AbbVie:
TECHNIVIE:
On July 24, The Food and Drug Administration (FDA) approved the first interferon-free combination therapy to treat HCV genotype 4. The combination called TECHNIVIE (ombitasvir, paritaprevir and ritonavir) is taken with ribavirin and for 12 weeks. There was a total of 135 patients in the study—91 received TECHNIVIE with ribavirin and 41 received TECHNIVIE without ribavirin. None of the trial participants had cirrhosis. In the group that received TECHNIVIE with ribavirin there was a 100% cure rate; in the group that did not receive ribavirin there was a 91% cure rate. Since the study did not include people with cirrhosis the FDA did not approve TECHNIVIE for the treatment of genotype 4 with cirrhosis. AbbVie has indicated that there are on-going studies of genotype 4 cirrhotic patients and they will pursue an indication for cirrhotic patients on the TECHNIVIE product label.
On July 24, The Food and Drug Administration (FDA) approved the first interferon-free combination therapy to treat HCV genotype 4. The combination called TECHNIVIE (ombitasvir, paritaprevir and ritonavir) is taken with ribavirin and for 12 weeks. There was a total of 135 patients in the study—91 received TECHNIVIE with ribavirin and 41 received TECHNIVIE without ribavirin. None of the trial participants had cirrhosis. In the group that received TECHNIVIE with ribavirin there was a 100% cure rate; in the group that did not receive ribavirin there was a 91% cure rate. Since the study did not include people with cirrhosis the FDA did not approve TECHNIVIE for the treatment of genotype 4 with cirrhosis. AbbVie has indicated that there are on-going studies of genotype 4 cirrhotic patients and they will pursue an indication for cirrhotic patients on the TECHNIVIE product label.
Genotype 4 is uncommon in this country—the estimated prevalence is between 1.3% to 2.3%. There are some higher populations in areas around New York City, Los Angeles and Southern California estimated between 2 to 3%. Genotype 4 is the fourth most common genotype worldwide. It also accounts for 90% (6,030,000) of the hepatitis C population in Egypt. The remaining HCV population is genotype 1. The total HCV population of Egypt is 6.7 million.
Source: FDA Press Release (The total HCV population of Egypt is 6.7 million.
Be sure to check out our fact sheet on hepatitis C in Egypt: http://hcvadvocate.org/hepatitis/factsheets_pdf/HCAW_Egypt.pdf
New Combo:
A new phase 2 study of ombitasvir, paritaprevir and ritonavir—once-a-day combination of AbbVie drugs to treat 181 genotype 1b patients for a treatment period of 12 weeks ( without cirrhosis) or 24 weeks (with cirrhosis). The cure rates among the groups are listed below:
A new phase 2 study of ombitasvir, paritaprevir and ritonavir—once-a-day combination of AbbVie drugs to treat 181 genotype 1b patients for a treatment period of 12 weeks ( without cirrhosis) or 24 weeks (with cirrhosis). The cure rates among the groups are listed below:
- No-cirrhosis group: 95.2% cure rate among people who had never been treated (treatment naïve (42 patients); 90% cure rate among people who had been previously treated (treatment experienced (40 patients))
- Cirrhosis group: 97.9% cure rate among treatment naïve (47 patients); 96.2% cure rate in the treatment-experienced group (52 patients)
The most common side effects were headache, lack of energy, itching, and diarrhea. There was one treatment discontinuation due to treatment-related side effects.
This combination without interferon or ribavirin in a once-a-day pill for people with HCV genotype 1b would be a welcome addition to the landscape of hepatitis C treatment.
Source: Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir in an Open-label Study of Patients With Genotype 1b Chronic Hepatitis C Virus, With and Without Cirrhosis—Erica Lawtz– et al. http://dx.doi.org/10.1053/j.gastro.2015.07.001
Bristol-Myers Squibb
On July 24, 2015, the FDA approved BMS’s Daklinza (daclatasvir) in combination with Gilead’s sofosbuvir to treat HCV genotype 3. In the phase 3 studies of patients who were treated with Daklinza and sofosobuvir for 12 weeks the cure rates broken down by cirrhosis and prior treatment response are listed below:
- Without Cirrhosis: Treatment naïve—98%;
Treatment experienced—92% - With Cirrhosis: Treatment naïve—58%;
Treatment experienced—69%
The most common side effects were fatigue and headache.
The FDA press release noted that the response rates were reduced for HCV genotype 3 patients with cirrhosis. It should also be noted that the treatment duration is only 12 weeks as opposed to 24 weeks with the current standard of care—Sovaldi plus ribavirin. Still there is an unmet medical need for people with HCV genotype 3 with cirrhosis.
Source: FDA press release.
Merck
On July 28, 2015, Merck announced that the FDA had accepted their New Drug Application for grazoprevir/elbasvir for the treatment of HCV genotype 1, 4 and 6 infection. Merck has been granted Breakthrough Therapy designation for grazoprevir/elbasvir for the treatment of patients with HCV genotype 1 with end stage kidney disease who are on hemodialysis, and also for those patients with HCV genotype 4.
Merck
On July 28, 2015, Merck announced that the FDA had accepted their New Drug Application for grazoprevir/elbasvir for the treatment of HCV genotype 1, 4 and 6 infection. Merck has been granted Breakthrough Therapy designation for grazoprevir/elbasvir for the treatment of patients with HCV genotype 1 with end stage kidney disease who are on hemodialysis, and also for those patients with HCV genotype 4.
The cure rates for grazoprevir/elbasvir (one-pill/once-a-day) are impressive: genotype 1 up to 100%; genotype 4 up to 100% and up to 80% for genotype 6.
Merck stated that they expected a notification for drug approval from the FDA by January 28, 2016.
Source: Company press release
http://hcvadvocate.org/news/newsLetter/2015/advocate0815_mid.html#1
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