Tesi etd-10062025-184934 |
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Tipo di tesi
Tesi di specializzazione (4 anni)
Autore
COLOMBAIONI, SILVIA
URN
etd-10062025-184934
Titolo
Risk of virological failure after switch to a tenofovir-sparing dual therapy in virologically suppressed people with HIV and past HBV infection.
Dipartimento
MEDICINA CLINICA E SPERIMENTALE
Corso di studi
MALATTIE INFETTIVE E TROPICALI
Relatori
relatore Prof. Borghetti, Alberto
Parole chiave
- antiretroviral therapy
- emulation trial
- HIV
- prior HBV
Data inizio appello
06/11/2025
Consultabilità
Non consultabile
Data di rilascio
06/11/2028
Riassunto
Background - We compared the effectiveness of tenofovir (TFV)-based triple regimens (TT) to TFV-sparing dual therapies (DT) in virologically suppressed, HBsAg-/ HBcAb+ people living with HIV (PLWH).
Methods - We emulated a target trial including adults PLWH from 5 University Hospitals, with HBsAg-/HBcAb+ serostatus, starting a TT with unsuppressed serum HIV-RNA and reaching HIV-RNA<50 cp/mL (baseline). PLWH starting a DT (3TC+bPI or DTG, DTG+RPV, DOR+DTG or long-acting CAB+RPV) were considered in the “treatment”-group only if they switched within 1 year-grace period; all other PLWH were considered “control”-group. To emulate randomisation, participants were cloned at baseline and assigned the opposite strategy, then censored at the time of strategy-deviation and assigned a weight based on the inverse-probability of being uncensored. Probabilities of 5-years virological failure (VF, 2 consecutive HIV-RNA>50 cp/mL or a single HIV-RNA≥200 cp/mL) were estimated through weighted Kaplan-Meier estimator.
Results - Overall, 415 PLWH were eligible for study analysis: 71 (17.1%) started a DT (3TC-based: 78.9%) during follow-up. They were mainly men (329, 79.3%), with 48 years-median age. In the weighted analysis, the estimated probabilities of VF were: 29.3% for DT and 29.9% for TT at 5 years (difference: 0.5%). A higher VF risk was seen in the subset of PLWH with undetectable HBsAb at the longest follow-up available (4 years), independently from treatment group: 15.5% and 36.8% with DT and TT, respectively.
Conclusion - Switching to a TFV-sparing DT, compared with continuing a TT, was not associated with an increased risk of VF in PLWH and prior HBV infection.
Methods - We emulated a target trial including adults PLWH from 5 University Hospitals, with HBsAg-/HBcAb+ serostatus, starting a TT with unsuppressed serum HIV-RNA and reaching HIV-RNA<50 cp/mL (baseline). PLWH starting a DT (3TC+bPI or DTG, DTG+RPV, DOR+DTG or long-acting CAB+RPV) were considered in the “treatment”-group only if they switched within 1 year-grace period; all other PLWH were considered “control”-group. To emulate randomisation, participants were cloned at baseline and assigned the opposite strategy, then censored at the time of strategy-deviation and assigned a weight based on the inverse-probability of being uncensored. Probabilities of 5-years virological failure (VF, 2 consecutive HIV-RNA>50 cp/mL or a single HIV-RNA≥200 cp/mL) were estimated through weighted Kaplan-Meier estimator.
Results - Overall, 415 PLWH were eligible for study analysis: 71 (17.1%) started a DT (3TC-based: 78.9%) during follow-up. They were mainly men (329, 79.3%), with 48 years-median age. In the weighted analysis, the estimated probabilities of VF were: 29.3% for DT and 29.9% for TT at 5 years (difference: 0.5%). A higher VF risk was seen in the subset of PLWH with undetectable HBsAb at the longest follow-up available (4 years), independently from treatment group: 15.5% and 36.8% with DT and TT, respectively.
Conclusion - Switching to a TFV-sparing DT, compared with continuing a TT, was not associated with an increased risk of VF in PLWH and prior HBV infection.
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