In part 2 of our European Association for the
Study of the Liver (EASL) coverage I will wrap up with a brief overview
of some of the remaining data.
Ombitasvir/Paritaprevir/Ritonavir for Treatment of HCV Genotype 1b In
Japanese Patients with or without Cirrhosis: Results from Gift-I –K Chayama et al
In this current study, Japanese
patients were treated with AbbVie’s 2D (paritaprevir/ritonavir plus
ombitasvir) given once-a-day for 12 weeks. This is different from the
3D regime given in the United States and elsewhere because Japanese
patients metabolize AbbVie’s drugs differently. With the 2D
combinations Japanese patients reach high enough levels even without
ribavirin or dasabuvir.
In the study there were 215 HCV
genotype 1b patients who received the study drugs, 42% were cirrhotic,
and 35% were treatment experienced. The overall cure rate was 95%.
The cure rates among those who had never been treated, as well as those
who were treated previously (cirrhotic and non-cirrhotic) were all
similar. The most common side effects were headache, edema and sore
has a long history of hepatitis C. AbbVie’s 2D combination will be a
welcome addition to the drugs in Japan to treat Japanese patients. For
more information about HCV in Japan check out our HCV in Japan
—HCV Around the World series.
Advanced Fibrosis is Common in Individuals whose Hepatitis C Has Not
Been Diagnosed: Results from the National Health and Nutrition
Examination Survey 2001-2012—P Udompap et al
This study has been reported at
previous conferences, but it is worth discussing again. The National
Health and Nutrition Examination Survey (NHANES) used data from a group
of 62,000 American adults of whom 45,000 were tested for hepatitis C
antibodies—591 tested antibody positive and of those 420 were HCV RNA
or viral load positive.
Of the 420 who had chronic
hepatitis C, 1 in 10 had cirrhosis and 1 in 5 had advanced fibrosis.
Approximately 50% did not know that they had hepatitis C.
validates the recommendation for “Baby Boomer” testing. This should
WAKE UP the complacency among physicians and associations and start
testing baby boomers NOW. We want to test, monitor, treat, cure and
Gilead: Ledipasvir/sofosbuvir treatment results in high SVR rates in patients with chronic genotype 4 and 5 HCV infection— A Abergel et al
A total of 44 HCV genotype 4
patients and 41 HCV genotype 5 patients were treated with the
combination of sofosbuvir and ledipasvir for 12 weeks. In both of the
groups the patients were evenly divided between treatment experienced
(TE) and those who had never been treated (TN) and those with and
without cirrhosis (C & w/o C). The cure rates in the HCV genotype
4 patients was TN =96% (21 of 22 pts); TE = 91% (20 of 22 pts); C=
100% (10 of 10 pts); w/o C = 91% (31 of 34 pts). The most common side
effects were fatigue and headache.
These are very good cure rates with few side effects. While the
population of genotype 4 and 5 in the United States is very
low—genotype 4 is very high in Egypt and other parts of the world (see HCV in Egypt
in our HCV Around the World series). Genotype 5 is primarily seen in
South Africa and parts of Europe. I will be writing an article on
Genotype 5 for the June Mid-Monthly edition so stay-tuned.
The Phase 3 C-Edge Treatment-Naive (TN) Study of a 12-Week Oral
Regimen of Grazoprevir (GZR, MK-5172)/Elbasvir (EBR, MK-8742) in
Patients with Chronic HCV Genotype (Gt) 1, 4, or 6 Infection—S Zeuzem et al
This was a phase 3 study of a
one pill, once-a-day grazoprevir and elbasvir pill taken for 12 weeks.
The study included treatment naïve (TN). The trial included a total of
421 infected HCV genotype 1, 4 or 6. Most of the trial participants
were male sex, and White. Ninety-one percent were genotype 1.
Approximately 22% had cirrhosis.
The overall cure rate was 95%:
92% for genotype 1a and 99% for genotype 1b; 100% (36 of 36 pts) of the
genotype 4 patients were cured; 80% (5 of 6 pts) of genotype 6
patients were cured. The most common side effects were headache,
fatigue, nausea and joint pain.
are high cure rates with a low side effect profile and it will make a
good addition to the treatment landscape of HCV in 2016. In people
with the genotype 1a NS5A resistance-associated variants (RAVs) it
shows greater than a 5-fold loss in sensitivity to elbasvir (a protease
inhibitor). What this means in clinical practice in unknown at this
Labels: AbbVie 2D, EASL 2015, GT4, Harvoni, Japan, Merck combo