Real-Life Safety of Doravirine in Treatment-Experienced, Virologically Suppressed PLWHIV

Ciccullo, Arturo; D’Angelillo, Anna; Iannone, Valentina; Farinacci, Damiano; Lombardi, Francesca; Visconti, Elena; Tamburrini, Enrica; Giambenedetto, Simona Di

doi:10.1097/qai.0000000000002730

Cited by 15 publications

(13 citation statements)

References 5 publications

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“…This approach is consistent with other studies, in whom the main reasons for the switch were high cardiovascular/metabolic risk, treatment simplification, drug-to-drug interaction and toxicity. [14][15][16] This suggests that clinicians look at DOR as a drug useful to improve the management of metabolic issues in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…Data regarding the use of this new NNRTI in a real-life setting are still scarce, [14][15][16] and it is important to define how clinicians have interpreted the role of DOR in the current HIV armamentarium. Therefore, this study aimed to describe the reasons leading clinicians to switch patients to a DOR-containing regimen and its role in clinical practice.…”

Section: Fc Is Principal Investigator (Honorary) In Clinical Studies ...mentioning

confidence: 99%

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Real-life use of Doravirine in treatment-experienced people living with HIV: A multicenter Italian study

Mazzitelli¹,

Antoni

Castelli

et al. 2022

Medicine

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Use of doravirine (DOR), a new nonnucleoside reverse-transcriptase inhibitors recently approved for HIV treatment, is still unclear in clinical practice and real-life data are scarce.We retrospectively investigated the rationale for switching people with HIV to DOR-containing/-based regimens in a real-life cohort. Among 132 patients (68.9% males, median age 56 years), the main reasons to start DOR were prevention of toxicities (39.4%) and dyslipidemia (18.2%). DOR was combined with integrase inhibitors in 40.9% cases, and in 25.7% of patients, DOR was prescribed without availability of a genotypic resistance test.Twenty-four weeks after the switch to DOR-containing/-based regimens, no significant changes in CD4+ T-cell count, CD4/ CD8 ratio, detectable HIV-RNA, serum creatinine levels, and body weight were detected. By contrast, a significant reduction in lipids (both cholesterol and triglycerides) was observed in 52 patients for whom a follow-up assessment was available (P = .008 and .01, respectively).Our data confirmed that switching to DOR-containing/-based regimens may have a favorable impact on lipid profile and a neutral impact on weight gain. However, more data are needed to support its use in patients who do not have a genotypic test available or have an extensive nonnucleoside reverse-transcriptase inhibitors-associated resistance, as well as its use in a dual regimen, especially in combination with second-generation integrase inhibitors.

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Section: Discussionmentioning

confidence: 99%

Section: Fc Is Principal Investigator (Honorary) In Clinical Studies ...mentioning

confidence: 99%

Real-life use of Doravirine in treatment-experienced people living with HIV: A multicenter Italian study

Mazzitelli¹,

Antoni

Castelli

et al. 2022

Medicine

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“…In the survival analysis, estimated probability of maintaining doravirine was 93.8% after 6 months and 80.4% after 12 months. 11…”

Section: Discussionmentioning

confidence: 99%

Doravirine/lamivudine/tenofovir disoproxil fumarate in virologically suppressed people living with HIV: A real-life experience

et al. 2023

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Background Doravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) showing high efficacy and tolerability in both naïve and experienced people living with HIV (PLWHIV) in randomized trials, but scarce data are available to date from the real-life experience. Methods We performed an observational, retrospective study of PLWHIV on suppressive antiretroviral therapy who switched to a daily single-tablet regimen containing doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg. Results As a whole, 62 suppressed patients (51 men, median age, 51.7 years; median CD4 T+ lymphocyte count, 577 cells/mm3) were enrolled. After 12 months, 58 (93.5%) patients showed HIV RNA <20 copies/mL and reasons for treatment failure were virological failure in one case, missing data in one case, and adverse events in two cases. At month 12, a significant decrease in median serum level of triglycerides (median change −61.2 mg/dL; p = .009) and total cholesterol (median change −38.4 mg/dL; p = .021) was reported, while a not significant median weight increase was registered (+0.55 kg). Conclusions In our study, simplification to a single-tablet regimen of doravirine/lamivudine/tenofovir disoproxil fumarate in virologically suppressed PLWHIV was effective and showed a good tolerability profile, in association with a significant improvement in serum lipid levels.

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“…Many first-line regimens have been downgraded to alternative regimens since other more effective and better-tolerated treatments have been approved [ 9 , 10 , 11 , 12 , 13 , 14 , 15 ]. In particular, all protease inhibitors (PI) (lopinavir/ritonavir [LPV/r], atazanavir/ritonavir [ATV/r], and darunavir ritonavir or cobicistat [DRV/r or /c]), are not recommended for naïve PWH; only DRV/ is suggested as alternative regimens, and in treatment switch [ 16 ].…”

Section: Introductionmentioning

confidence: 99%

“…However, in the last few years, the scientific community focused on this class’s possible role in weight gain, particularly dolutegravir (DTG) [ 11 , 21 , 23 , 24 ]. Regarding Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI), only rilpivirine (RPV) and doravirine (DOR) are recommended by EACS guidelines, thanks to their excellent efficacy and safety [ 14 , 25 , 26 , 27 , 28 ].…”

Section: Introductionmentioning

confidence: 99%

Causes of HIV Treatment Interruption during the Last 20 Years: A Multi-Cohort Real-Life Study

Vito

Ricci

Menzaghi

et al. 2023

Viruses

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In the last years, many antiretroviral drugs (ART) have been developed with increased efficacy. Nowadays, the main reasons for treatment switches are adverse events, proactive strategy or simplification. We conducted a retrospective cohort study to investigate the reason for treatment interruption in the last 20 years. We merged data of eight cohorts of the SCOLTA project: lopinavir/r (LPV), atazanavir/r (ATV), darunavir/r or /c (DRV), rilpivirine (RPV), raltegravir (RAL), elvitegravir/c (EVG), dolutegravir (DTG) and bictegravir (BIC). We included 4405 people with HIV (PWH). Overall, 664 (15.1%), 489 (11.1%), and 271 (6.2%) PWH interrupted the treatment in the first, second, and third years after starting a new ART. Looking at the interruption in the first year, the most frequent causes were adverse events (3.8%), loss to follow-up (3.7%), patients’ decisions (2.6%), treatment failure (1.7%), and simplification (1.3%). In the multivariate analysis regarding experienced patients, treatment with LPV, ATV, RPV or EVG/c, having less than 250 CD4 cells/mL, history of intravenous drug use, and HCV positivity were associated with an increased risk of interruption. In naive people, only LPV/r was associated with an increased risk of interruption, while RPV was associated with a lower risk. In conclusion, our data on more than 4400 PWH show that adverse events have represented the most frequent cause of treatment interruptions in the first year of ART (3.84%). Treatment discontinuations were more frequent during the first year of follow-up and decreased thereafter. First-generation PI in both naïve and experienced PWH, and EVG/c, in experienced PWH, were associated with a higher risk of treatment interruptions.

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Real-Life Safety of Doravirine in Treatment-Experienced, Virologically Suppressed PLWHIV

Cited by 15 publications

References 5 publications

Real-life use of Doravirine in treatment-experienced people living with HIV: A multicenter Italian study

Real-life use of Doravirine in treatment-experienced people living with HIV: A multicenter Italian study

Doravirine/lamivudine/tenofovir disoproxil fumarate in virologically suppressed people living with HIV: A real-life experience

Causes of HIV Treatment Interruption during the Last 20 Years: A Multi-Cohort Real-Life Study

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