During the Era of Pandemic Corona Virus Disease 19, is Telemedicine Effective in the ‎follow-up of Hepatitis C Virus Patients Receiving Direct anti-Viral Therapy?‎‎

INTRODUCTION

A new severe acute respiratory syndrome corona virus outbreak has led to corona virus disease 2019 which has begun in Wuhan city in December 2019, then has rapidly spread throughout China and became worldwide[1]. The World Health Organization (WHO) has declared that COVID-19 is a pandemic infectious disease that was on 11 March 2020, and the number of confirmed COVID-19 cases has increased to more than 372000 globally by 24 March 2020 [2].

About 1099 patients were diagnosed as COVID-19 from Wuhan city were studied and showed that typical clinical spectrum of symptoms of COVID- 2019 included fever, sore throat, fatigue, cough, and shortness of breath. Over 40% of patients had had a history of contact with confirmed COVID-19 cases and 56.2% didn’t have history of fever [3]. Gastrointestinal symptoms of COVID-19 were less common when compared with SARS or MERS [4, 5]. The overall mortality was about 1.4%, and the mortality increases with the severity of cases up to 22.4% in more complicated cases [6, 7].

There are over 185 million worldwide are infected with chronic hepatitis c virus (HCV), which is considered a known cause of chronic liver disease and its life threatening medical burdens such as liver cell failure, portal hypertension and hepatocellular carcinoma within 10 to 30 years [8].

Technology has become as a great enabler of patient continuity through remote medical consultation, ongoing monitoring, and patient education using telephone and videoconferencing in the COVID-19 era [10].

In this study, we want to assess retrospectively patients who received anti- HCV treatment and were followed via telemedicine and different communications methods during this current era of COVID- 19 in 2020.

PATIENTS AND METHODS

This current retrospective study has included 300 naive chronic HCV patients  who asked for medical advice at viral hepatitis clinic,  Minia university hospital,  Egypt, were treated with sofosbouvir 400 mg, daclatasvir 60 mg for 12 weeks. 150 chronic HCV naive patients were treated during the period of 2019 and were followed by regular routine visits during the treatment (routine classical group). Another 150 cross matched chronic HCV naïve patients during 2020 after beginning of the era of COVID 19 (telemedicine group). Patients were included in the study according to the following criteria (positive HCV RNA, age is ranging from 18 to 65 years, and treatment naïve patients).  Exclusion criteria from the study if patients had any of the following : treatment experienced patients, patients with current or previously treated  hepatocellular carcinoma, extra-hepatic malignancy, liver transplanted patients, patients with  severe extra-hepatic manifestations, pregnancy, or inability to use effective contraception, poorly controlled diabetes mellitus, patients suffering from advanced kidney disease, and  patients with child B or C liver cirrhosis. Patients were subjected before treatment to detailed medical history including treatment of accompanying chronic medical comorbid diseases, meticulous clinical examination, assessment of body mass index and  laboratory measures including HCV antibodies using the ELISA technique, HCV RNA quantitative PCR before treatment, follow-up at the end of treatment and at 12 weeks after the end of treatment, liver function tests including aspartate aminotransferase, alanine aminotransferase,  international normalized ratio, serum albumin, total and direct serum bilirubin, plus  HBs Ag, HIV antibody by ELISA, complete blood count, fasting blood glucose, and HbA1c (in diabetic patients), serum creatinine, calculation of estimated glomerular filtration rate [11], alpha fetoprotein, pregnancy test for females in the child-bearing period, and pelvic-abdominal ultrasonography. Child Pough assessment of cirrhotic patients was done [12]. Patients had been treated with Sofosbouvir 400 mg, Daclatasvir 60 mg for 12 weeks. During the treatment period, 2019 group (routine classical group) of patients were followed up by regular routine classic visits every 2-4 weeks while 2020 group (telemedicine group) of patients were followed up by telemedicine and different communication methods as the patients received three doses of sofosbouvir  400 mg and daclatasvir 60 mg once and were instructed to send their follow up laboratory results and follow up symptoms checklist sheet via whatsApp application  to well defined certain mobile numbers and this is the preferred method or via certain e mail at the end of every dose. There is also a well-known hot line for emergent clinical problems and video communications if needed at specific preset dates, complete blood count, creatinine, bilirubin, AST, ALT were monitored, Quantitative PCR for HCV RNA at 12 weeks after the end of treatment was done.

