Efficacy and safety of a single-tablet regimen containing tenofovir disoproxil fumarate 300 mg, lamivudine 300 mg and efavirenz 400 mg as a switch strategy in virologically suppressed HIV-1-infected subjects on nonnucleoside reverse transcriptase inhibitor-containing first-line antiretroviral therapy in Pune, India.
Adult
Alkynes
/ administration & dosage
Benzoxazines
/ administration & dosage
CD4 Lymphocyte Count
Cyclopropanes
/ administration & dosage
Drug Combinations
Female
HIV Infections
/ drug therapy
HIV-1
/ drug effects
Humans
India
Lamivudine
/ administration & dosage
Male
Middle Aged
Private Sector
Retrospective Studies
Reverse Transcriptase Inhibitors
/ therapeutic use
Tablets
Tenofovir
/ administration & dosage
Tertiary Care Centers
Treatment Outcome
Viral Load
India
antiretroviral therapy optimization
cost‐effectiveness
efavirenz 400 mg
single‐tablet regimen
Journal
HIV medicine
ISSN: 1468-1293
Titre abrégé: HIV Med
Pays: England
ID NLM: 100897392
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
received:
08
02
2020
revised:
22
04
2020
accepted:
10
06
2020
entrez:
6
10
2020
pubmed:
7
10
2020
medline:
23
11
2021
Statut:
ppublish
Résumé
As per National AIDS Control Organization (NACO) estimates, there are 2.1 million people living with HIV (PWH) in India, of whom 1.2 million are on first-line antiretroviral therapy (ART). This study explored the use of a single-tablet regimen containing tenofovir disoproxil fumarate 300 mg + lamivudine 300 mg + efavirenz 400 mg (TLE400 STR) as a first-line switch strategy in PWH in Pune, India. This retrospective cohort study was conducted in private sector ART clinics in three tertiary-level hospitals in Pune, India. PWH > 12 years of age (n = 502) who initiated first-line ART (predominantly TLE600 STR), completed ≥ 6 months of follow-up and achieved virological suppression [plasma viral load (VL) < 1000 HIV-1 RNA copies/mL] were identified and switched to TLE400 STR. The virological and immunological efficacy of TLE400 STR at 6 and 12 months of follow-up were noted. Grade 3/4 adverse events (especially efavirenz-related neuropsychiatric adverse events) leading to regimen discontinuation were also noted. Of 502 PWH who switched to TLE400 STR, complete virological suppression (VL < 20 copies/mL) was maintained in more than 97% of patients at follow-up. TLE400 STR was successful in maintaining CD4 counts within the range observed at the start of the regimen. Grade 3/4 adverse events leading to TLE400 STR discontinuation were seen in 11 (2.2%) patients. Virological failure (VL > 1000 copies/mL) and treatment regimen failure were seen in six (1.2%) and 49 (9.8%) subjects, respectively. TLE400 STR exhibits excellent efficacy and safety as a switch strategy and should be introduced in the Indian National ART Program, especially for PWH who are virologically suppressed on TLE600 STR.
Identifiants
pubmed: 33021066
doi: 10.1111/hiv.12912
pmc: PMC7539943
doi:
Substances chimiques
Alkynes
0
Benzoxazines
0
Cyclopropanes
0
Drug Combinations
0
Reverse Transcriptase Inhibitors
0
Tablets
0
Lamivudine
2T8Q726O95
Tenofovir
99YXE507IL
efavirenz
JE6H2O27P8
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
578-587Informations de copyright
© 2020 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of British HIV Association.
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