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Alan Franciscus


HCV Advocate

Showing posts with label Sofosbuvir. Show all posts
Showing posts with label Sofosbuvir. Show all posts

Thursday, November 5, 2015

International Advisory Group Assesses Hepatitis C Elimination Program

A conference of international advisers has been held in the frames of the Hepatitis C Elimination Program of Georgia. The international partners will support and carry out consultations for implementing long-term strategies in monitoring, prevention and controlling systems.

The International Advisory Group, whose members are the heads of the US Center for Disease Control and Prevention, Emory and Hopkins Universities, World Health Organization and other international partners, attended the conference. They aim to encourage development of Hepatitis C elimination and also to increase public awareness.

The results of the Hepatitis C Elimination Program and its current conditions were discussed. According to the Ministry of Healthcare, 130-150 million people suffer from Hepatitis C and, in the WHO’s criteria, Georgia is considered as a high-prevalence country

Read more....

Thursday, October 29, 2015

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection. The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for patients with decompensated cirrhosis.

“As the first fixed-dose combination of two pan-genotypic, direct-acting antivirals, SOF/VEL represents an important step forward in the treatment of patients with hepatitis C,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “Genotype 1 is the most prevalent form of HCV in the United States, but worldwide, more than half of people living with HCV are infected with other genotypes. SOF/VEL complements our current HCV portfolio of Sovaldi and Harvoni, offering high cure rates and the potential to simplify treatment and eliminate the need for HCV genotype testing.”

The FDA has assigned SOF/VEL a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The NDA for SOF/VEL is supported by data from four Phase 3 ASTRAL trials, which evaluated the fixed-dose combination in hepatitis C genotypes 1-6. Of the 1,035 patients treated with SOF/VEL for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved the primary efficacy endpoint of SVR12. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. Those who received SOF/VEL plus RBV for 12 weeks achieved an SVR12 rate of 94 percent,while those who received SOF/VEL for 12 weeks and 24 weeks achieved SVR12 rates of 83 percent and 86 percent, respectively.

Read more....

Tuesday, October 13, 2015

SNAPSHOTS —Alan Franciscus, Editor-in-Chief

This month’s (October 2015) column features a variety of studies, including treatment of people with advanced liver disease, treating people who have not achieved a cure with direct acting antiviral therapy, including people who had developed RAVs.

Article:  Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease—M Charlton et al. 

Source:  Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.

Results and Conclusions
This was a phase 2 study of 337 patients with decompensated cirrhosis with genotype 1 (332 patients) and genotype 4 (5 patients) who received 12 or 24 weeks of Harvoni plus ribavirin twice daily.  None of the patients previously treated developed resistance to sofosbuvir.  People who had been previously treated with an NS5A inhibitor were excluded from the study. 

There were two groups in the study:
  •  Group A, who had NOT had a liver transplant: 59 patients with Child-Pugh class B cirrhosis and 49 patients with Child-Pugh class C  cirrhosis*
  •  Group B who HAD undergone liver transplantation:  111 patients without cirrhosis, 51 patients with Child-Pugh class A cirrhosis, 52 with Child-Pugh class B cirrhosis, 9 with Child-Pugh class C cirrhosis, and 6 with fibrosing cholestatic hepatitis*

 *Child-Pugh cirrhosis scoring is a system that uses various types of blood markers and liver disease progression such as ascites to evaluate a patient to establish the severity of cirrhosis and long-term patient survival.  The classes are A, B and C with A as the less severe and C as the most severe.  Cholestatic hepatitis is bile duct blockage with fibrosis.

Group A and B had 12- and 24-week treatment arms, but cure rates were similar regardless of treatment duration.
 The Bottom Line
In group A (those who had not received a liver transplant), the cure rate was 86% to 89%.  In group B (transplant group) the people who did not have cirrhosis or Class A cirrhosis—the cure rate was 96% to 98%.  Furthermore, in group B with class B cirrhosis (compensated) the cure rate was 85% to 88%, and those with class C cirrhosis (moderate impairment) achieved 60% to 75% cure rates. The people who had fibrosing cholestatic hepatitis achieved 100% cure rates.  There were 13 patients (4%) who discontinued treatment.  Ten patients died in the trial.  The deaths were mainly attributed to complications from hepatic decompensation or end-stage liver disease.

