of 60 percent and the absence of significant safety issues. |
| 2013-03-06 | Medivir | Results Results from a phase IIa study evaluating Simeprevir and Sofosbuvir in prior null responder Hepatitis C patients have been presented at CROI medivir.com ↗
In an all-oral regimen of simeprevir and sofosbuvir 96.3 percent (26/27) and 92.9 percent (13/14) of patients in the 12-week arm with ribavirin and without ribavirin achieved sustained virologic response 8 weeks after the end of treatment (SVR8). |
| 2013-03-04 | Medivir | Results First interim results from a phase IIa study evaluating an all-oral regimen of Simeprevir and Sofosbuvir in prior null responder Hepatitis C patients medivir.com ↗
The regimen of once-daily simeprevir and sofosbuvir with or without ribavirin was generally well tolerated and no serious adverse events occurred during the treatment period for the patients involved in the study. |
| 2013-02-19 | Gilead Sciences | Results Gilead’s Sofosbuvir for Hepatitis C Meets Primary Endpoint in Fourth Pivotal Phase 3 Study gilead.com ↗
The study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response (SVR) rate of 25 percent. |
| 2013-02-04 | Gilead Sciences | Results Gilead Announces Sustained Virologic Response Rates from Two Phase 3 Studies of Sofosbuvir for Hepatitis C gilead.com ↗
All common adverse events (≥10 percent in any group) occurred more frequently in subjects receiving peg-IFN and RBV as compared to sofosbuvir and RBV. |
| 2013-01-07 | Gilead Sciences | Results Gilead Provides Update on Hepatitis C Development Programs gilead.com ↗
Sustained Virologic Response Achieved with Oral Regimen of Sofosbuvir, GS-5885 and Ribavirin in 9/9 Null Responder Genotype 1 Hepatitis C Patients |
| 2012-11-27 | Gilead Sciences | Results Gilead Announces Sustained Virologic Response Rate of 78% From Phase 3 Study of Sofosbuvir for Genotype 2/3 Hepatitis C Infected Patients gilead.com ↗
The study found that 78 percent of patients (n=161/207) remained HCV RNA undetectable 12 weeks after completing therapy (SVR12). |
| 2012-11-10 | Gilead Sciences | Results Gilead Announces 100 Percent Sustained Virologic Response Rate (SVR4) for an Interferon-Free Regimen of Sofosbuvir (GS-7977), GS-5885 and Ribavirin in Treatment-Naïve Genotype 1 Hepatitis C Infected Patients gilead.com ↗
Among treatment-naïve patients receiving this combination, 100 percent (n=25/25) remained HCV RNA undetectable four weeks after completing therapy (SVR4). |
| 2012-10-16 | Bristol-Myers Squibb | Results Bristol-Myers Squibb to Present New Data Demonstrating Company’s Continuing Commitment to Research and Development in Liver Disease at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting bms.com ↗
High Rate of Sustained Virologic Response with the All-Oral Combination of Daclatasvir (NS5A Inhibitor) Plus Sofosbuvir (Nucleotide NS5B inhibitor), With or Without Ribavirin, in Treatment-Naïve Patients Chronically Infected With HCV Genotype 1, 2, or 3 |
| 2012-04-19 | Gilead Sciences | Results Gilead Announces Sustained Virologic Response Data for 12-Week Regimen of GS-7977 Plus Pegylated Interferon and Ribavirin in Genotype 1 Hepatitis C Patients gilead.com ↗
At the end of treatment, 51/51 patients (100 percent) were HCV RNA undetectable. |
| 2012-04-19 | Gilead Sciences | Results Gilead Announces Early Sustained Virologic Response Rates for GS-7977 Plus Ribavirin in Genotype 1 Treatment-Naïve Hepatitis C Patients gilead.com ↗
Of the 25 patients who completed 12 weeks of treatment with the GS-7977-based regimen, 88 percent of patients (n=22/25) remained HCV RNA undetectable four weeks after completion of treatment. |
| 2012-04-19 | Bristol-Myers Squibb | Results All-Oral Combination of Investigational Hepatitis C (HCV) Compounds Daclatasvir and GS-7977 Achieved Sustained Virologic Response (SVR4) in 100% of Genotype 1 and 91% of Genotype 2 and 3 Treatment-Naïve Patients in Phase II Study bms.com ↗
In this interim analysis, a combination of the two oral, once-daily investigational compounds taken for 24 weeks, with or without ribavirin, achieved a rapid and sustained viral response. |
| 2012-02-17 | Gilead Sciences | Results Gilead Announces Data for Genotype 1 Null Responder Hepatitis C Patients Enrolled in ELECTRON Study gilead.com ↗
Among these eight patients, six have experienced viral relapse. |
All press releases naming this drug 120 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 120 releases opens the full record — a long page | ||
