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Adefovir dipivoxil (Geoffrey power) for long by srf asgas
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Adefovir dipivoxil (Geoffrey power) for long |
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Most patients with chronic hepatitis B with interferon or a certain course of treatment of nucleoside drugs often can not obtain a complete response, which requires long-term treatment. Therefore, long-term treatment antiviral efficacy, safety, and drug resistance has been developed for hepatitis B programs need to consider important issues. Study confirmed that adefovir dipivoxil (Geoffrey force) for the treatment of HBeAg-positive or HBeAg-negative chronic hepatitis B, lamivudine resistant HBV infection, HBV infection because of the need for liver transplant patients before and after surgery, or combined HIV infection chronic hepatitis B patients. The long-term treatment of adefovir dipivoxil clinical trials published in the near future, the following pairs of long-term adefovir dipivoxil treatment data were reviewed.
Long-term treatment efficacy of adefovir dipivoxil
End can be used to measure the number of treatment of chronic hepatitis B patients on the drug response. However, the main goal of treatment is to fully suppress viral replication, thereby reducing inflammation and necrosis of liver disease, prevention of cirrhosis, liver failure, the incidence of hepatocellular carcinoma. Therefore, adefovir core study 437 and 438, the primary endpoint was improvement of liver histology, while secondary endpoints included biochemical improvement (serum ALT normalization) and viral suppression (serum HBVDNA down), etc. .
Two core clinical studies have shown that in the primary endpoint improvement of liver histology, the effect of adefovir dipivoxil was significantly better than placebo (P <0.05), which is defined as histological improvement in Knodell inflammatory necrosis score increased by 2 points, and the Knodell fibrosis score did not decline. 438 study, 64% (79/123 cases) in patients 1 year after treatment, serum HBVDNA down to 1000copies/ml below 72% (84/116 cases) were ALT normalization. Long-term treatment of adefovir dipivoxil, the observed significant improvement in liver histology. Grade assessment, compared with liver biopsy before treatment, after 240 weeks of adefovir dipivoxil therapy, inflammation and necrosis and fibrosis in patients with improvement rates were 73% and 75%. Treatment of 5 years, 67% of patients decline to 1000copies/ml HBVDNA below 69% of the patients have been ALT normalization. Adefovir dipivoxil treatment of 1 to 5 years, changes in serum ALT HBVDNA and shown in Figure 1. Similarly, the 437 study, adefovir dipivoxil 67% 5-year improvement in patients with inflammatory necrotic lesions, 60% of patients have fibrosis improvement.
HBeAg seroconversion is also a researcher of concern. 437 study, were 14%, 33% and 46% of patients in the treatment of 1,2 and 3 years after the occurrence of HBeAg seroconversion. Seroconversion rates with adefovir dipivoxil treatment time gradually increased. 437 study also observed the occurrence of HBeAg conversion out of adefovir dipivoxil in patients with sustained response after the time. The results showed that 91% occurred in patients with HBeAg seroconversion after stopping at an average of 3 years of follow-up remained HBeAg seroconversion. The reversal occurred in patients with serum (anti-HBe disappeared, HBeAg reproduce) received adefovir dipivoxil for the average course of treatment shorter than those obtained in patients with sustained seroconversion.
Treatment of patients with lamivudine resistance
Adefovir dipivoxil in patients with YMDD mutation Literature Has a lot of them, in the 435 study, monitoring the two groups of liver transplantation with lamivudine-resistant patients receiving long-term efficacy of adefovir dipivoxil treatment. In an interview with orthotopic liver transplantation (OLT) before, 59% (45/76 cases) of patients receiving adefovir dipivoxil for a year after the HBVDNA <1000copies/ml, 77% were ALT normalization. 2 years after treatment, 65% (13/20 cases) in patients HBVDNA <1000copies/ml, 77% of patients with ALT normalization. In the post-OLT patients, treatment for 3 years data, HBVDNA down to 1000copies/ml number of patients under treatment with extended number of years increased, in the treatment of 1,2 and 3 years after the rates were 40% (64/159 cases), 65% (61/94 cases) and 78% (35/45 cases), and the incidence proportion of patients with ALT normalization were 51% (56/110 cases), 70% (46/66 cases) and 58 % (15/26 cases).
435 study is now in chronic hepatitis B patients with decompensated largest study conducted, at the beginning of treatment, a total of 60% and 25% of pre-OLT OLT in patients with the Child-PughTurcotte (CPT) classification in B or C grade. Before OLT in patients 1 year after treatment (32 cases), CPT score median improvement of 2 points, but after 2 years of treatment is still able to maintain CPT score improved (5 cases). After 1 year post-OLT patients (20 cases), 2 years (11 cases) and 3 years (7 cases) after treatment, CPT score median improvement of 3 points. Another study, 29 patients with LAM resistant CHB patients treated with adefovir 52 weeks. The results reveal that the disappearance of HBeAg, HBeAg seroconversion, and access to health risk of chemical and virological response were 23.5%, 11.8%, 82.8% and 48.2%.
Cases with HIV infection in 35 patients, 460i study A willing N? blast assessment? Chase beetle? Ostrich cheek knock some Suwa Bodhisattva ? Like Lan Di Xin; cheek blast Jia Hui Lei bear in mind the profile control of barium? BVDNA levels were higher (median level 9.8log10copies/ml). 4 years after treatment, 58% of the patients have been HBVDNA <1000copies/ml, 70% were ALT normalization. The merger of HIV infection in HBV patients during treatment also has been improved liver histology, treatment of 1 year and 4 years were 33% and 50% of patients have improvement of liver fibrosis.
Adefovir dipivoxil therapy in patients with lamivudine resistance has become the main drug.
Adefovir dipivoxil safety of long-term treatment
Of adefovir dipivoxil in the course of HIV infection found that high doses of medication and the reversibility of renal toxicity. in any clinical studies, adefovir dipivoxil 10mg / d after 1 year of treatment and found no significant drug-related increase in serum creatinine and serum phosphorus decreased. In the continued use of 10mg / d treatment after 5 years of HBeAg-negative patients (438 studies), no serum phosphorus level in 1 case <2.0mg/dl, 3% (4 / 125 cases) of cases were found in serum creatinine value of more increased baseline level 0.5mg/dl.
Application in transplantation patients the safety of adefovir dipivoxil has also been a good evaluation. Specifically, these patients are also taking drugs with renal toxicity (eg, cyclophosphamide, tacrolimus), and often already have kidney damage. Because adefovir clearance through the kidneys, so adjust according to renal function in patients with dose is very important. The results showed that these patients regardless of pre-existing kidney damage how, in the treatment of 1 year and 3 years I am an expert from Mp3 Player Manufacturers, usually analyzes all kind of industries situation, such as eating silica gel , how to use clenbuterol.
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