Editorial Comment
In the past, people with these types of severe disease progression have been very difficult to cure or even treat, but now with these ‘miracle’ drugs many people now have a second chance at life.  Now if we could just get these drugs to everyone with hepatitis C before this stage, we would eliminate the need to treat at these stages of disease severity. 


Article:  Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent—X Forns et al.

Source:  J Hepatol. 2015 Sep;63(3):564-72. doi: 10.1016/j.jhep.2015.04.009. Epub 2015 Apr 18.

Results and Conclusions
There were 79 HCV genotype 1 patients in the study. 
  • Sixty-six patients who had been previously treated patients with an NS3/4A protease inhibitor but had not been cured. 
  • Of the 13 remaining patients, 12 had discontinued treatment due to side-effect(s). 
  • Thirty-four patients had NS3 resistance-associated variants (RAVs), and eight patients had NS5A RAVs. 
  • Eight patients treated with the combination of grazoprevir and elbasvir plus ribavirin twice daily.

 The Bottom Line
The overall cure rates were 96% (76 of 79 patients)—this included 93% (63 of 66 patients) of the genotype 1a, one hundred percent of the patients (43 of 43 patients) who DID NOT have RAVs achieved a cure.  Ninety-one percent of those who DID have NS3 RAV’s were cured and 75% (6 of 8 patients) of those who had NS5A RAVs were cured.  Of those with cirrhosis 94% were cured with this combination. 

Editorial Comment
The addition of ribavirin to grazoprevir and elbasvir works to help cure resistance-associated variants in people who have been previously treated but who have not been cured.  It is also good strategy to treat other negative predictors to current  medications.

Article:  Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens—D Wyles et al.  

Source:  Hepatology. 2015 Jun;61(6):1793-7. doi: 10.1002/hep.27814. Epub 2015 Apr 27.

Results and Conclusions
There were 51 genotype 1 patients enrolled in the study (Note: one patient was incorrectly typed as genotype 1, but was subsequently correctly genotyped as genotype 3).  All of the patients in this trial were previously treated with a sofosbuvir containing regimes in Gilead’s phase 1 or phase 2 studies.  The treatment duration in this study was 12 weeks. 
Breaking it down by type of prior type of non-response:
  • 25 pts (49%) had previously received sofosbuvir plus pegylated interferon plus ribavirin
  • 20 pts (39%) had previously received sofosbuvir plus ribavirin
  • 5 pts (10%) received sofosbuvir (sugar pill/placebo) plus pegylated interferon and ribavirin
  • 1 pt (2%) received GS-0938 only fourteen patients (27%) had compensated cirrhosis.

 The Bottom Line
The total number of patients who achieved a cure was 98% (50 of 51 patients).  Among those who had received a prior course of sofosbuvir 98% (44 of 45) were cured.  The only patient who did not achieve a cure was the patient who was originally misdiagnosed as a genotype 1. 

The most common side effects were fatigue, headache and diarrhea.  The patients in this trial are considered some the most difficult to treat—those who have not achieved a cure with a previous course of a direct acting antiviral medication, those with cirrhosis, and people with resistant antiviral variants (RAVs). 

Editorial Comment
The addition of ledipasvir and ribavirin to sofosbuvir increased the cure rates to 100% for genotype 1.  Excellent results!  This is a good strategy with another type of direct acting antiviral to stop the virus from replicating and escaping.

Gilead, Merck, AbbVie, Janssen, and Achillion are working on other HCV drugs that have a higher barrier to resistance to avoid the development of resistance and to work for people who are not responding to the current medications.

Tuesday, October 6, 2015

U.S. FDA Grants Priority Review For Daklinza (daclatasvir) sNDA

Three applications are under review for Daklinzain combination with sofosbuvir with or without ribavirin to treat chronic hepatitis C patients with decompensated cirrhosis, post-liver transplant recurrence of HCV, and coinfection with HIV-1

Bristol-Myers Squibb’s U.S. registration focus for Daklinza is based on addressing the treatment needs of challenging HCV patient populations

October 06, 2015 07:00 AM Eastern Daylight Time

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review three supplemental New Drug Applications (sNDAs) for Daklinza (daclatasvir), an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin. The applications are for the treatment of patients with chronic hepatitis C (HCV) coinfected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.

