PMID- 38284697
OWN - NLM
STAT- Publisher
LR  - 20240129
IS  - 1873-4251 (Electronic)
IS  - 1570-162X (Linking)
DP  - 2024 Jan 25
TI  - A Phase-IV Non-interventional Study to Assess Virological Effectiveness, Safety, 
      and Tolerability of DTG-based Antiretroviral Therapy in HIV-1 Infected Indian 
      Persons Living with HIV.
LID - 10.2174/011570162X264021231108010324 [doi]
AB  - BACKGROUND: Dolutegravir (DTG) is a novel yet preferential first-and-second-line 
      treatment for persons living with HIV (PLH). Owing to its recent introduction, 
      DTG-based regimens have not undergone a comprehensive, systematic evaluation 
      regarding their real-world utilization and safety profile among a sizeable Indian 
      population. OBJECTIVE: This study aimed to assess the 24-week immunovirological 
      outcomes, anthropometric and metabolic changes, tolerability, and adverse events 
      (AEs) of DTG-based antiretroviral (ART) regimens. METHODS: A single-centre 
      phase-IV non-interventional observational study involving 322 ART-- naive and 
      treatment-experienced PLH initiating DTG-based-regimens until October 2022 were 
      followed up for outcomes at 24 weeks. RESULTS: At 24 weeks, all PLH (n=113) in 
      the naive group, all PLH (n=67) in the first-line substitution group, 93.9% PLH 
      (n=46) in the first-line failure group, and 95.7% PLH (n=89) in the second- line 
      substitution group were virologically suppressed to plasma HIV-RNA <1000 
      copies/mL. Virological suppression rates to plasma HIV-RNA <200 copies/mL and <50 
      copies/mL were consistent among PLH who received DTG as first- or second-line 
      ART. The mean-unadjusted weight gain observed was 3.5 kg (SE: 0.330), and it was 
      significantly higher in PLH with poorer health at baseline (either HIV-RNA >/= 1000 
      copies/ml or CD4 cell count <350 cells/muL). Overall, 27.3% PLH (n=88) gained >/=10% 
      of their baseline body weight, corresponding to 3.7% incidence (n=10) of 
      treatment-emergent clinical obesity [1]. DTG had an overall lipid-neutral effect, 
      with an advantageous effect being observed in PLH switching from non-nucleoside 
      analogue reverse-transcriptase inhibitors (NNRTI) or ritonavir-boosted protease 
      inhibitors (b/PI), especially in dyslipidemic pre-treated PLH (median change in 
      total cholesterol: 28.5 mg/dL and triglycerides: 51 mg/dL), possibly emanating 
      from the withdrawal of the offending ART. The incidence of DTG-specific AEs, 
      including CNS AEs, was low. Two PLH developed proximal myopathy and one developed 
      transaminitis, warranting DTG discontinuation. Asymptomatic serum-CPK elevation 
      and drug-induced transaminitis were seen in 25.2% (n=27) and 3.2% (n=10) PLH, 
      respectively. No apparent negative effects on renal function were detected. 
      CONCLUSION: Our results from a large Indian cohort indicate a favourable 
      virological and metabolic response, with good tolerance of DTG-based ART at 24 
      weeks.
CI  - Copyright(c) Bentham Science Publishers; For any queries, please email at 
      epub@benthamscience.net.
FAU - Ashta, Kuldeep
AU  - Ashta K
AD  - Department of Medicine, Command Hospital Lucknow, New Delhi, 110010, India.
FAU - Arora, Sumit
AU  - Arora S
AD  - Department of Medicine, Army College of Medical Sciences, New Delhi, 110010, 
      India.
FAU - Khanna, Rajesh
AU  - Khanna R
AD  - Department of Surgery, Army College of Medical Sciences, New Delhi, 110010, 
      India.
FAU - Anilkumar, Anirudh
AU  - Anilkumar A
AD  - Consultant Physician, Department of Clinical Research, DocSy Ltd., New Delhi, 
      110008, India.
FAU - Raman, Nishant
AU  - Raman N
AD  - Base Hospital, New Delhi, 110010, India.
FAU - Mohan, Charu
AU  - Mohan C
AD  - Department of Medicine, Army College of Medical Sciences and Base Hospital, New 
      Delhi, 110010, India.
LA  - eng
PT  - Journal Article
DEP - 20240125
PL  - Netherlands
TA  - Curr HIV Res
JT  - Current HIV research
JID - 101156990
SB  - IM
OTO - NOTNLM
OT  - Acquired immunodeficiency syndrome
OT  - CD4 cell count
OT  - adverse events
OT  - antiretroviral therapy
OT  - body weight
OT  - cholesterol
OT  - dolutegravir
OT  - dyslipidaemia
OT  - efavirenz
OT  - human immunodeficiency virus
OT  - integrase strand-transfer inhibitors
OT  - lamivudine
OT  - lipid profile
OT  - myopathy
OT  - nevirapine
OT  - non-nucleoside analogue reverse transcriptase inhibitors
OT  - nucleoside analogue reverse-transcriptase inhibitors
OT  - protease inhibitors
OT  - tenofovir
OT  - zidovudine.
EDAT- 2024/01/29 12:43
MHDA- 2024/01/29 12:43
CRDT- 2024/01/29 08:45
PHST- 2023/06/11 00:00 [received]
PHST- 2023/09/15 00:00 [revised]
PHST- 2023/09/27 00:00 [accepted]
PHST- 2024/01/29 12:43 [medline]
PHST- 2024/01/29 12:43 [pubmed]
PHST- 2024/01/29 08:45 [entrez]
AID - CHR-EPUB-137960 [pii]
AID - 10.2174/011570162X264021231108010324 [doi]
PST - aheadofprint
SO  - Curr HIV Res. 2024 Jan 25. doi: 10.2174/011570162X264021231108010324.