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Weight change

DELSTRIGO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]
PIFELTRO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland) [External links]

Doravirine/3TC/TDF = DELSTRIGO (doravirine/lamivudine/tenofovir disoproxil fumarate)

Doravirine: Weight change data. A post hoc analysis

 

Participants in the DRIVE SHIFT study switched from a baseline regimen consisting of 2 NRTIs in combination with a PI plus either ritonavir or cobicistat, or elvitegravir plus cobicistat, or an NNRTI to DELSTRIGO (doravirine/3TC/TDF)1

Primary efficacy endpoint

The proportion of participants with HIV-1 RNA <50 copies/ml at Week 48 in the immediate switch group compared to Week 24 in the delayed switch group.1

Findings: Modest weight gain after more than 2 years on doravirine/3TC/TDF which would be no higher than that expected in an otherwise healthy population.2

  • The adjusted mean weight gain was 1.4 kg at ~ 2.8 years after switch in the immediate switch group and 1.2 kg at ~ 2.3 years after switch in the delayed switch group2

Mean adjusted weight change after switch to doravirine/3TC/TDF

Study group = immediate switch group (n=438)

immediate switch group graph

Study group = delayed switch group (n=209)

delayed switch group graph

Adapted from Kumar P et al. 20212

Adjusted for weight at time of switch, race (Black/non-Black), ethnicity (Hispanic/other), sex, age, prior therapy class, baseline CD4+ T-cell count, and baseline HIV-1 RNA

§Delayed Switch Group switched to doravirine/3TC/TDF at week 24

Proportion of participants by percent change in weight at Week 144

dorav-drive-shift-graph

Adapted from Kumar P et al. 20212

Immediate Switch Group

Delayed Switch Group

From time of switch to Week 1442
~70% gained less than 5%,
~20% gained 5-10%, and
~8% gained 10% or more

Changes in weight and body mass index with first-line doravirine-based therapy: a pooled analysis of three randomised controlled trials3

 

Distribution of participants by percent change in weight (<5%, ≥5% to <10%, ≥10% ). Doravirine (DOR); ritonavir-boosted darunavir (DRV+r); efavirenz (EFV).3

Changes in weight and BMI with first-line doravirine – based therapy

Adapted from Orkin et al. 20203

  • A pooled analysis of 3 randomised controlled studies of doravirine in treatment naïve adults with HIV-1 evaluated changes in weight and BMI at weeks 48 and 96
  • The pooled analysis compared participants on Doravirine + 2 NRTIs (n=855), efavirenz+ 2 NRTIs (n=472) and darunavir + ritonavir + 2 NRTIs (n=383)1
  • Weight gain experienced across all treatment groups was low and similar through to week 96 of treatment
  • Weight gain experienced is similar to the average yearly change of 0.5-1.0 kg in adults without HIV-1
  • No significant difference between treatment groups in the proportion of participants with ≥10% weight gain through to week 96 of treatment
  • Low CD4+ T-cell count and high HIV-1 RNA at baseline were associated with ≥10% weight gain
  • Doravirine is available as a complete regimen combined with two established NRTIs (3TC/TDF) or as a single agent to be used as part of a regimen with other antiretrovirals
  • When assessing a person's cardiometabolic risk factors including weight and lipids each component of the antiretroviral treatment regimen should be considered

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Tenofovir alafenamide vs. tenofovir disoproxil fumarate: an updated meta-analysis of 14 894 patients across 14 trials

 

PIFELTRO® Prescribing information GB / NI
DELSTRIGO® Prescribing information GB / NI[External links]

 

References

  1. Johnson M et al. Switching to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/ TDF) maintains HIV-1 virologic suppression through 48 weeks: results of the DRIVE-SHIFT trial. J Acquir Immune Defic Syndr . 2019;81(4):463-472.
  2. Kumar P et al. Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through Week 144 in the DRIVE-SHIFT Trial. J Acquir Immune Defic Syndr. 2021 Feb 17. doi: 10.1097/QAI.0000000000002642. Epub ahead of print.
  3. Orkin et al. Changes in weight and BMI with first-line doravirine – based therapy. AIDS. 2020. 35:91-99.

Supporting documentation

DELSTRIGO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
PIFELTRO® Prescribing Information (Great Britain) & Prescribing Information (Northern Ireland)
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GB-DOR-00204 | Date of Preparation: September 2021