In the U.S., the FDA grants priority review status when an investigational medicine, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. The FDA will review the three Daklinza sNDAs within a six-month timeframe.

“Hepatitis C is not a one-size-fits-all, monolithic disease. Our focus for the Daklinza-sofosbuvir regimen centers on addressing the needs of HCV patient subpopulations who need new options even in light of the extraordinary advances that have occurred in HCV treatment,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “We look forward to working with the FDA toward the goal of eventually helping many difficult-to-treat HCV patients.”

Daklinza was initially approved in the U.S. in July 2015 and is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. The new sNDAs accepted by the FDA for review include data from the ALLY-1 and ALLY-2 clinical trials. ALLY-2 evaluated the once-daily 12-week combination of Daklinza and sofosbuvir for the treatment of patients with HCV coinfected with HIV-1, a patient population that historically has been challenging to treat, in large part due to the complexities of the overlapping therapeutic regimens used to treat each infection. ALLY-1 evaluated a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with HCV with either advanced cirrhosis or post-liver transplant recurrence of HCV.

In May 2015, Daklinza with sofosbuvir received FDA Breakthrough Therapy Designation for HCV genotype 1 patients with advanced cirrhosis (Child-Pugh Class B or C) and those who develop genotype 1 HCV recurrence post-liver transplant. Breakthrough Therapy Designation, according to the FDA, is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for this designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

About Bristol-Myers Squibb in HCV

Bristol-Myers Squibb’s research efforts are focused on advancing compounds to deliver the most value to HCV patients with high unmet needs. At the core of our portfolio is Daklinza, a NS5A complex inhibitor which continues to be investigated in multiple treatment regimens and in patients with high disease burden.

In July 2014, Japan became the first country in the world to approve the use of a daclatasvir-based regimen for the treatment of chronic HCV. Since then, daclatasvir-based regimens have been approved in more than 50 countries, including the United States, across Europe, and in numerous other countries in Central and South America, the Middle East and the Asia-Pacific region.

Indication and Important Safety Information - Daklinza™ (daclatasvir)


Daklinza™ (daclatasvir) is indicated for use with sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection.

Limitations of Use:

Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving Daklinza in combination with sofosbuvir for 12 weeks.



Drugs Contraindicated with Daklinza: strong inducers of CYP3A that may lead to loss of efficacy of Daklinza include, but are not limited to:
Phenytoin, carbamazepine, rifampin, St. John’s wort (Hypericum perforatum).


-- Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: Coadministration of Daklinza and other drugs may result in known or potentially significant drug interactions. Interactions may include the loss of therapeutic effect of Daklinza and possible development of resistance, dosage adjustments for other agents or Daklinza, possible clinically significant adverse events from greater exposure for the other agents or Daklinza.

Serious Symptomatic Bradycardia When Coadministered with Sofosbuvir and Amiodarone: Post-marketing cases of symptomatic bradycardia and cases requiring pacemaker intervention have been reported when amiodarone is coadministered with sofosbuvir in combination with another direct-acting antiviral, including Daklinza. A fatal cardiac arrest was reported with ledipasvir/sofosbuvir.
Coadministration of amiodarone with Daklinza in combination with sofosbuvir is not recommended. For patients taking amiodarone who have no alternative treatment options, patients should undergo cardiac monitoring, as outlined in Section 5.2 of the prescribing information.
Bradycardia generally resolved after discontinuation of HCV treatment.
Patients also taking beta blockers or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone.


The most common adverse reactions were (≥ 5%): headache (14%), fatigue (14%), nausea (8%), and diarrhea (5%).


CYP3A: Daklinza is a substrate. Moderate or strong inducers may decrease plasma levels and effect of Daklinza. Strong inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, ritonavir) may increase plasma levels of Daklinza.
P-gp, OATP 1B1 and 1B3, and BCRP: Daklinza is an inhibitor, and may increase exposure to substrates, potentially increasing or prolonging their adverse effect.
See Section 7 of the Full Prescribing Information for additional established and other potentially significant drug interactions and related dose modification recommendations.

Daklinza in Pregnancy: No data with Daklinza in pregnant women are available to inform a drug-associated risk. Animal studies of Daklinza at exposure above the recommended human dose have shown maternal and embryofetal toxicity. Consider the benefits and risks of Daklinza when prescribing Daklinza to a pregnant woman.

