Tenofovir clinical evaluation
Applied to HIV infection
In a study of 186 HIV-1-infected patients, patients received one of three doses (75, 150, or 300 mg) of placebo or their own, in combination with other antiretroviral drugs, 48 weeks. At 24 weeks, the mean time-weighted mean of plasma HIV-1 RNA levels was 0.02% more than the baseline and 0.58 for the placebo group. And the reaction continued, to 48 weeks, the changes in the baseline value of this product group to reduce 0.62.
In another 550-patient study, patients had a mean baseline plasma HIV-1 RNA level of 3.4 copies / mL and a mean basal CD4 cell count of 427 / mL. Study patients received placebo or the goods 245 mg, medication for 24 weeks. At 24 weeks, 0.03 copies / ml and 0.61 copies / ml decreased in the placebo group and the product-treated group, respectively. The mean time-weighted mean CD4 cell count also varied significantly from baseline, with a 13-milliliter increase in the product group and a 11-milliliter decrease in the placebo group. In addition, at 24 weeks, 45% of the patients in this product group had a viral load below the detectable threshold, compared to 13% in the placebo group.
These studies also show that most strains that are less susceptible to nucleoside reverse transcriptase inhibitors respond to tenofovir. Fewer susceptibility to tenofovir decreases or the sensitivity to nucleoside reverse transcriptase inhibitors crosses less.
Applied to HBV infection
German scientist van Bommel et al reported at the 58th Annual Liver Diseases Annual Meeting of AASLD in 2007 on the 10 chronic cases of resistance to adefovir (ADV) after resistance to lamivudine (LAM) Hepatitis B patients underwent tenofovir (TDF) monotherapy over 12 months; HBV polymerase gene cloning was performed prior to and during treatment. The results showed that HBV-DNA decreased by 4.4 (2.8-5.5) log10copies / ml at 12 months and that HBV-DNA with an average of 3.3 (1.5-4.9) log10copies / ml was still detectable in 8 of 10 cases. During follow-up, 5 patients had HBV-DNA <400 copies / ml. No virological breakthrough occurred throughout the course of treatment. The results show that TDF monotherapy has a significant antiviral effect on HBV-DNA in ADV-associated and combined variants at different drug resistance sites.
In general, this product is easy to tolerate. And nucleoside reverse transcriptase inhibitors, this product does not exist myelosuppression, peripheral neuropathy or pancreatitis.