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Impact of duration of therapy on side effect profile of anti-HCV protocol: A retrospective cohort study from two tertiary health facilities in Pakistan
Abstract
Purpose: To evaluate the plausible risks and adverse effects related to the duration of therapy in hepatitis C (HCV) patients in Lahore, Pakistan.
Method: A retrospective observational study involving 250 HCV patients who received combination therapy with ribavirin and interferon was conducted. The patients were segregated into two groups on the basis of duration of therapy (≤ 6 months and > 6 months). Adverse effect profiles of patients under treatment were collected using a pre-validated questionnaire and compared using Pearson’s Chi- Square Test/Chi-Square Goodness-of-Fit tests and unpaired t-test.
Results: Patients who underwent treatment for ≤ 6 months frequently encountered side-effects such as GIT disturbance (23.77 %) and joint pains (29.63 %). Additionally, diabetes mellitus (27.86 %) and frequent injections (74.59 %) were the most commonly observed co-morbid condition and disease risk, respectively. On the other hand, in patients who underwent therapy for > 6 months, skin disorders (30.46 %) and gastric acidity (10.15 %) were the most frequently observed side-effects with less frequent reporting on co-morbid conditions and disease risk factors. Moreover, there was a significant reduction in body weight (p = 0.03), serum bilirubin (p = 0.0005), albumin (p = 0.003) and triglycerides (p = 0.006) levels due to longer duration of treatment.
Conclusion: The data suggest that treatment-related risks are higher among HCV patients on shorter treatment duration whereas adverse events subside in patients on longer duration of therapy (>6 months). Changes in biochemical profile were also more evident in those receiving treatment for periods >6 months.
Keywords: Interferon, Ribavirin, Side effects, Duration of therapy, Outcomes of therapy