Nursing Mothers: Daklinza was excreted into the milk of lactating rats; it is not known if Daklinza is excreted into human milk. Consider the benefits and risks to the mother and infant when breastfeeding.

Please click here for the Daklinza full prescribing information.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information please visit www.bms.com or follow us on Twitter at twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Daklinza will be approved for the additional indication mentioned above. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Bristol-Myers Squibb Company
Robert Perry, 609-419-5378
cell: 407-492-4616
Ranya Dajani, 609-252-5330
Bill Szablewski, 609-252-5894

Monday, September 28, 2015

September 2015 Mid-Month Edition - SNAPSHOTS —Alan Franciscus, Editor-in-Chief

This month’s Snapshots is about recently published studies on all-oral therapies to treat hepatitis C in people coinfected with HIV.  We have really come a long way in such a short period of time with medications to treat a population in high need of effective therapies.    

Article: Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1—S Naggie et al.

Source:  New England Journal of Medicine DOI: 10.1056/NEJMoa1501315

Results and Conclusions
The study included 335 patients coinfected with HIV-1 and hepatitis C genotype 1 or 4.  The median age was 52 yo (48-58 yo).  The majority of patients were White 61% (203 pts) and Black 34% (115 pts), male 82% (276), genotype 1a 75%, genotype 4 two percent, cirrhosis 20%, median CD 4+ cell count 628 (469-823), treatment naïve 45%, previously treated 55%. The treatment period was 12 weeks.  Note: I am not including the genotype 4 patients since there were only 8 patients.  

The Bottom Line
The cure rates were 96% for genotype 1a, and 96% for genotype 1b. The cure rates were similar regardless of prior response or degree of liver damage.  The most common side effects were headache, fatigue and diarrhea.  No patients discontinued treatment due to side effects.

Editorial Comment
These results are excellent across subtypes (1a/1b), races, and prior treatment responses.  Gilead has filed for marketing approval with the Food and Drug Administration.  The American Association for the Study of Liver Disease (AASLD) and the Infectious Disease Society of America (IDSA) recommend Harvoni as a treatment for HCV for people coinfected with HIV and hepatitis C.


Article: Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial—J K Rockstroh, et al

Source:  The Lancet HIV Volume 2, No. 8, e319–e327, August 2015

Results and Conclusions
The study was conducted in people with HIV/HCV coinfection to evaluate grazoprevir/elbasvir (one pill, once-a-day) to treat HCV genotype 1, 4, and 6. The treatment period was 12 weeks. There were 218 patients in the phase 3 trial.  The trial was conducted in Europe, the United States and Australia.

The Bottom Line
The overall cure rate was 96% (210 of 218 patients).  All patients who had cirrhosis were cured.  The most common side effects were fatigue, headache and nausea. No patients discontinued treatment due to side effects.

Editorial Comment
The high cure rates and fewer side effects plus no treatment discontinuation due to treatment-related side effects equals very good news for patients.

The once-a-day combination of grazoprevir/elbasvir when approved is going to be a welcome addition to the other therapies to treat hepatitis C in people who are HIV and HCV coinfected.  


Article: Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1—D L Wyles et al.  
Source:  New England Journal of Medicine DOI: 10.1056/NEJMoa1503153

Results and Conclusions
There were 3 different treatment groups. All the groups received daclatasvir plus sofosbuvir. Note: Since there was a small number of genotype 2, 3, and 4 patients—I omitted these results.  For this article I am just listing the genotype 1 results.    

The Bottom Line
The patient characteristics, treatment durations and cure rates are included below:

  1. Naïve (untreated patients): 101 patients; median age 52 yo; male sex 91%; race: White 65%, Black 30%; genotype 1a: 70%, genotype 1b: 12%; cirrhosis 9%; median CD4+ count 520 (122-1147). Treatment duration = 12 weeks. Cure rate = 96%
  2. Naïve (untreated patients): 50 patients; median age 51 yo; male 84%; race White 56%, Black 38%; Genotype 1a 70%, Genotype 1b 12%; cirrhosis 10%; treatment duration = 8 weeks.  Cure rate = 76%
  3. Treatment Experienced:  52 patients; median age 57 yo; male 83%; race White 60%, Black 38%; genotype 1a 63%, genotype 1b 21%; cirrhosis 29%; treatment duration =12 weeks.  Cure rate = 98%

The most common side effects were fatigue, nausea, and headache.  No patient discontinued due to side effects.

