Treatment profile of hepatitis C patients - a comparison of interferon alpha 2a and 2b treatment regimes.

OBJECTIVE: To compare the side effects, cost, end treatment response (ETR) and Sustained viral response (SVR) with combination therapy of either interferon alpha 2a or 2b in combination with Ribavarin. STUDY DESIGN: Randomized Control Clinical Trial (RCCT). PLACE AND DURATION OF STUDY: The study was conducted at Sarwar Zuberi Liver Centre (SZLC), Civil Hospital Karachi (CHK), from May 2004 to July 2009. METHODOLOGY: Patients positive for qualitative HCV ribonucleic acid (RNA) by Polymerase chain reaction (PCR) and genotype 3 were included. Patients with decompensated cirrhosis, severe depressive illness, autoimmune hepatitis, hyperthyroidism, pregnancy, heart failure, uncontrolled diabetes, obstructive pulmonary disease, children less than three years and patients who had previously received treatment were excluded. Single blind randomization using computerized randomization list was done and patients divided into groups A and B, those requiring treatment were given injection Interferon 3 million units (MU) subcutaneously (SC) three times/week and Ribavarin 1000 mg per day (weight ≤ 75kg) and 1200 mg/day (weight > 75kg) orally with either interferon alpha 2a (group A; FDA approved products) or alpha 2b (group B; non FDA approved product). Demographics, side effects, ETR and SVR were noted. ETR was defined as absence of virus at the end of treatment and SVR was taken as absence of HCV RNA at 6 months after completion of treatment. RESULTS: There were a total 310 patients with mean age of 34.07 +/- 9.38 years including 52.4% males, (n=162). Majority of the patients were from North Pakistan. There were 155 patients each in group A and group B respectively. The cost of treatment for interferon alpha for a single patient for 6 months was Rs 60,000, while for Interferon alpha 2b was Rs 30,000. Side effects (fever initially, followed by fatigue, headache, musculoskeletal pain, depression, alopecia, insomnia, and anorexia) were more prominent in group B when compared with group A. In group A, ETR was 83.8% (130/155) while in group B was 83.2% (129/155). While SVR available in group A was 61/70 (87.1%) and in group B was 60/72 (83.3%). CONCLUSION: Response to combination therapy for HCV was 83%. ETR and SVR were similar for both interferon alpha 2a and 2b. Side effects though minor are more with alpha 2b (non FDA approved products).

Frequency of rectal varices in patients with cirrhosis.

OBJECTIVE: To document the frequency of rectal varices in patients with cirrhosis of liver and compare it with that of oesophageal varices in liver and to compare the frequency of rectal varices with non-cirrhotic controls. DESIGN: A cross-sectional analytical survey. PLACE AND DURATION OF STUDY: The study was conducted in the medical wards of Civil Hospital, Karachi from August 2000 to July 2001. PATIENTS AND METHODS: All patients of confirmed cirrhosis of liver, presenting during the study period, were selected for initial workup. On the basis of upper gastrointestinal (GI) endoscopy, patients were segregated into those with oesophageal varices (Group-A) and those without them (Group-B). A matched control group (Group-C) was added, which consisted of patients of irritable bowel syndrome (IBS) who underwent sigmoidoscopic/colonoscopic examination during the study period. Fiberoptic sigmoidoscopy was done in all selected patients. Statistical analysis for continuous variables was done by student's 't' test while non-continuous variables were analyzed by Mann-Whitney-U test. RESULTS: A total of 104 patients (males 61; females 43) were included. Hepatic encephalopathy grade was significantly lower in Group-B (p < 0.0001). Grade-I varices were seen in 13 patients, Grade-II in 38 and Grade-III in 33 patients of Group-A. Rectal varices were present in 59.9% of patients in Group-A as compared to Group-B in which no one had them (p <0.0001). CONCLUSION: Rectal varices are common in patients of portal hypertention.

Pharmacokinetic differences of some generic tablet gliclazide 80 mg on Pakistani population.

The goal of rational drug therapy is to produce a desired pharmacological response in an acceptable and predictable manner while minimizing the occurrence of undesired events. The Pharmacokinetics of different generics of tablet gliclazide 80 mg was investigated on healthy (10 x 2), Pakistani subjects. For this exploration an open-label, randomized, two-period crossover (Balanced in Complete Block Design) study, was conducted The out come of the said study suggests that all generics were found analogous regarding pharmacokinetic behavior in-spite of having different excipients, concentration of excipients, sources of raw material, manufacturing process, machinery, resources and also inter individual variation of the study. Results of the study also undoubtedly advocate that generics manufactured in different manufacturing units of Pakistan are near to the standard formulation and produce comparable results. No significant differences in pharmacokinetics parameters were observed, however, minor differences might narrate with inter individual variation in human volunteers and in different generic as well as different pharmaceutical unit.