HIV Prevalence among HCV Egyptian Infected Patients and Its Impact on the Result of HCV Treatment ()
1. Introduction
The incidence of hepatitis C virus (HCV) is 20% in highly endemic areas, including urban centers and the Nile Delta in Egypt [1]. Egypt has the largest epidemic of hepatitis C in the world. The percentage of Egyptians with HCV is 14.7%. This is ten times greater than any other country in the world. Nearly half live in urban areas. The prevalence of HCV varies throughout the country. The northern Nile Delta appears to have the highest prevalence, ~28%. The much smaller population of Upper Egypt, in the south, seems to have the lowest HCV prevalence, ~16% [2]. Among the six major HCV genotypes found worldwide, genotype 4 is the most predominant in Egypt, with 4a as the dominant subtype [3].
The HIV epidemic has claimed the lives of nearly 30 million persons worldwide, and an estimated 34 million persons currently are living with HIV infection in 2011 [4].
The prevalence of HIV in Egypt is 0.03 among the general population and ranges from 0.05 - 0.5 among people with high risk behavior (in 2009, number of people living with HIV/AIDS was 11,000 (2400 women, <0.1% adults) and number of deaths were <500), so Egypt faces several challenges in maintaining a low prevalence of HIV/AIDS [5].
Infection with HCV is the most common co-infection in people with HIV since both infections share similar routes of transmission [6]. So all HIV-infected persons should be evaluated for chronic HCV infection using a third generation enzyme immunoassay. Patients who are found to be HCV seropositive should undergo quantitative HCV RNA testing in order to confirm the presence of viremia. Patients who are found to be HCV seronegative should undergo HCV RNA testing if they have advanced immune suppression (e.g., CD4 counts < 100 cells/mm3), risk factors for HCV infection, or elevated aminotransferases [7].
We aimed to determine the prevalence of HIV infection in chronic HCV patients and to detect the impact of HCV/HIV co infection on the response to treatment with Peg interferon and Ribavirin in chronic HCV patients.
2. Patients and Methods
2.1. Study Population
This is a retrospective study which was performed on one thousand eight hundreds and fifty two patients; all of them were attending The Tropical Medicine Department, Outpatient Clinic of Kasr El Aini Cairo University and Kasr El Aini Viral Hepatitis Center & EL Fatemeia hospital during the period from May 2009 to October 2011: all of them were HCV positive patients and they were attending to receive the anti viral therapy in the form of interferon either alpha 2a, alpha 2b or standard interferon and Ribavirin, their sera were examined for HIV by ELISA test and confirmed by ELISA twice to detect the prevalence of HIV among HCV patients and also to detect how co infection HCV/HIV affect their response to interferon and ribavirin therapy.
2.2. Study Design
Upon HIV testing for all patients, two groups were generated:
Group 1:
Included 1840 HCV patients’ with positive anti-HCV antibodies tested by third generation ELISA and positive HCV RNA by PCR; they were 408 (22.2%) females and 1432 (77.8%) males.
Group 2:
Included 12 HIV positive patients detected by ELISA test and confirmed by ELISA twice and positive antiHCV antibodies tested by third generation ELISA and positive HCV RNA by PCR, they were 10 (83.3%) males and 2 (16.7%) females.
• Inclusion criteria:
• Adult HCV + ve patients of both sexes.
• METAVIR score: A2 and ≥F1 or ≥A1 and ≥F2;
• ALT > 1.5 UNL.
• No prior treatment with any type of IFN and ribavirin.
• Hemoglobin over or equal 11 g/dl, Leucocytes over or equal 3000/mm3, Neutrophils over or equal 1500/ mm3, Platelets over or equal 100,000/mm3, Blood creatinine equal or less than 1.5 mg/dl, Normal TSH, Fasting blood sugar between 70 - 115 mg/dl (if glucose intolerance or diabetes: HbA1C ≤ 8.5%).
• Normal ophthalmologic examination in patients with history of hypertension and/or diabetes.
• Effective contraception during the treatment period for both sexes.
• No breastfeeding during the treatment period.
• Exclusion criteria:
• Patients with autoimmune hepatitis.
• Patients with concomitant HBV.
• Patients with drug history, which can elevate liver enzymes.
• Patients with alcoholic hepatitis.