The gathered data were inserted, and statistically analyzed using statistical package for social sciences program (SPSS) software version number 24. Qualitative data were expressed as proportions while quantitative data were expressed as mean + standard deviation (SD) and median plus inter quartile range (IQR). Statistical significance was defined when p values are less than 0.05.

RESULTS:

The present retrospective study included cross matched 300 patients were suffering of chronic HCV and were treated by direct acting antiviral regimen for 12 weeks, were divided into two equal groups; routine classical group of patients were followed up by regular routine classic visits every 2-4 weeks till the end of treatment and telemedicine group of patients were followed up by telemedicine and different modern communication methods. Table 1 shows the baseline characters of both groups; as regard age, sex, residence and the presence of comorbid diseases; baseline characteristics were generally balanced between the studied groups. Table 2 shows that there are no significant statistical changes between routine classical group of patients and telemedicine group of patients regarding the different laboratory measures. Table 3 shows that the treatment response in telemedicine group of patients is about (98.6%), two patients (1.4%) didn’t achieve SVR, the response to treatment in routine classical group of patients is about (99.3%) only one patient didn’t achieve SVR, no significant difference between both groups regarding response to treatment (P value ˃ 0.05), all patients in the studied groups completed the course of treatment. Table 4 shows that total number of patients experienced adverse effects in telemedicine group of patients is 17(11.3%) versus 13(8.6%) in routine classical group of patients as follow; headache occurred in 2 patients (1.3%) in telemedicine group of patients also in 2 patients (1.3%) in routine classical group of patients. fatigue occurred in 3 patients (2%) in telemedicine  patients  versus 2 patients (1.3%) in routine classical patients. lower GIT symptoms occurred in 2 patients in 2020 group  (1.3%) versus one patient (0.7%) in routine classical group. Upper GIT symptoms occurred in 2 patients (1.3%) in telemedicine group of patients versus 3 patients (1.3%) in routine classical group of patients. Itching occurred in 2 patients (1.3%) in telemedicine patients versus one patient (0.7%) in routine classical patients, chest symptoms occurred in one patient in telemedicine patients (0.7%) and also in one patient (0.7%) in routine classical patients, hemoglobin drop below 10g occurred in one patient (0.7%) in telemedicine group of patients also in one patient (0.7%) in routine classical group of patients, no record for affection of white blood cells, no record for fever or severe complications such as development of ascites, hepatic encephalopathy or upper and lower GIT hemorrhage in studied groups, no significant difference between telemedicine patients or routine classical patients regarding adverse effects (P value ˃ 0.05). Table 5 shows that in telemedicine HCV group of patients 135 patients (90%) are satisfied by the telemedicine way as a method of communication between the doctor and the patient while 15 ones aren’t satisfied (10%). In routine classical HCV group of patients 125 patients (83.3%) are satisfied by the classic way for follow up between patient and doctor in the form of regular routine visits while 25 ones (16.7%) aren’t satisfied no significant difference between both groups regarding patient satisfaction (P value >0.05). 

SD (standard deviation)

Table (2): Laboratory data before treatment.

-        Independnet samples T test for parametric quantitative data between the two groups

-        Mann Whitney test for non- parametric quantitative data between the two groups

*: Significant level at P value < 0.05, ALT (alanine transferase), AST(aspartate transferase), INR(international normalized ratio) , IQR(interquartile range), SD(standard deviation)

Table (3): Response and compliance on treatment.

*: Significant level at P value < 0.05   SVR (sustained virological response)

 Table (4): Adverse effects and morbidity.

-        Independnet samples T test for parametric quantitative data between the two groups

-        Chi square test (if less than 20% of cells have expected count <5) or Fisher exact test (if more than 20% of cells have expected count <5) for qualitative data between the two groups

     *: Significant level at P value < 0.05

DISCUSSION