PMID- 35570525 OWN - NLM STAT- MEDLINE DCOM- 20220919 LR - 20221027 IS - 1873-4251 (Electronic) IS - 1570-162X (Linking) VI - 20 IP - 3 DP - 2022 TI - Dolutegravir Plus Lamivudine as Initial Therapy for HIV-1 Infected and ARV-naive Patients in West China, 24-Weeks Results of a Preliminary Real-world Study. PG - 222-227 LID - 10.2174/1570162X20666220514165728 [doi] AB - INTRODUCTION: This preliminary real-world study (RWS) was designed to evaluate the antiviral efficacy, safety, and feasibility of the 2-drug regimen (2DR), dolutegravir plus lamivudine as the initial antiretroviral therapy (ART) among antiretroviral (ARV)-naive adults with HIV-1 in West China. METHODS: This RWS included the treatment of treatment-naive adults applying 2DR of dolutegravir 50 mg once daily (QD) plus lamivudine 300mg QD with negative HBsAg from one single center of People's Hospital of Chongqing Banan District in West China. Viral load (VL), CD4+ T-cell count, and laboratory indicators were collected at baseline; weeks 4, 12, and 24, and thereafter every 24 weeks up to 144 weeks. The primary endpoint was the proportion of patients with HIV-1 RNA <50 copies/mL at week 24. RESULTS: A total of 54 ART-naive patients were treated with the 2-drug regimen of DTG plus 3TC and were enrolled in this study since April 1st, 2020. Twenty-one patients received 24-week VL tests at screening as required by inclusion criteria. Median HIV-1 RNA at entry was 95,700 copies/ mL (interquartile range (IQR): 28,300-310,000) and the median baseline CD4+ cell count was 249 per cubic millimetre(IQR: 118-310). At week 24, 15 (71.4%) of 21 participants achieved virological success, defined as HIV-1 RNA < 50 copies/mL, while 10 (90.9%) of 11 participants with a baseline HIV-1 RNA < 100,000 copies/mL achieved virological success compared with 5 (50%) of 10 participants with a baseline HIV-1 RNA >/=100,000 copies/mL [Relative Risk (RR) 1.818; 95% CI 1.018-1.927]. In participants with CD4+ cell counts >/= 200 cells/mm3, 9 (75%) of 12 participants achieved virological success compared with 6 (66.7%) of 9 participants with baseline CD4+ cell count < 200 cells/mm3 achieved it (RR 1.124; 95% CI 0.641-1.970). No major tolerability/toxicity issues were observed. CONCLUSION: This real-world study suggested that the 2-drug regimen of DTG plus 3TC could be considered as an alternative for ART-naive patients in West China, especially with HIV-1 RNA less than 100,000 copies/mL at baseline, regarding the limits of viral load test frequency and the absence of HIV genotypic testing of viral resistance. CI - Copyright(c) Bentham Science Publishers; For any queries, please email at epub@benthamscience.net. FAU - Hui, Xia AU - Hui X AD - Department of Infection, People's hospital of Chongqing Banan District, Chongqing, China. FAU - Gan, Xinrong AU - Gan X AD - Department of Infection, People's hospital of Chongqing Banan District, Chongqing, China. FAU - Li, Qian AU - Li Q AD - Department of Infection, People's hospital of Chongqing Banan District, Chongqing, China. FAU - Sun, Wei AU - Sun W AD - Department of Infection, People's hospital of Chongqing Banan District, Chongqing, China. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - Netherlands TA - Curr HIV Res JT - Current HIV research JID - 101156990 RN - 0 (Anti-HIV Agents) RN - 0 (Anti-Retroviral Agents) RN - 0 (Antiviral Agents) RN - 0 (Hepatitis B Surface Antigens) RN - 0 (Heterocyclic Compounds, 3-Ring) RN - 0 (Oxazines) RN - 0 (Piperazines) RN - 0 (Pyridones) RN - 0 (RNA, Viral) RN - 2T8Q726O95 (Lamivudine) RN - 63231-63-0 (RNA) RN - DKO1W9H7M1 (dolutegravir) SB - IM MH - Adult MH - *Anti-HIV Agents/adverse effects MH - Anti-Retroviral Agents/therapeutic use MH - Antiviral Agents/therapeutic use MH - Drug Therapy, Combination MH - *HIV Infections/drug therapy MH - *HIV Seropositivity/drug therapy MH - *HIV-1/genetics MH - Hepatitis B Surface Antigens/therapeutic use MH - Heterocyclic Compounds, 3-Ring/adverse effects MH - Humans MH - Lamivudine/adverse effects MH - Oxazines MH - Piperazines MH - Pyridones MH - RNA/therapeutic use MH - RNA, Viral MH - Viral Load OTO - NOTNLM OT - 2-drug regimen OT - HIV OT - dolutegravir plus lamivudine OT - effectiveness OT - integrase strand transfer inhibitor OT - simplification EDAT- 2022/05/17 06:00 MHDA- 2022/09/20 06:00 CRDT- 2022/05/16 02:43 PHST- 2021/11/09 00:00 [received] PHST- 2022/02/22 00:00 [revised] PHST- 2022/03/16 00:00 [accepted] PHST- 2022/05/17 06:00 [pubmed] PHST- 2022/09/20 06:00 [medline] PHST- 2022/05/16 02:43 [entrez] AID - CHR-EPUB-123571 [pii] AID - 10.2174/1570162X20666220514165728 [doi] PST - ppublish SO - Curr HIV Res. 2022;20(3):222-227. doi: 10.2174/1570162X20666220514165728.