Patients with chronic kidney disease (CKD) have a higher incidence of Hepatitis C Virus(HCV) infection compared to the general population. This is in large part due to the increased risk of HCV transmission associated with multiple blood transfusions and chronic dialysis therapy.
can cause kidney injury from viral protein/immune complexes blocking the normal
filtering capacity of the kidneys, so HCV can either be a cause or complication
of CKD. HCV infection in CKD patients is associated with a poorer overall
survival, the development of liver cirrhosis and poorer outcomes after kidney
transplant compared to transplant recipients without HCV infection.
infection among Indian CKD patients on dialysis is a significant problem, with at
least 27.7% of all Indian dialysis patients being HCV-antibody positive. These
patients need to spend longer periods of time on the dialysis machine, have
more dialysis related complications and have a poorer long-term survival.
Recent Study on HCV Treatment in CKD Patients
advances in HCV treatment options have led to a number of medications that can
completely cure HCV in the majority of patients, representing several major
breakthroughs in the treatment of this dreaded disease. A recent study from the
drug company Merck has announced a 99% cure rate of HCV in patients with CKD
using the once daily combination of the antiviral
grazoprevir and elbasvir.
This Phase 2/3 Trial (a fast-track study design combining safety and efficacy
investigations) has yet to be accepted in a peer reviewed scientific journal,
but preliminary data were presented as a poster at the European Association for
the Study of the Liver (EASL) 50th
International Liver Conference in
April 2015 in Vienna, Austria.
is important to note that the study drugs grazoprevir (an NS3/4A protease
inhibitor) and elbasvir (an NS5A replication complex inhibitor) are not yet FDA
approved for commercial human use, but the preliminary favorable results and
absence of significant drug side effects are very promising for patients with
CKD who are infected with HCV.
study enrolled 224 patients with CKD (18% Stage 4, 82% Stage 5, of whom 75%
were on dialysis) and grouped them into an immediate treatment group (n=111)
and a deferred treatment group (n=113), the latter group receiving a placebo
for 12 weeks followed by treatment. A total of 116 patients were included in
the final efficacy analysis and 115 (99%) achieved a "sustained viral response"
(SVR, or absence of detectable virus in the bloodstream) after 12 weeks of
therapy). The study was confined to patients with HCV Genotype 1.
effects occurred in about 15% of study participants and included headache,
nausea and fatigue. Only 3 participants dropped out of the study due to adverse
preliminary, the results of this study—the first to systematically study
treatment of HCV in CKD patients—demonstrate that this difficult patient
population can be successfully treated to eradicate detectable virus with
minimal side effects. If treatment with HCV antiviral medicines is initiated
early, the potential exists to prevent end stage kidney disease
caused by HCV.
Furthermore, kidney and liver transplant patients with HCV can now be expected
to have improved outcomes if HCV is eradicated before or shortly after
Chronic Kidney Disease (CKD) Stage:
Degree of kidney damage and reduction of normal function in patients with
chronic kidney disease. Stage 5 is end-stage damage, requiring dialysis or kidney transplant
The genetic code that defines a subtype of virus. For example, HCV has 6 major
genotypes and several subtypes (1a, 1b, 2a, 2b, etc.) each having their own
clinical behavior and response to treatments. Genotype 1 is the most common in
the U.S. and is the most difficult to treat. In India, Genotype 3 is the most
common and is relatively easier to treat.
Sustained Viral Response (SVR):
Absence of detectable HCV in the bloodstream of patients 12 weeks to 6 months
after a successful course of HCV antiviral medicine(s).
Phase 2/3 Clinical Trial:
a fast-track study design
combining safety and efficacy investigations.