DOLAMA Study: Effectiveness and Safety of Dual Therapy with Dolutegravir and Lamivudine in Virologically Suppressed HIV-1 Patients

Hidalgo-Tenorio, Carmen; Cort&eacute;s, Luis L&oacute;pez; Guti&eacute;rrez, Alicia; Santos, Jes&uacute;s; Omar, Mohamed; Gálvez, Carmen; Sequera, Sergio; Jesús, Samantha Eisabeth De; Téllez, Francisco; Fernández, Elisa; Garc&iacute;a, Coral; Pasquau, Juan

doi:10.2139/ssrn.3356857

Cited by 25 publications

(57 citation statements)

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“…In this point, a recently reported 2-drug regimen that is safe and cost-effective should be refrained due to the low genetic barrier against HBV. [ 18 ]…”

Section: Discussionmentioning

confidence: 99%

Factors associated with clearance of hepatitis B virus surface antigen in patients infected with human immunodeficiency virus

et al. 2020

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Owing to similar routes of transmission, hepatitis B virus (HBV) and human immunodeficiency virus (HIV) coinfection commonly occurs. Compared with patients infected with only HBV, coinfected patients develop persistent HBV infection followed by advanced liver diseases. However, the characteristics of HIV-infected patients who can achieve the clearance of HBV surface antigen (HBsAg) have not been clarified. In this study, we retrospectively examined patients coinfected with HBV and HIV and determined the host factors associated with HBsAg clearance. Among HIV-infected patients who visited our hospital between 1994 and 2017, we examined medical records of those who were seropositive for HBsAg at least once. Among them, patients who cleared HBsAg afterward were regarded as “cured,” while those who remained HBsAg-seropositive until 2017 were “chronic.” HBsAg seropositivity was found in 57 patients, and among them, 27 male patients were cured whereas 18 were chronic. The cured patients were significantly younger and had higher CD4 cell and platelet counts than the chronic patients. In addition, the cured patients had higher levels of transaminases after the detection of HBsAg. Multivariate analysis revealed age as an independent factor. Analyses of the patients infected with genotype A also showed that the cured patients had significantly higher CD4 cell counts. Considering that the CD4 cell and platelet counts were higher in the cured patients, immunological and liver functions were closely associated with HBsAg clearance. Higher levels of transaminases in the cured patients may also reflect the immunological function leading to HBsAg clearance.

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“…In this point, a recently reported 2-drug regimen that is safe and cost-effective should be refrained due to the low genetic barrier against HBV. [ 18 ]…”

Section: Discussionmentioning

confidence: 99%

Factors associated with clearance of hepatitis B virus surface antigen in patients infected with human immunodeficiency virus

et al. 2020

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“…This analysis included 5017 PWH who were reported to be using dolutegravir plus lamivudine. In 20 studies that reported data for sex, the majority of PWH treated with dolutegravir plus lamivudine were male (range, 60-97%) [29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48]. In five of seven studies with reported racial demographics, C 90% of PWH were identified as White [30,32,33,42,43,46,47].…”

Section: Baseline Characteristicsmentioning

confidence: 99%

HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review

Patel

Evitt

Mariolis³

et al. 2021

Infect Dis Ther

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“…The mean age of PLHIV ranged from 48.5 to 59 years and all PLHIV were treatment-experienced suppressed. Most PLHIV switched from triple therapy [33][34][35]. Some populations also had PLHIV with resistance mutations including the M184I/V mutation for 3TC resistance [33][34][35][36].…”

Section: Dual Therapy With Dtg + 3tcmentioning

confidence: 99%

“…Most PLHIV switched from triple therapy [33][34][35]. Some populations also had PLHIV with resistance mutations including the M184I/V mutation for 3TC resistance [33][34][35][36]. PLHIV in Reynes et al [36] were considered heavily pre-treated, whereas Hidalgo-Tenorio et al [35] and Gagliardini et al [37] included a population with no history of VF.…”

Section: Dual Therapy With Dtg + 3tcmentioning

confidence: 99%

Effectiveness and safety of dolutegravir two‐drug regimens in virologically suppressed people living with HIV: a systematic literature review and meta‐analysis of real‐world evidence

et al. 2021

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Dolutegravir (DTG) is widely recommended within three-drug regimens. However, similar efficacy and tolerability have also been achieved with DTG within two-drug regimens in clinical trials. This study evaluated the real-world effectiveness and discontinuations in people living with HIV-1 (PLHIV) switching to DTG with lamivudine (3TC) or rilpivirine (RPV). MethodsThis was a one-arm meta-analysis utilizing data from a systematic literature review. Data from real-world evidence studies of DTG + RPV and DTG + 3TC were extracted, pooled and analysed. The primary outcome was the proportion of patients with viral failure (VF; ≥ 50 copies/mL in two consecutive measurements and/or ≥ 1000 copies/mL in a single measurement) at week 48 (W48) and week 96 (W96). Other outcomes included virological suppression (VS; < 50 copies/mL) and discontinuations (W48 and W96). Estimates were calculated for VF, VS as per snapshot (VSS) and on treatment analysis (VSOT), and discontinuations. ResultsPooled mean estimates of VF for DTG + 3TC and DTG + RPV were 0.8% [95% confidence interval (CI): 0.4-1.3] and 0.6% (95% CI: 0.0-1.6), respectively, at W48. VSS rate at W48 was 85.0% (95% CI: 82.3-87.5) for DTG + 3TC regimen and 92.4% (95% CI: 85.0-97.7) in the DTG + RPV regimen. The DTG + 3TC and DTG + RPV regimens led to discontinuations in 13.6% (95% CI: 11.1-16.2) and 7.2% (95% CI: 2.1-14.4) of patients, respectively, at W48. Similar results were observed at W96. ConclusionsTreatment with DTG + 3TC or DTG + RPV in clinical practice provides a low rate of VF and a high rate of VS when initiated in virologically suppressed PLHIV with diverse backgrounds.

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DOLAMA Study: Effectiveness and Safety of Dual Therapy with Dolutegravir and Lamivudine in Virologically Suppressed HIV-1 Patients

Cited by 25 publications

References 0 publications

Factors associated with clearance of hepatitis B virus surface antigen in patients infected with human immunodeficiency virus

Factors associated with clearance of hepatitis B virus surface antigen in patients infected with human immunodeficiency virus

HIV Treatment with the Two-Drug Regimen Dolutegravir Plus Lamivudine in Real-world Clinical Practice: A Systematic Literature Review

Effectiveness and safety of dolutegravir two‐drug regimens in virologically suppressed people living with HIV: a systematic literature review and meta‐analysis of real‐world evidence

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