• Pregnant female or any patient planning for pregnancy.
An informed consent was obtained from all patients.
2.3. Methods
All patients of both groups (I & II) were subjected to the following:
Careful history taking and thorough clinical evaluation with special emphasis on the evidence of liver dysfunction and physical conditions that could be contraindications to treatment.
Laboratory investigations: Including urine and stool analysis, CBC, ESR, liver profile: in the form of (ALT, AST, total and direct bilirubin, serum albumin, PC &INR in addition to AFP). Autoimmune profile (ANA & ASMA), TSH level, T3 and T4, Anti Schistosomal Abs; Hepatitis markers HCVAb, HBsAg & HBcAb detected by ELISA; HCV RNA by PCR.
As well as detection of HIV antibody by ELIZA test and confirmed by ELISA twice.
Abdominal ultrasound: For assessment of the liver, spleen, portal vein, presence of ascites.
US guided liver biopsy: Liver biopsies played a central role in the evaluation of chronic HCV patients. Our biopsies were scored according to METAVIR Score [8]. Fibroscan by echo sense was made for some patients.
2.4. Statistical Methodology
Quantitative data were presented by mean and standard deviation (SD). They were compared by student s t-test. Non parametric data were presented by Median and Interquartile range (IQR). They were compared by Mannwhitney U test.
Qualitative data were presented by number and percent. They were compared by Chi-square test or Fischer s exact test when appropriate. In all test, P value was considered significant if less than 0.05.
3. Results
The prevalence of HIV among HCV infected Egyptian patients was 12/1852 (0.66%). The demographic features of the studied groups regarding their age, sex and BMI showed G-I which included 1840 patients, 1432 (77.8%) males and 408 (22.2%) females, their mean age was 40.94 ± 10.182 years and their mean BMI was 28.054 ± 4.3141 and G-II which included 12 patients, 10 (83.3%) males and 2 (16.7%) females, their mean age were 41.89 ± 10.142 years and their mean BMI was 27.349 ± 2.9316. There was no statistical significant difference between the two groups regarding their gender, age and BMI. By revising the risk factors for specific HIV infection we found risky occupation (tourism), travelling abroad in 2 patients out of the 12 HIV patients. The biochemical parameters between the two studied groups regarding serum albumin, AST, ALT, ALP showed no statistical significant difference as P > 0.05 as shown in Table 1.
There was no statistical significance between the studied groups regarding the baseline hematological parameters, clinical or ultrasonographic findings as all were scheduled for anti-viral therapy.
The difference between the two studied groups regarding the quantitative PCR for HCV is shown in Table 2. HCV RNA was much higher in group I (HCV only) (though insignificant) as p = 0.8.
The grades of inflammation of the liver tissue between the two studied groups were illustrated in Table 3, 335 patients were with no available data (18.2%) (There were 328 patients with either missing data or they did not do it for administrative or medical reasons and 7 patients did fibroscan), There was no statistical difference between the two studied groups as regard grades of inflammation or stage of fibrosis.
The type of treatment of the studied groups is shown in Table 4.
Group I: 884 patients (48%) were on interferon alpha 2a, 842 patients (45.8%) were on interferon alpha 2b, 60 patients (3.3%) were on no treatment, 54 patients (2.9%) were on standard interferon.
Group II: 8 patients (66.7%) were on interferon alpha 2a, and 4 (33.3%) were on interferon alpha 2b.
So most of the patients of the two groups were on pegylated interferon.
Outcome of treatment:
Failure: Patients who did not achieve a 2 log10 drop in HCV RNA by week 12 of treatment [9].
Relapse: Patients who had an undetectable viral load at the end of a prior attempt at treatment (end of treatment response) but who did not achieve a sustained virologic response (negative HCV RNA 24 weeks after completing treatment) [9].
Sustained virological response (SVR): absence of HCV RNA by polymerase chain reaction six months after stopping treatment [10].
Our patients response to treatment of the two groups was, 1050 patients (56.7%) were dropped out or did not receive treatment, 372 patients (20.1%) showed failure to treatment, 180 patients (9.7%) were under treatment, 39 patients (2.1%) were relapsed after end of treatment, and only 211 patients (11.4%) who reached the sustained virological response.
Table 5 showed the response to treatment of the two