Editorial Comment
The 12-week treatment groups had good cure rates as opposed to the 8-week treatment response group.  The treatment-experienced group #3 with a 38% Black population and a relatively high cirrhotic population achieved nearly perfect cure rates. The drawback of this combination is going to be the high price tag of the combination of these two drugs.

Note:  Another issue with treating hepatitis C in people with HIV is the potential drug-drug interactions with HIV medications.  For more information visit the AASLD/IDSA  HCV Guidelines http://www.hcvguidelines.org/full-report-view.

Wednesday, September 9, 2015

Sovaldi-Based Hep C Regimens Less Successful in Real World

The real-world cure rates offered by Sovaldi (sofosbuvir)–based hepatitis C virus (HCV) regimens have not been as good as those seen in clinical trials, at least among a group of veterans with genotypes 1 or 2, Healio reports. Publishing their findings in Alimentary Pharmacology & Therapeutics, researchers analyzed data from the Veterans Affairs Clinical Case Registry for HCV on 4,026 vets treated for hep C with 12-week Sovaldi–based regimens.

A total of 3,203 of the vets had genotype 1 and 823 had genotype 2.

Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) has superseded Sovaldi–based regimens (Sovaldi is also a Gilead drug) as the treatment of choice for those with genotype 1. So this study’s findings may not be applicable to the current realities of hep C treatment among that group, especially since this study looked in part at the results of regimens including interferon, which causes flu-like side effects. Interferon has largely been edged out of the hep C arsenal.

However, 12 weeks of Sovaldi plus ribavirin is still the top-recommended regimen for treatment-naive people with genotype 2, which makes  this study more relevant to that population’s current concerns.


Tuesday, September 8, 2015

Iran: Hepatitis C drug to be released

TEHRAN, Sep. 08 (MNA) – Deputy health minister has reported on the entry of home-made Hepatitis C drug to the country’s pharmaceutical market next week noting that it has been produced by Iranian knowledge-based companies.

“The Sofosbuvir drug is used to treat hepatitis C cases; previously it was imported from other countries and priced at $100 per tablet but the indigenous version will be available at the price of 10 dollars per tablet,” said Reza Malekzadeh at a press conference on knowledge-based companies reminding that, “in terms of quality, this drug fully complies with foreign ones and there is no difference in terms of efficiency or treatment of the disease.”

He also reported the production of two other combination drugs to treat hepatitis C in the country adding that they are currently at laboratory stage and will soon be released. “There are now drugs that can treat hepatitis C and there exists the possibility of eradication of the hepatitis C virus in the country in near future; hepatitis C has a three-month course of treatment and patients should take one tablet per day for full treatment,” added Malekzadeh.


Wednesday, March 18, 2015

Zydus, Gilead Sciences, SoviHep, Sofosbuvir, Ledipasvir, HCV, Liver Gilead Sciences And Zydus Launch SoviHep Hepatitis C Drug

American biotechnology firm Gilead Sciences and Indian pharmaceutical company Zydus launched SoviHep, a drug for treating Hepatitis C.

On Tuesday, March 17, Zydus issued a statement that confirmed it has signed a non-exclusive agreement with Gilead Sciences, which will enable the company to manufacture sofosbuvir, trade name SoviHep, as well as fixed-dose combination of sofosbuvir/ ledipasvir for circulation in more than 90 countries, which includes India. The drug will be marketed by Zydus Heptiza, which is a specialty division in the group.

Hepatitis C may affect the quality of life for patients. Pankaj Patel, Managing Director and Chairman of the Zydus Group, reveals that the launch of SoviHep will provide better treatment for the disease and improve the quality of life for millions of people.


Wednesday, March 4, 2015

Montreal-Hepatitis C cure rate of 97 per cent announced in study of patients co-infected with HIV given 12-week combination

MONTREAL, March 3, 2015 /CNW/ - A combination of two once-daily medications for chronic hepatitis C infection has been shown in newly released study results to cure almost all the patients who participated, despite the patients also being co-infected with human immunodeficiency virus (HIV). This patient population historically has been challenging to treat for hepatitis C, in large part due to potential drug-drug interactions between the antiviral therapy regimens used to treat each infection.

