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)

Study group = delayed switch group (n=209)

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

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

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

View other MSD HIV products...

Related content

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)
By clicking the links above you will leave the MSD Connect website and be taken to the emc PI portal website

GB-DOR-00204 | Date of Preparation: September 2021