Abstract
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.
MethodsWe 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%.
ResultsAt 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.
ConclusionsThe 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 registrationClinicalTrials.gov Identifier: NCT02369965; https://www.clinicaltrials.gov.
Chinese Clinical Trial Registry No. ChiCTR-TRC-14004276; http://www.chictr.org.cn/enindex.aspx
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Details
1 Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China
2 Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China
3 Department of Infectious Diseases, Infectious Disease Hospital of Henan Province, Zhengzhou, Henan 450061, China
4 Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, Guangdong 510060, China
5 Institute of HIV/AIDS, The First Hospital of Changsha, Changsha, Hunan 410005, China
6 Department of Infectious Diseases, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China
7 Department of Infectious Diseases, National Clinical Center for Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen, Guangdong 518112, China
8 Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, China
9 Department of Infectious Diseases, Xixi Hospital of Hangzhou, Hangzhou, Zhejiang 310023, China
10 State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang 310003, China
11 National Clinical Research Center for Infectious Diseases, the Fifth Medical Center of PLA General Hospital, Beijing 100039, China
12 Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical University, Xi’an, Shaanxi 710038, China
13 Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
14 Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
15 Beijing Co-CRO Medical Development Co., Ltd., Beijing 100711, China
16 State Key Laboratory for Infectious Disease Prevention and Control, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China