Efficacy, Tolerability, and Safety of Direct Acting Anti-Viral
(Daa) Therapies in Octogenarian Patients with Chronic
Hepatitis C Infection Volume 2 - Issue 5
Ashamalla Michael*
Department of medicine, Albany medical college, USA
Received: January 29, 2020; Published: February 06, 2020
*Corresponding author: Ashamalla Michael, Department of medicine, Albany medical college, New York, USA
Our greater understanding of the Hepatitis C Virus (HCV)
genome has led to the development of multiple direct- acting
antivirals (DAAs) which are targeted medications at specific steps
of the HCV life cycle. Antiviral therapy has become the cornerstone
of treatment of chronic Hepatitis C (CHC) infection. With current
antiviral therapies, CHC is easily treated and can be eliminated
in almost all patients. The main targets of the DAAs are the HCVencoded
proteins that are vital to the replication of the virus. DAA
therapies are efficacious up to 95%, tolerable, and safe with a mild
side effect profile for the treatment of CHC. The clinical trials for
HCV regimens did not include patients 80 years and older. Although
widely used, there is limited data on their efficacy, tolerability,
and safety in an active octogenarian population. We studied the
outcomes of a cohort of 90 octogenarians treated by DAA for CHC.
We conducted a retrospective chart review of 1900 CHC
patients from December 1st, 2014 to September 20th, 2018 at a
tertiary medical center AND identified 90 patients aged 80 years
and older who were treated with DAA therapies. Our study inclusion
criteria were patients aged 80 and older who were treated for CHC.
Patients younger than 80 years of age were excluded from this
study. A comprehensive database was formulated to include all
demographic information, concurrent diseases and medications
while on DAA therapies [1,2].
The demographics of our study were divided between patients
in Group 1, aged 80-85 years old (n=51, 57%) and Group 2, aged 86
years and older (n=39, 43%), 47 (52%) of whom were Caucasian by
race. Of the total 90 identified patients, 48 (53%) were female and
42 (47%) were male. No significant adverse events were reported.
All patients underwent vibration control transient elastography
(fibroscan). Sustained virologic response (SVR) was achieved in all patients (100%) 12 weeks post treatment. The predominant HCV
genotype was 1b, seen in 60 patients (67%). Sixty-four patients
(71%) had a fibrosis score <F3 while 26 patients (29%) had F3-F4
disease [3,4]. Fifteen patients (17%) had compensated F4 disease
and no patients had decompensated F4 disease. While 21 patients
(23%) were treated with Interferon based therapy, the majority of
patients (n=69, 77%) were prior treatment naïve. The most common
side effects from DAAs include headache, fatigue, insomnia, nausea,
and diarrhea; none of which were reported among the 90 patients
evaluated in this study. Drug-drug interactions between DAAs
and several medication classes were closely examined including
HAART, statins, herbal medications, and PPIs. All 90 octogenarians
were HIV negative and were not treated with anti-retroviral agents.
Five patients (6%) were on a statin (Atorvastatin or Simvastatin)
and 31 patients (34%) were taking Cardiac medications (including
Amiodarone) prior to treatment with DAA therapies. No patients
were using herbal medications, other OTC’s, or PPI during
treatment [5,6].
The predominant DAA therapy utilized in our study was
Sofosbuvir/ Ledipasvir (n=72, 80%) while other patients were
treated with Sofosbuvir / Velpatasvir (n=13, 14%) and Elbasvir/
Grazoprevir (n=5, 6%). The transaminase levels pretreatment was
used to assess the effect of DAA therapies on liver tests. Abnormal
liver tests were present in all 90 patients prior to DAA therapy and
normalized post treatment. Kidney function pre and post treatment
showed no evidence of decrease in GFR in all cohorts. No patient
stopped treatment for any reason during therapy for any reason
(Tables 1 & 2).
All 90 patients achieved SVR post DAA therapies. DAA therapies
are safe and efficacious for use in octogenarian patients with CHC,
including those with compensated cirrhosis. Active octogenarians
should be considered for DAA therapies if there are no
contraindications to treatment. Our study is limited by sample size and few comorbidities. Larger series with diverse demographics
will further validate our understanding of the efficacy, tolerability,
and safety of DAA therapy in the Octogenarian population. We
encourage all health care providers to consider DAA therapy in this
population.