PMID- 38515183
OWN - NLM
STAT- MEDLINE
DCOM- 20240325
LR  - 20240325
IS  - 1742-6405 (Electronic)
IS  - 1742-6405 (Linking)
VI  - 21
IP  - 1
DP  - 2024 Mar 21
TI  - Efficacy and safety of switching to dolutegravir/lamivudine in virologically 
      suppressed people with HIV-1 aged >/= 50 years: week 48 pooled results from the 
      TANGO and SALSA studies.
PG  - 17
LID - 10.1186/s12981-024-00604-9 [doi]
LID - 17
AB  - BACKGROUND: As the population of people with HIV ages, concerns over managing 
      age-related comorbidities, polypharmacy, immune recovery, and drug-drug 
      interactions while maintaining viral suppression have arisen. We present pooled 
      TANGO and SALSA efficacy and safety results dichotomized by age (< 50 
      and >/= 50 years). METHODS: Week 48 data from the open-label phase 3 TANGO and 
      SALSA trials evaluating switch to once-daily dolutegravir/lamivudine (DTG/3TC) 
      fixed-dose combination vs continuing current antiretroviral regimen (CAR) were 
      pooled. Proportions of participants with HIV-1 RNA >/= 50 and < 50 copies/mL 
      (Snapshot, intention-to-treat exposed) and safety were analyzed by age category. 
      Adjusted mean change from baseline in CD4 + cell count was assessed using 
      mixed-models repeated-measures analysis. RESULTS: Of 1234 participants, 80% of 
      whom were male, 29% were aged >/= 50 years. Among those aged >/= 50 years, 1/177 
      (< 1%) DTG/3TC participant and 3/187 (2%) CAR participants had HIV-1 RNA >/= 50 
      copies/mL at 48 weeks; proportions with HIV-1 RNA < 50 copies/mL were high in 
      both treatment groups (>/= 92%), consistent with overall efficacy and similar to 
      observations in participants aged < 50 years (>/= 93%). Regardless of age category, 
      CD4 + cell count increased or was maintained from baseline with DTG/3TC. Change 
      from baseline in CD4 + /CD8 + ratio was similar across age groups and between 
      treatment groups. One CAR participant aged < 50 years had confirmed virologic 
      withdrawal, but no resistance was detected. In the DTG/3TC group, incidence of 
      adverse events (AEs) was similar across age groups. Proportions of AEs leading to 
      withdrawal were low and comparable between age groups. Although drug-related AEs 
      were generally low, across age groups, drug-related AEs were more frequent in 
      participants who switched to DTG/3TC compared with those who continued CAR. While 
      few serious AEs were observed in both treatment groups, more were reported in 
      participants aged >/= 50 years vs < 50 years. CONCLUSIONS: Among individuals with 
      HIV-1, switching to DTG/3TC maintained high rates of virologic suppression and 
      demonstrated a favorable safety profile, including in those aged >/= 50 years 
      despite higher prevalence of concomitant medication use and comorbidities. TRIAL 
      REGISTRATION NUMBER: TANGO, NCT03446573 (February 27, 2018); SALSA, NCT04021290 
      (July 16, 2019).
CI  - (c) 2024. The Author(s).
FAU - Walmsley, Sharon
AU  - Walmsley S
AD  - University Health Network, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada.
FAU - Smith, Don E
AU  - Smith DE
AD  - Albion Centre, 150 Albion Street, Surry Hills NSW 2010, Sydney, Australia.
FAU - Gorgolas, Miguel
AU  - Gorgolas M
AD  - Fundacion Jimenez Diaz, Universidad Autonoma de Madrid, Av. de los Reyes 
      Catolicos, 2, 28040, Madrid, Spain.
FAU - Cahn, Pedro E
AU  - Cahn PE
AD  - Fundacion Huesped, Dr. Carlos A. Gianantonio 3932, C1204 CABA, Buenos Aires, 
      Argentina.
FAU - Lutz, Thomas
AU  - Lutz T
AD  - Infektiologikum, Stresemannallee 3, 60596, Frankfurt am Main, Frankfurt, Germany.
FAU - Lacombe, Karine
AU  - Lacombe K
AD  - Hopital Saint-Antoine, 184 Rue du Faubourg Saint-Antoine, 75012, Paris, France.
FAU - Kumar, Princy N
AU  - Kumar PN
AD  - Georgetown University Medical Center, 4000 Reservoir Road, NW, Washington, DC, 
      20057, USA.
FAU - Wynne, Brian
AU  - Wynne B
AD  - ViiV Healthcare, 406 Blackwell Street, Suite 300, Durham, NC, 27701, USA.
FAU - Grove, Richard
AU  - Grove R
AD  - GSK, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.