Results of ALLY-2, a Phase 3 clinical trial evaluating the investigational once-daily combination of daclatasvir and sofosbuvir for the treatment of chronic hepatitis C in patients co-infected with HIV were announced last week and showed that those treated for 12 weeks (HCV treatment-naïve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment, or SVR12). 
"The data showed results that are very promising in patients that are well known as being both difficult to treat and at higher risk for developing serious liver disease, making the results all the more significant," said Dr. Stephen Shafran, Professor of Medicine (Infectious Diseases) at the University of Alberta. "It's also important to note that we are seeing high cure rates with the daclatasvir and sofosbuvir combination regardless of the genotype of the hepatitis C infection."

Thursday, February 19, 2015

Portugal: Hepatitis C treatment 100% subsidised

Innovative drug, Sofosbuvir, to treat hepatitis C is 100% subsidised in Portugal since Tuesday evening and will be given to all patients who need it.

Eurico Castro Alves was speaking at the end of a meeting with the administrators of all hospital that treat hepatitis C in Portugal, Infarmed and the secretary of state of health.

Alves said that an agreement had been signed with the laboratory that makes Sofosbuvir and the drug is now 100% state subsidised.

The Infarmed chairman said that all patients who needed the treatment would receive the drug and added that there are currently 602 receiving Sofosbuvir.


Hepatitis C drug patent challenged in Europe

A French healthcare campaign group has launched a legal challenge to the patent covering Sovaldi (sofosbuvir), the blockbuster hepatitis C virus (HCV) drug marketed by Gilead. Médecins du Monde (MDM) has told the European Patent Office (EPO) ‘the molecule itself is not sufficiently innovative to warrant a patent’.

HCV infection can clear within a few months. But for about 80% of those infected, it develops into a chronic condition. According to the World Health Organization, 130–150 million people are living with chronic HCV infection.


Tuesday, January 20, 2015

TAC, SECTION27 and MSF Applaud India’s Rejection of Patent on New Hepatitis C Medicine

JOHANNESBURG, Tuesday 20th January: The Treatment Action Campaign (TAC), Doctors Without Borders (MSF) and SECTION27 applaud India’s decision to reject a patent application on sofosbuvir, an important new treatment for Hepatitis C. Last Wednesday’s decision paves the way for increased access to more affordable sofosbuvir in India and other countries who choose to implement legal flexibilities available under international law to increase access to the drug. However, existing patents on sofosbuvir in South Africa could block access to the cheaper generic versions that will become available due to the ruling.  The government should therefore urgently finalise the national intellectual property policy to allow South Africa to better protect access to medicines.

Rejection of the patent in India will allow generic manufacturers that have not already signed restrictive licensing agreements with Gilead to produce sofosbuvir at much lower prices than currently available. Research conducted by Dr Andrew Hill at the University of Liverpool, for example, suggests that sofosbuvir can be profitably produced for as little as $102 (R1,182) per 12 week course.

However, patent protection in South Africa prevents open competition, and could block generic versions of sofosbuvir and other new HCV drugs from reaching the domestic market. The same sofosbuvir patent rejected in India was granted in South Africa, and will only expire in 2025. South Africa has also granted multiple ‘secondary’ patents on sofosbuvir, with the latest patent only expiring in 2034. If reforms proposed in South Africa’s draft intellectual property policy are implemented, the number of such secondary patents granted will be dramatically reduced.


Wednesday, January 14, 2015

Key Hepatitis C Patent Rejected In India For Lack Of Novelty, Inventive Step

Today’s rejection by the Patent Office Controller of India of a patent application by Gilead company for a key drug against hepatitis C is being hailed by advocates as a path to dramatically lower costs of treatment for the disease. Hepatitis C has made news for the emergence of exorbitantly priced medicines over the past year. A look at the decision shows that a provision in India’s law continues to stop patent applications if they fail to show sufficient novelty and inventive step – and are subject to opposition.

The patent office decision dated 13 January is available here [pdf].

The decision states that oppositions to several patent applications on sofosbuvir were filed by the Initiative for Medicines, Access & Knowledge (I-MAK), and the Delhi Network of Positive People (DNP+), in November 2013 and March 2014, arguing that they were not sufficiently novel and inventive as required for a patent. Gilead then made arguments explaining why these oppositions were not valid.