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 279 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sofosbuvir | “This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide...” NCT02707601 ↗252“The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for...” NCT02300103 ↗ “This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) +...” NCT02226549 ↗ “Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from...” NCT03062423 ↗ “Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir,...” PMID 27917405 ↗ Jul 2016 “After taking tenofovir alafenamide/emtricitabine for 12 weeks, participants will then start taking ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) in combination with the...” NCT03126370 ↗ “For hepatitis virus C genotype 1: sofosbuvir 400 mg + lepidavir 90 mg for 12 weeks OR sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks; For hepatitis virus C genotypes 2 and...” NCT03669835 ↗ “Participants will be treated with the pan-genotypic therapeutic regimen "single-pill daily," at a fixed dose and duration: sofosbuvir/velpatasvir 400/100 mg (Epclusa, Gilead...” NCT06306300 ↗ “patients with HCV genotype 2 were randomly assigned in a 1:1 ratio to receive sofosbuvir-velpatasvir, in a once-daily, fixed-dose combination tablet (134 patients), or...” PMID 26575258 ↗ Nov 2015 “This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated...” NCT01687257 ↗ “determine the bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) versus Sovaldi 400 mg F.C.T (Gilead Sciences, Ireland) in Healthy Human...” NCT02491450 ↗ |
| Known as | GS-7977 | “Sofosbuvir (formerly known as GS-7977) is a direct-acting nucleotide polymerase inhibitor that is being developed as an oral drug for the treatment of chronic HCV infection” NCT02804386 ↗ |
| Known as | Heterosofir | “determine the bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) versus Sovaldi 400 mg F.C.T (Gilead Sciences, Ireland) in Healthy Human...” NCT02491450 ↗ |
| Known as | PSI-7977 | “Sofosbuvir is also known as GS-7977 or PSI-7977.” NCT02125500 ↗ |
| Known as | Psi-7977, gs-7977 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1259059 ↗ |
| Known as | SOF | “This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) +...” NCT02226549 ↗62“The proposed study will quantify hepatic improvement and antiviral efficacy of the open-label interferon-free combination of 12 weeks of simeprevir (SMV, Simeprevir),...” NCT02455167 ↗ “METHODS: A subanalysis of efficacy and safety for a daclatasvir (DCV) and sofosbuvir (SOF) regimen, with or without ribavirin (RBV), was undertaken in HIV-HCV-coinfected...” PMID 27845298 ↗ Nov 2016 “This phase III study (ALLY-3; ClinicalTrials.gov: NCT02032901) evaluated the 12-week regimen of daclatasvir (DCV; pangenotypic nonstructural protein [NS]5A inhibitor) plus...” PMID 25614962 ↗ Mar 2015 “This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated...” NCT01687257 ↗ “containing the NS5B polymerase inhibitor sofosbuvir (SOF) 90 mg and the NS5A inhibitor ledipasvir (LDV) 400mg, marked a new era of IFN and ribavirin free, directly acting...” NCT02683005 ↗ “The C-ISLE study assessed the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) plus sofosbuvir (SOF) with and without ribavirin (RBV) in compensated cirrhotic participants...” PMID 29473975 ↗ Apr 2018 “sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.” NCT01858766 ↗ “The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)” NCT01909804 ↗ “This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.” NCT04387526 ↗ “This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3.” NCT02133131 ↗ |
| Known as | Sofosbuvir (GS-7977) | “Sofosbuvir (GS-7977)” NCT01805882 ↗ |
| Known as | Sofosbuvir component of epclusa | ChEMBL registry synonym — accepted as the source's own label CHEMBL1259059 ↗ |
| Known as | Sofosbuvir component of harvoni | ChEMBL registry synonym — accepted as the source's own label CHEMBL1259059 ↗ |
| Known as | Sofosbuvir component of vosevi | ChEMBL registry synonym — accepted as the source's own label CHEMBL1259059 ↗ |
| Known as | Solvaldi (Sofosbuvir); | “Solvaldi (Sofosbuvir);” NCT02455167 ↗ |
| Known as | Sovaldi | “Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per...” NCT03146741 ↗7“Sofosbuvir (SOVALDI®) is a nucleotide analog directed against HCV NS5B polymerase, clinically approved with potent antiviral effects on the hepatitis C virus with several genotypes21.” NCT04468087 ↗ “daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight” NCT04382339 ↗ “using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV).” NCT02455167 ↗ “treated with Sofosbuvir 400 mg (Sovaldi) + Daclatasvir 60mg (Daklinza) + Ribavirin 200 mg (Rebetol)” NCT03547895 ↗ “SOVALDI (Sofosbuvir) (400mg QD)” NCT02214420 ↗ “Sofosbuvir 400 MG [Sovaldi]” NCT03312023 ↗ “Sofosbuvir, Sovaldi” NCT02304159 ↗ |
| Known as | Sovaldi (sofosbuvir) | “Sovaldi (sofosbuvir)” NCT01532908 ↗ |
| Known as | Sovaldi is a trade name of sofosbuvir | “Sovaldi is a trade name of sofosbuvir” NCT04387539 ↗1“Sovaldi is a trade name of sofosbuvir” NCT04385407 ↗ |
| Action | Inhibit | “nucleotide polymerase inhibitor sofosbuvir” PMID 24262278 ↗ Nov 2013 |
| Modality | Small molecule | “sofosbuvir, a uridine nucleotide analogue” PMID 23499158 ↗ Mar 2013 |
| Route | Oral | “Sofosbuvir tablet(s) administered orally once daily” NCT01054729 ↗ |