الفهرس 
IntroductionOnly 14 pages are availabe for public view
 |  | from | 148 |  |  |
| | | from | 148 | | |
Abstract
Background: Previous HCV antiviral drugs reported to cause ototoxicity
Aim of the study: To detect the effect of Sovaldi/ Daklinza regimen administration on vestibular & balance function.
Patients & Method:
30 adults HCV patients were assessed, before (Sovaldi/Daklinza) administration and three months after treatment using Vestibular office tests (Head shake test, Head thrust test, Fukuda steeping test & Modified Clinical Test of Sensory Integration for Balance (mCTSIB) ) , Videonystagmography (VNG), Sensory organization test (SOT) of Dynamic posturagraphy
Results: After treatment, all patients had normal vestibular office tests, normal VNG testing except for three patients (10% of the study sample) showed positional nystagmus after treatment that wasn’t present before receiving Sovaldi/Daclinza & normal balance function as demonstrated by SOT of Dynamic posturagraphy, with non-statistical significant difference between before and after treatment results.
Conclusions: Sovaldi/Daklinza regimen used in HCV treatment has no statistically significant effect on vestibular & balance function.
Key Words: Hepatitis C virus, Sovaldi/Daklinza, Vestibular & Balance
Introduction:
Hepatitis C virus infection (HCV) is a global health problem, with nearly 2 million new infections occurring every year and up to 85% of these becoming chronic infections that pose serious long term health risks (1)
Egypt has the highest known prevalence rate of HCV globally, with an estimated 14.7% of the total population seropositive for HCV (2),
With almost 10 million Egyptians exposed to the virus and about 5–7 million active infections.
The start of the epidemic in Egypt was attributed to the mass antischistosomiasis treatment campaigns that were conducted in the 1960s and 1970s using insufficiently sterilized intravenous injection equipment (3).
The goal of HCV treatment is to obtain a sustained virologic response (SVR), classically defined as undetectable HCV RNA 12 weeks or more following treatment completion (4).
Different categories of conventional interferon were known as a “key drug” to treat hepatitis C patient (5). Although, the addition of RBV and improvement of conventional interferon with pegylation had enhanced the rate of sustained virological response, yet most of the cases remained non-responders or relapsed after the termination, so there was a need to improve the long-term viral clearance rate with more effective and less side effects containing drug for hepatitis C patients (6)
Several new, all oral, interferon-free regimens are available and more are in development. Phase III drug trials of DAA regimens report cure rates consistently over 90% and significantly fewer adverse events compared with previous regimens (7). However, DAAs should not be administrated as monotherapy because this may lead to drug-resistance. (8)
Sofosbuvir (Sovaldi®) is a nucleotide analogue of HCV nonstructural protein NS5B inhibiting the virus RNA polymerase, in combination with other DAAs, is approved for the treatment of HCV infection of all genotypes (9), while Daclatasvir (Daklinza®) inhibits the NS5A protein and appears to act on viral replication, assembly and the secretion stages of the viral life cycle, thereby causing a rapid decline in both intra- and extracellular levels of HCV RNA.(10)
To the best of our knowledge, no studies have been conducted to evaluate the effect of Sovaldi/ Daklinza regimen on balance and vestibular function; however some studies were done to evaluate its effect on hearing.
Accordingly, this work was designed to study the effect of sofosbuvir in combination with Daclatasvir on vestibular and balance function in patients with chronic hepatitis C
Material and Methods:
This is a prospective study design that was carried on (30) patients, cases were recruited from the virology unit at eldemerdash hospital, Ain Shams University over a period of three months.
Inclusion Criteria:
Thirty adult HCV patients of grade (A) according to child pugh classification for liver disease severity between the age of 20 to 60 years old on (Sofosbuvir 400 mg/Dacltasavir 60 mg) daily for 3 months
Exclusion Criteria: Patients who had Previous interferon therapy or Decompensated (End stage liver disease), or any associated vestibular complaints
Equipments:
1- A double walled sound treated room I.A.C. model 1602.
2- Two channel Audiometer Interacoustics, model AC40, calibrated according to ANSI S.3.6, 1996.
3- Acoustic Immitancemeter MAICO model MI34.
4- Tools used for office tests:
A. Frenzel glasses for Head Shake and Head Impulse test.
B. Medium-density foam to conduct mCTSIB.
C. Stop watch for counting time in mCTSIB test.
5- Computerized four channel Video-nystagmography (VNG) michromedical Tech, meta4, software version4.5.
6- Computerized Dynamic Posturography (CPD) Neurocom international, equitest system, software version 8.4.