A Case Report on Comorbidities and Laboratory Abnormalities of Lamivudine in Hepatitis B Patients

About Authors:Dhaval Patel*^[1], Pratham Rathore^[1], Prerna Sharma^[1], Dr. Pankaj Shah^[2]
1 Department of Pharmacy Practice,
School of Pharmaceutical Sciences,
Jaipur National University,
Jaipur -302025, (Rajasthan), India
2 Institute of kidney disease and research center,
civil hospital, Ahmedabad, (Gujarat), India

Abstract
Inpresent study, comorbidities and laboratory abnormalities of lamivudine was analysed in hepatitis b patients. Clinical data were collected from hepatitis b patients that presented with laboratory abnormalities to lamivudine. We examined 100 patients of hepatitis b who treated with lamivudine in i.k.d.r.c, civil hospital, Ahmedabad from January 2009 to February 2011. The main laboratory abnormalities were elevation of creatine kinase, elevation of AST, elevation of serum lipase. Hypertension was the major comorbidities with the hepatitis b. The laboratory abnormalities were related to lamivudine, but the biological mechanism of the reaction is not clear.

Reference ID: PHARMATUTOR-ART-1126

Introduction
Hepatitis is a general term meaning inflammation of the liver and can be caused by a variety of different viruses such as hepatitis A, B, C, D and E. Hepatitis B is a serious and common infectious disease of the liver. Hepatitis B virus (HBV) infection is a significant health problem worldwide. The hepatitis B virus is a DNA virus, meaning that its genetic material is made up of deoxyribonucleic acids. It belongs to a family of viruses known as Hepadnaviridae. The virus is primarily found in the liver but is also present in the blood and certain body fluids. ^[1]

Of the 6 billion worldwide populations, an estimated 2 billion have been infected by HBV. ^[2] It is estimated that 350-400 million people have chronic hepatitis B (CHB) infection. ^[3] There is clear epidemiologic evidence that chronic HBV infection can result in the development of hepatocellular carcinoma (HCC) and cirrhosis. ^{[4, 5]} Approximately 15%-40% of HBV carriers develop cirrhosis, liver failure, and HCC; worldwide, more than 50% of primary HCC is related to chronic HBV infection. ^[6] Each year, 500 000 deaths are expected because of complications related to hepatitis B. ^[7]

In India nearly 3%-4% of the population is infected by the virus, and chronic hepatitis B constitutes more than 50% of the chronic hepatitis cases in the country. ^[8] The prevalence ranges from 1.1% to 12.2% with maximum incidence in Madhya Pradesh, Gujarat, Arunachal Pradesh and South India and least in Kashmir and Kerala. ^[9] There is peak prevalence after the second decade of life. Most (90%) of these HBV infected subjects are HBeAg negative; the majority (80%) have normal ALT. ^[10] The prevalence of HBeAg among asymptomatic HBsAg positive persons varies from 9%-20%. ^[11]

Lamivudine is a nucleoside analogue antiviral drug with activity against HIV-1 and HBV. Lamivudine is phosphorylated to its active 5'-triphosphate metabolite, lamivudine triphosphate in the body which inhibit the reverse transcriptase (RT) enzyme via DNA chain termination.It works by lowering viral load (HBV DNA) by preventingthe virus’s replication process. It has been a new option for the treatment of chronic hepatitis B after interferon therapy, because it significantly suppresses hepatitis B virus (HBV) replication. ^{[12, 13]}

Materials and Methods
Subjects
In present study we examined 100 patients who were treated with lamivudine for hepatitis B at an inpatients and outpatient department of i.k.d.r.c, civil hospital, Ahmedabad, from January 2009 to February 2011.

Methods
A retrospective method was employed to analyze the medical records of the all patients, including: general information, medicine history, lamivudine treatment, dosage, combined medication, time of occurrence of laboratory abnormalities as well as results of laboratory tests, such as routine blood analysis, liver function, and kidney function.

Results and Discussion
In present study a randomized observation study on 100 patients of hepatitis b was conducted who were treated with the lamivudine and examined for laboratory abnormalities. These patients were selected with the inclusion criteria only. All the patients successfully completed the lamivudine therapy. There were no cases of the discontinuation of the therapy.

We studied the comorbidities with the hepatitis b patients which are shown in table 1. It was observed that hypertension (33%) and diabetes mellitus (11%) was the major comorbidities in the patients. Other comorbidities like amenorrhea (1%), myocardial infarction (4%), cirrhosis (2%), tuberculosis (6%), cancer (2%) and urinary tract infection (5%) are also present in few patients.

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Table 1: Comorbidities with the hepatitis b infection

Comorbidities with the hepatitis b

Total no. of patients

Hypertension

Diabetes mellitus

Tuberculosis

Urinary tract infection

Amenorrhea

Cirrhosis

Congestive cardiac failure

Myocardial infraction

Cancer

During the study we observed laboratory abnormalities of the lamivudine therapy. Creatine kinase (CK) elevation was the most frequent side effect of lamivudine therapy. Lamivudine produced CK elevation in 7% patients within the four to five months of lamivudine therapy.

Lamivudine also produced elevation of serum glutamic oxaloacetic transaminase (SGOT) (4%), elevation of serum glutamic pyruvic transaminase (SGPT) (4%), elevation of serum lipase (2%), elevation of serum amylase (1%) and elevation of neutropenia were also associated with lamivudine therapy.

Table 2: laboratory abnormalities of the lamivudine treatment

No.

Adverse events

Lamivudine therapy

Approx time of laboratory abnormalities after the initiation of lamivudine therapy

No. of patients (%)

01 Creatine kinase (CK) > 4.0 x ULN 07 (7.0) four-five months

02 ALT (SGPT) > 5.0 x ULN 04 (4.0) four-five months

03 AST (SGOT) > 4.0 x ULN 04 (04) three month

04 Serum lipase > 3.0 x ULN 02 (2.0) five-six months

05 Neutropenia 02 (2.0) three-four months

06 Serum amylase >2.5 x ULN 01 (1.0) two-three month

Conclusion
In present study, comorbidities and laboratory abnormalities of lamivudine was studied in i.k.d.r.c, civil hospital, Ahmedabad. Author observed that hypertension and diabetes mellitus was major comorbidities with the hepatitis b. The most common laboratory abnormalities of lamivudine were creatine kinase elevation, elevation of neutropenia, elevation of AST and elevation of ALT.

Acknowledgement
Author sincerely thanks to Director, Staff and Co-staff of the IKDRC for the providing all facilities and moral support for these work.

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