Médecins slams Gilead for licencing new hepatitis drug in India

The well-known international humanitarian organisation Médecins Sans Frontières has strongly criticised the decision by US-based Gilead Sciences to expand its existing voluntary licence agreement with eight Indian generic drug-makers for sofosbuvir and ledipasvir to include its investigational compound GS-5816, saying it will restrict access to the drugs for people across the developing world.

''Gilead's anti-diversion programme not only potentially jeopardises patient confidentiality and privacy, but could also exclude many patients that may lack the citizenship and identification papers that Gilead requires them to have in order to get access to treatment.

''Gilead's programme introduces coercion and policing upon medical providers and may result in treatment interruptions for patients, leading to treatment resistance and failure.  As far as is known to MSF, such a programme, motivated solely by commercial interests, is unprecedented,'' MSF said.

- See more at: http://www.domain-b.com/industry/pharma/20150128_hepatitis.html#sthash.REnGdQcH.dpuf

HCV Drugs —Alan Franciscus, Editor-in-Chief

AbbVie's VIEKIRA PAK Approval & AASLD 2014

In this month’s HCV Drugs we have news on AbbVie’s drug approval of their HCV drugs, and, yes, more coverage from the American Association for the Study of Liver Diseases (AASLD).  In Lucinda’s Snapshots column this month, information on Janssen’s AASLD presentations is included.

AbbVie
On December 19, 2014 the Food and Drug Administration (FDA) approved AbbVie’s 3D combination—VIEKIRA PAK—to treat HCV genotype 1 patients.   On December 23, 2014, the 3D combination was approved by Health Canada as HOLKIRA PAK. AbbVie conducted phase 3 trials in about 2,300 patients and the cure rates were over 90%.  Included in the FDA label was information about HIV/HCV coinfection and liver transplantation treatment results.  For more information, visit our website for new VIEKIRA PAK fact sheets, FDA Approved Prescribing Information and detailed information from their phase 3 studies included in past issues of our HCV Advocate monthly and mid-monthly newsletters. 

        VIEKIRA PAK

Gilead
GS-5816 is a new investigational NS5A inhibitor being developed by Gilead.  It has activity across all genotypes (pan-genotypic).  In the current studies, it is being combined with sofosbuvir (polymerase inhibitor) with and without ribavirin.

Safety and Efficacy of Treatment with Sofosbuvir plus GS-5816 With and Without Ribavirin for 8 or 12 Weeks in Treatment-Naïve Patients with Genotype 1-6 HCV Infection—T Tran et al.

Summary:  The combination of sofosbuvir plus GS-5816 without ribavirin produced high cure rates in all genotypes. 

Gilead continues to study sofosbuvir in combination with other investigational compounds—in this case with GS-5816, an NS5A inhibitor. 

Part A of the current study comprised 8 arms—all arms received sofosbuvir plus GS-5816 at either 25 mg or 100 mg without ribavirin for 12 weeks. Included in the study were treatment-naïve patients without cirrhosis.  There were two parts (A and B) of the study.  Part A had six treatment arms that included genotypes 1 through 6.  Listed below are the number of patients and cure rates. 

• Genotype 1:  55 patients:  96% to 100%
• Genotype 2:  21 patients: 91% to 100%
• Genotype 3:  54 patients 93%
• Genotype 4:  14 patients 86% to 100%
• Genotype 5:  1 patient 100%
• Genotype 6:  9 patients 100%

Part B of the study included only genotype 1 and 2 patients.  There were also 8 arms in Part B, but the genotype 1 non-cirrhotic patients received only 8 weeks of treatment at the same doses.  Half of the patients in the study received ribavirin.   Genotype, number of patients and cure rates are listed below:

• Genotype 1:  59 patients no ribavirin 83% to 87%; 61 patients (81% - 83%) with ribavirin
• Genotype 2:  52 patients no ribavirin 87% to 90%; 51 patients (88%) with ribavirin

The combination of sofosbuvir and GS-5816 with and without ribavirin was safe and well-tolerated.  The most common side effects were fatigue, headache, and nausea.

The combination of sofosbuvir (400 mg) and GS-5816 (100 mg) has been co-formulated into one pill taken once daily.  It is currently in phase 3 clinical trials to be studied with and without ribavirin for the treatment of HCV genotype 1, 2, 3, 4, 5, and 6.  

Comments:  Sofosbuvir and GS-5816 has been co-formulated into 1 pill taken once-a-day and is in phase 3 clinical trials with and without ribavirin for a treatment duration of 12 weeks for genotype 1 through 6.  Another study being conducted in genotype 3 patients is comparing the treatment duration of 12 vs. 24 weeks.

AASLD/ IDSA/IAS-USA Recommendations
Check out the updated HCV Guidance from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America that include Harvoni and VIEKERA PAK. Seven sections of the HCV Guidance have been extensively revised based on newly available therapies and data: Initial, Retreatment, Monitoring, and Unique Populations (HIV/HCV Coinfection, Cirrhosis, Post-Liver Transplantation, and Renal Impairment).
www.hcvguidelines.org


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