Effectiveness and Tolerance of Tenofovir Disoproxil Fumarate in Sub-Saharan Viral B Cirrhotic Patients

Tenofovir reduces viral load during viral cirrhosis B and improves prognosis. The aim of this study was to evaluate the effectiveness and safety of Tenofovir during the treatment of viral B cirrhosis. The study was retrospective and prospective on patients with viral B cirrhosis treated with Tenofovir in the Hepato-Gastroenterology Department of University Hospital Gabriel Touré in Bamako (Mali) and evaluated between three and six months after the start of treatment. We included 89 patients. The mean age was 44.5 ± 16 years with extremes of 18 and 90 years. The sex ratio was 1.2. At inclusion all patients had a detectable viral load with an average of 2651.96 ± 1495.85 IU/ml. Follow-up viral load was undetectable in 84.3% with patients between 3 and 6 months of treatment. The average detectable viral load was only 27.04 ± 21.05 IU/ml. There was also an improvement in hepatocellular function and few side effects. Conclusion: This study shows the interest of Tenofovir in the treatment of viral cirrhosis B with very few adverse effects.

Current treatments by nucleic analogue and interferon can stop virus replication and thus stabilization or even improvement of hepatic disease [9].Tenofovir Disoproxil Fumarate (TDF) effectiveness has been proven with the advantage of having a high genetic barrier against the virus [9] [10].However, the major risk of this drug is its renal toxicity and bone defect [11].
In Mali, the prevalence of HBs antigen in the general population ranges from 13.9% to 15.5% [12] [13] and this viral marker was found in 55% to 71% of cirrhosis and in 55% to 62.2% of hepatocellular carcinoma [3] [14] [15].TDF is more and more accessible in the treatment of HBV infection.The risk of this treatment has not been evaluated in our context.We initiated this study with the aim to evaluate the efficiency and safety of TDF in viral B cirrhotic patients.

Patients and Methods
The study was retrospective from April 2014 to April 2015 and prospective from May 2015 to October 2016 and took place in the service of Hepato-gastroenterology of CHU Gabriel Touré in Bamako, Mali.
The study included HBV cirrhosis patients treated with TDF.The patients had HBV viral load assay at the start and between 3 and 6 months of the treatment.
For the retrospective period the data were collected from the service records.
During the prospective period the data were recorded in real time.The study parameters collected were gender, age, causes of consultation, clinical examination data, HBV viral load, adverse effects of TDF, the course of the disease.
All the patients were informed about the course of the study and gave their approval.
Data analysis was done on Epi Info statistical software version 6.04.The chi 2   statistical test was used to analyze our results with a significance level for P < 0.05.

Results
At the end of the study, 89 patients were collected.The sex ratio was 1.2 (66 men versus 23 women).The average age of the patients was 44.5 ± 16 years with extremes of 18 and 90 years.The 25 -34 age group was more represented.Ascites and jaundice were the main causes of consultation (Table 1).At inclusion, ascites and hepatomegaly were the most observed clinical signs (Table 2).The HBV viral load, detectable in the all patients, was greater than 2000 IU/ml in 49.4% of patients with an average of 2651.96 ± 1495.85IU/ml.In 65.2% of cases the patients had decompensated cirrhosis.The TDF treatment improved significantly hepatocellular function (Table 3).After three months of treatment the viral load became undetectable in 84.3% of patients and the average detectable viral load was only 27.04 ± 21.05 IU/ml.Nephropathy was observed in 8 patients (Table 4).The global mortality was 7.9% (7 patients including 3 with nephropathy).Open Journal of Gastroenterology

Table 1 .
Causes of consultation.

Table 4 .
Adverse effects of treatement.