FAU - Bontempo, Gilda
AU  - Bontempo G
AD  - ViiV Healthcare, 36 E Industrial Road, Branford, CT, 06405, USA.
FAU - Moodley, Riya
AU  - Moodley R
AD  - ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.
FAU - Okoli, Chinyere
AU  - Okoli C
AD  - ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.
FAU - Kisare, Michelle
AU  - Kisare M
AD  - ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK. 
      michelle.o.kisare@viivhealthcare.com.
FAU - Jones, Bryn
AU  - Jones B
AD  - ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.
FAU - Clark, Andrew
AU  - Clark A
AD  - ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.
FAU - Ait-Khaled, Mounir
AU  - Ait-Khaled M
AD  - ViiV Healthcare, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT03446573
SI  - ClinicalTrials.gov/NCT04021290
PT  - Journal Article
DEP - 20240321
PL  - England
TA  - AIDS Res Ther
JT  - AIDS research and therapy
JID - 101237921
RN  - 2T8Q726O95 (Lamivudine)
RN  - DKO1W9H7M1 (dolutegravir)
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Heterocyclic Compounds, 3-Ring)
RN  - 0 (Anti-Retroviral Agents)
RN  - 63231-63-0 (RNA)
RN  - 0 (Oxazines)
RN  - 0 (Piperazines)
RN  - 0 (Pyridones)
SB  - IM
MH  - Humans
MH  - Male
MH  - Female
MH  - Lamivudine/adverse effects
MH  - *HIV-1
MH  - *Anti-HIV Agents/adverse effects
MH  - *HIV Infections/drug therapy
MH  - Heterocyclic Compounds, 3-Ring/adverse effects
MH  - Anti-Retroviral Agents/therapeutic use
MH  - *HIV Seropositivity/drug therapy
MH  - RNA
MH  - *Oxazines
MH  - *Piperazines
MH  - *Pyridones
PMC - PMC10958962
OTO - NOTNLM
OT  - Aging
OT  - Comorbidity
OT  - DTG/3TC
OT  - HIV-1
OT  - Polypharmacy
OT  - Single-tablet regimen
OT  - Suppressed switch
OT  -  >/= 50 years
COIS- SW has received investigator-initiated grants from Gilead Sciences, Merck, and 
      ViiV Healthcare and has participated in advisory boards for Merck and ViiV 
      Healthcare. DES has served as a consultant for Gilead Sciences and ViiV 
      Healthcare. MG has received grants from Janssen and ViiV Healthcare and 
      consulting fees and honoraria from Janssen, Gilead Sciences, and ViiV Healthcare. 
      PEC has received consulting fees from Gilead Sciences, MSD, and ViiV Healthcare 
      and honoraria from Gilead Sciences and ViiV Healthcare, and has participated in 
      data safety monitoring or advisory boards for Moderna. TL has received funding 
      from GSK, paid to his institution, and grants from Charite Berlin, DAGNA e.V., 
      Gilead Sciences, Heidelberg ImmunoTherapeutics GmbH, Leberstiftungs-GmbH, 
      Moderna, and MSD, paid to his institution. KL has received honoraria and travel 
      support from Gilead Sciences, MSD, and ViiV Healthcare. PNK has received grants 
      from Gilead Sciences, GSK, Merck, TheraTechnologies, and ViiV Healthcare, paid to 
      her institution; has received consulting fees from Gilead Sciences, GSK, Merck, 
      and ViiV Healthcare; has participated in data safety monitoring or advisory 
      boards for Gilead Sciences, GSK, Merck, and ViiV Healthcare; and holds stock or 
      stock options in Gilead Sciences, GSK, Johnson & Johnson, Merck, Moderna, and 
      Pfizer. BW, RG, GB, RM, CO, MK, BJ, AC, and MA-K are employees of ViiV Healthcare 
      or GSK and may own stock in GSK.
EDAT- 2024/03/22 06:45
MHDA- 2024/03/25 06:42
PMCR- 2024/03/21
CRDT- 2024/03/22 01:43
PHST- 2023/12/13 00:00 [received]
PHST- 2024/03/13 00:00 [accepted]
PHST- 2024/03/25 06:42 [medline]
PHST- 2024/03/22 06:45 [pubmed]
PHST- 2024/03/22 01:43 [entrez]
PHST- 2024/03/21 00:00 [pmc-release]
AID - 10.1186/s12981-024-00604-9 [pii]
AID - 604 [pii]
AID - 10.1186/s12981-024-00604-9 [doi]
PST - epublish
SO  - AIDS Res Ther. 2024 Mar 21;21(1):17. doi: 10.1186/s12981-024-00604-9.