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.
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.
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:
- 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.
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 Labels: HCV Drugs, Technivie