Effect of chloroquine on some clinical and biochemical parameters in non-response chronic hepatitis C virus infection patients: pilot clinical trial.

BACKGROUND: Hepatitis C virus infection frequently leads to chronic hepatitis C which may progress to cirrhosis and can be ended to hepatocellular carcinoma. This study aimed to investigate the effect of Anthropometric Parameters, Vit D3, Thyroid Function, Ferritin and Biochemistry Parameters in patients chronically infected with HCV with non-response criteria which was treated by chloroquine. METHODS: This study was the continuation of our previous investigation with a triple-blind method in a randomized controlled pilot study. After understanding the study procedures, patients signed an informed consent form and were randomized into the treatment (chloroquine 150 mg once daily, for 8 weeks) and control (placebo once daily, for 8 weeks) groups. The inclusion criteria were male, between 18 and 60 years of age, confirmed chronic hepatitis C with non-response criteria, and Genotype 1.  Data were analyzed with an intention to treat perspective at the end follow up (12 weeks) considering to variables such as anthropometric parameters, Vit D3, thyroid function, ferritin and biochemistry parameters evaluated. RESULTS: Although there were decreases in total weight (P-value=0.4), mid-arm circumference (P-value=0.05), and body mass index (P-value=0.04) there were increases in total body fat (P-value=0.8) and triceps skin fold thickness  (P-value=0.7) in the intervention group compared to the control group. Also, a reduction of AST (P-value=0.30), ALT (P-value=0.10), cholesterol (P-value=0.005), triglyceride (P-value=0.40) and ferritin (P-value=0.030) levels was seen in the intervention group during the follow up period. Our results also showed that serum TSH levels (P-value=0.5) were slightly higher in the chloroquine group than in the placebo group, though the trend was reversed for T3 (P-value=0.05) and T4 (P-value=0.04) levels. however, median of T3 and T4 were similar in both groups. A significant increase in vitamin D levels from 15 to 34 ng/ml was observed in the chloroquine group (P-value=0.04). CONCLUSIONS: The results suggest that chloroquine therapy may be very useful for HCV treatment in patients with non-response criteria, and helps to normalize some anthropometric parameters, biochemical, ferritin, and vitamin D status.

New use of an old drug: chloroquine reduces viral and ALT levels in HCV non-responders (a randomized, triple-blind, placebo-controlled pilot trial).

Hepatitis C virus (HCV) infection induces autophagy, but the virus assimilates the autophagic response into its own life cycle. Chloroquine (CQ) is an autophagy inhibitor that is clinically used to treat malaria. The aims of this pilot clinical trial were to evaluate the therapeutic potential and short-term safety of CQ in patients with chronic HCV genotype 1, who were unresponsive to a combination of pegylated interferon alpha and ribavirin. Ten non-responders to previous antiviral treatment(s) were randomized to receive either CQ (150 mg daily for 8 weeks) or placebo, and were followed for 4 weeks after CQ therapy. HCV RNA load and plasma alanine transaminase (ALT) levels were measured at baseline, week 4 (initial response), week 8 (end-of-treatment response), and at the end of 12 weeks. A significant decrease in HCV RNA after the treatments (week 8) was observed in all patients in the CQ group (P = 0.04). However, HCV RNA levels increased within 4 weeks after discontinuation of CQ treatment although they were still lower than baseline. In addition, the ALT normalized during treatment in the CQ group. However, this response was also lost after treatment cessation. This study provides preliminary evidence that CQ is possibly a safe treatment option for HCV non-responders.

Effects of a subdermal levonorgestrel contraceptive implant (Norplant) on serum cholesterol, triglycerides, ALT and AST in Iranian women.

BACKGROUND: To evaluate the effects of Norplant (36 mg of levonorgestrel, six capsules) on serum cholesterol, triglycerides, alanine transaminase (ALT) and aspartate transminase (AST), we enrolled 465 healthy women from Zahedan, Iran, into a longitudinal study. MATERIALS AND METHODS: Blood samples were collected after an overnight fast before implant insertion and after 3, 6, 9 and 12 months of use. RESULTS: Total cholesterol and triglyceride levels did not significantly change during Norplant use. Although there were statistically significant increases in ALT and AST levels during Norplant use, the values were within the reference range.