Doravirine Use in Treatment-Experienced HIV-Positive Patients

Fulco, Patricia Pecora; Herity, Leah B.

doi:10.1177/1060028020935763

Cited by 6 publications

(10 citation statements)

References 6 publications

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“…Overall mortality was more elevated compared with previous case series 4 (30.2%), probably in relation to the greater percentage of hemorrhagic stroke, whose mortality is more elevated both in HIV and non-HIV infected patients. We think that it is remarkable that the mortality rate in ischemic stroke was of 27%, compared with the 9.4% rate in non-HIV patients in our center.…”

Section: Prognosis Of Stroke Among People Living With Hiv and Its Rel...contrasting

confidence: 64%

“…These preliminary data seem to confirm the genetic barrier of DOR, especially when compared with previous NNRTIs. 3,4 In line with results from the DRIVE-SHIFT study, 1 a trend toward reduction in fasting lipids was observed at 24 weeks from the switch. Interestingly, we observed significant reduction in serum creatinine after 24 weeks; this finding has not been reported in the results of the DRIVE-SHIFT trial.…”

supporting

confidence: 62%

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

Ciccullo

D’Angelillo

Iannone

et al. 2021

JAIDS Journal of Acquired Immune Deficiency Syndromes

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Section: Prognosis Of Stroke Among People Living With Hiv and Its Rel...contrasting

confidence: 64%

supporting

confidence: 62%

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

Ciccullo

D’Angelillo

Iannone

et al. 2021

JAIDS Journal of Acquired Immune Deficiency Syndromes

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“…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%

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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“…The DRIVE SHIFT study suggests that virologically suppressed patients can safely be switched to doravirine‐containing regimens, although the follow‐up period in this study was short (24 weeks) [25]. A small retrospective analysis of 16 patients who were switched to doravirine also suggests that patients with pre‐existing NNRTI resistance are able to maintain virological suppression for up to six months [26]. Of note, none of these patients experienced failure on NNRTI‐based regimens and only five of them presented with at least one NNRTI DRM at the time of switch.…”

Section: Resultsmentioning

confidence: 99%

Is there a role for doravirine in African HIV treatment programmes? A large observational resistance study in South Africa

et al. 2021

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Introduction Dolutegravir has replaced efavirenz in most low‐ and middle‐income countries, due to better tolerability and formidable resistance profile, but dolutegravir side effects suggest alternatives are needed. We evaluated doravirine resistance in South Africa as a first step to assess whether doravirine may replace dolutegravir. Methods A retrospective dataset was analysed for predicted doravirine susceptibility, including sequences obtained from three patient groups. First, data from 277 patients initiating antiretroviral treatment (ART) were collected between February 2013 and October 2014 as part of a national survey. Second, data from 788 patients experiencing NNRTI‐based ART failure were obtained between February 2013 and October 2014 as part of a national survey. Third, data derived from 584 patients who had genotypic drug resistance testing requested after NNRT‐based failure as part of individual patient management between January 2016 and December 2019. Pol sequences were generated using validated population‐based in‐house genotyping and submitted to Stanford HIVdb v8.9. Results and discussion Less than 5% of patients initiating ART presented with genotypic doravirine resistance, whereas most patients experiencing NNRTI‐based ART failure presented with predicted intermediate (41.0%) or high‐level resistance (43.8%) to doravirine. High‐level resistance to doravirine was commonly predicted by the presence of at least three DRMs (79.7%). The predicted resistance profile to doravirine in ART‐naïve patients is promising, but less so in those experiencing failure to first‐generation NNRTIs. Accumulation of NNRTI DRMs seems to be an important factor in the poor resistance prediction for doravirine. Conclusions Although doravirine is approved as initial therapy in patients who are ART‐naïve, it is currently recommended to obtain a genotype prior to the initiation of ART. Clinical studies are needed to ascertain whether predicted resistance profiles in ART naïve and NNRTI‐treated patients translate into poor clinical outcomes, especially in settings where genotypic resistance testing is not available.

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Doravirine Use in Treatment-Experienced HIV-Positive Patients

Cited by 6 publications

References 6 publications

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

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

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

Is there a role for doravirine in African HIV treatment programmes? A large observational resistance study in South Africa

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