Background:Albuvirtide is a once-weekly injectable human immunodeficiency virus(HIV)-1 fusion inhibitor.We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-riton...Background:Albuvirtide is a once-weekly injectable human immunodeficiency virus(HIV)-1 fusion inhibitor.We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs.Methods:We carried out a 48-week,randomized,controlled,open-label non-inferiority trial at 12 sites in China.Adults on the World Health Organization(WHO)-recommended first-line treatment for>6 months with a plasma viral load>1000 copies/mL were enrolled and randomly assigned(1:1)to receive albuvirtide(once weekly)plus ritonavir-boosted lopinavir(ABT group)or the WHO-recommended second-line treatment(NRTI group).The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks.Non-inferiority was prespecified with a margin of 12%.Results:At the time of analysis,week 24 data were available for 83 and 92 patients,and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups,respectively.At 48 weeks,80.4%of patients in the ABT group and 66.0%of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL,meeting the criteria for non-inferiority.For the per-protocol population,the superiority of albuvirtide over NRTI was demonstrated.The frequency of grade 3 to 4 adverse events was similar in the two groups;the most common adverse events were diarrhea,upper respiratory tract infections,and grade 3 to 4 increases in triglyceride concentration.Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group.Conclusions:The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug.This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure.Trial registration:ClinicalTrials.gov Identifier:NCT02369965;https://www.clinicaltrials.gov.Chinese Clinical Trial Registry No.ChiCTR-TRC-14004276;http://www.chictr.org.cn/enindex.aspx.展开更多
Chlamydia trachomatis (Ct) genital infection is the most common sexually transmitted disease (STD) in China and the US. The morbidity of Ct genital infection in China has increased from 32.48/100,000 in 2008 to 37...Chlamydia trachomatis (Ct) genital infection is the most common sexually transmitted disease (STD) in China and the US. The morbidity of Ct genital infection in China has increased from 32.48/100,000 in 2008 to 37.18/100,000 in 2015.[1] The major areas of Ct infections are concentrated in the Zhujiang Delta, Changjiang Delta, Minjiang Area, and West China. In these areas, the highest incidence of Ct infection reaches 615.99/100,000 citizens. In the US, there are 1,441,789 reported Ct, which include 627.2 females and 278.4 males per 100,000 population. It is now the most prevalent STD, with its rate increasing to 22% in males and 6% in females.[2] Ct genital infection can cause epididymitis, prostatitis, cervicitis, annexitis, infertility, and atopic pregnancy, which have been identified as the major public health problems.展开更多
Introduction Shiitake dermatitis (SD) is correlated with the ingestion of raw or undercooked shiitake mushrooms (SMs) and is more common in countries where SMs are habitually eaten.The condition was first reported in ...Introduction Shiitake dermatitis (SD) is correlated with the ingestion of raw or undercooked shiitake mushrooms (SMs) and is more common in countries where SMs are habitually eaten.The condition was first reported in Japan by Nakamura in 1977[1] and has since been recorded worldwide.The associated reports are rare in the domestic.This disease is characterized by intensely pruritic isolated or grouped papules or papulovesicles with whiplash-striped,infiltrated erythema that arise in a pattern consistent with the K(o)bner phenomenon because of stripe-like scratching,thus differing the lesions from the immediate onset of dermographism[1].展开更多
基金Frontier Biotechnologies Inc.,Ministry of Science and Technology of China(Nos.2013ZX09101001 and 2017ZX09201007)the Beijing Municipal of Science and Technology Major Project(Nos.D141100000314005,D141100000314002,and D161100000416003)+1 种基金the National Natural Science Foundation of China(Nos.81772165,81974303,and 81571973)Beijing Key Laboratory for HIV/AIDS Research(No.BZ0089)。
文摘Background:Albuvirtide is a once-weekly injectable human immunodeficiency virus(HIV)-1 fusion inhibitor.We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs.Methods:We carried out a 48-week,randomized,controlled,open-label non-inferiority trial at 12 sites in China.Adults on the World Health Organization(WHO)-recommended first-line treatment for>6 months with a plasma viral load>1000 copies/mL were enrolled and randomly assigned(1:1)to receive albuvirtide(once weekly)plus ritonavir-boosted lopinavir(ABT group)or the WHO-recommended second-line treatment(NRTI group).The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks.Non-inferiority was prespecified with a margin of 12%.Results:At the time of analysis,week 24 data were available for 83 and 92 patients,and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups,respectively.At 48 weeks,80.4%of patients in the ABT group and 66.0%of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL,meeting the criteria for non-inferiority.For the per-protocol population,the superiority of albuvirtide over NRTI was demonstrated.The frequency of grade 3 to 4 adverse events was similar in the two groups;the most common adverse events were diarrhea,upper respiratory tract infections,and grade 3 to 4 increases in triglyceride concentration.Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group.Conclusions:The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug.This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure.Trial registration:ClinicalTrials.gov Identifier:NCT02369965;https://www.clinicaltrials.gov.Chinese Clinical Trial Registry No.ChiCTR-TRC-14004276;http://www.chictr.org.cn/enindex.aspx.
基金This work was supported by a grant from the Natural Science Foundation of China(No.31370211).
文摘Chlamydia trachomatis (Ct) genital infection is the most common sexually transmitted disease (STD) in China and the US. The morbidity of Ct genital infection in China has increased from 32.48/100,000 in 2008 to 37.18/100,000 in 2015.[1] The major areas of Ct infections are concentrated in the Zhujiang Delta, Changjiang Delta, Minjiang Area, and West China. In these areas, the highest incidence of Ct infection reaches 615.99/100,000 citizens. In the US, there are 1,441,789 reported Ct, which include 627.2 females and 278.4 males per 100,000 population. It is now the most prevalent STD, with its rate increasing to 22% in males and 6% in females.[2] Ct genital infection can cause epididymitis, prostatitis, cervicitis, annexitis, infertility, and atopic pregnancy, which have been identified as the major public health problems.
文摘Introduction Shiitake dermatitis (SD) is correlated with the ingestion of raw or undercooked shiitake mushrooms (SMs) and is more common in countries where SMs are habitually eaten.The condition was first reported in Japan by Nakamura in 1977[1] and has since been recorded worldwide.The associated reports are rare in the domestic.This disease is characterized by intensely pruritic isolated or grouped papules or papulovesicles with whiplash-striped,infiltrated erythema that arise in a pattern consistent with the K(o)bner phenomenon because of stripe-like scratching,thus differing the lesions from the immediate onset of dermographism[1].