Regimen change associated with weight gain

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According to results of a study presented at IDWeek 2017, an increase in body weight is common in HIV patients who are switched from efavirenz/tenofovir disoproxil fumarate/emtricitabine (EFV/TDF/FTC) to an integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART).

Dr Jamison Norwood, of the Vanderbilt University Medical Centre, in Nashville, explained, “We analysed data from adult patients on EFV/TDF/FTC for ≥2 years with consistent plasma HIV-1 RNA <1000 copies/mL prior to date of switch (or date of sham switch for those who remained on EFV/TDF/FTC).” He noted that HIV-1 RNA levels of <1000 copies/mL were maintained in all patients for at least 18 months after switching therapies.  Norwood added, “We assessed weight change over 18 months in patients switched to an INSTI-containing regimen or a protease inhibitor (PI)-containing regimen versus those remaining on EFV/TDF/FTC over the same period.”

Additionally, the study authors performed a subgroup analysis assessing weight gain seen in patients who switched to dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) compared to patients who switched to regimens containing raltegravir or elvitegravir. Of the 495 patients included in the study, 136 were initiated on an INSTI-containing regimen, 34 were initiated on a PI-containing regimen, and 325 continued therapy with EFV/TDF/FTC.

Norwood reported: “Patients switched to an INSTI-containing regimen gained an average of 2.9kg at 18 months compared to 0.9kg among those continued on EFV/TDF/FTC (P=0.003), while those switched to a PI regimen gained 0.7kg (P=0.81).” Subgroup analysis showed that, of the INSTI-containing regimens, DTG/ABC/3TC was associated with the most amount of weight gain (5.3kg) at 18 months when compared to regimens containing raltegravir or elvitegravir (P=0.19).

Additionally, patients who switched to DTG/ABC/3TC gained significantly more weight than those who continued taking EFV/TDF/FTC (P=0.001). An increase in HbA1c was also seen in patients switched to an INSTI-containing regimen (from 6.4% to 6.9%; P=0.30) but was not significant. The authors further noted that changes in lipid profile were also not significant.

Norwood concluded, “Switching from daily, fixed-dose EFV/TDF/FTC to an INSTI-containing regimen among patients with virologic control was associated with weight gain at 18 months.” The authors called for larger studies to assess changes in cardiometabolic risk factors after switching to an INSTI-containing regimen.

Abstract

Background: Integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) offers persons living with HIV a potent new treatment option. Recently, local HIV clinicians noted weight gain in patients who switched from daily, fixed-dose efavirenz/tenofovir disoproxil fumarate/emtricitabine (EFV/TDF/FTC) to fixed-dose dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). To assess whether regimen switch was significantly associated with weight gain, we evaluated body weight over time among patients with sustained virologic suppression who switched from EFV/TDF/FTC to an INSTI-containing regimen, including DTG/ABC/3TC.

Methods: We analyzed data from adult patients on EFV/TDF/FTC for >=2 years with consistent plasma HIV-1 RNA <1000 copies/mL prior to date of switch (or date of sham switch for those who remained on EFV/TDF/FTC). All maintained HIV-1 RNA <1000 copies/mL for >=18 months post-switch. We assessed weight change over 18 months in patients switched to an INSTI-containing regimen or a protease inhibitor (PI)-containing regimen versus those remaining on EFV/TDF/FTC over the same period. In a sub-group analysis, we compared patients switched to DTG/ABC/3TC versus raltegravir- or elvitegravir-containing regimens. Linear mixed effects models assessed mean differences in weight over time, adjusting for baseline age, sex, race, CD4+ count and weight.

Results: Among 495 patients, 136 switched to an INSTI-containing regimen, 34 switched to a PI-containing regimen, and 325 remained on EFV/TDF/FTC. Patients switched to an INSTI-containing regimen gained an average of 2.9 kilograms (kg) at 18 months compared to 0.9 kg among those continued on EFV/TDF/FTC (p=0.003, Figure a), while those switched to a PI regimen gained 0.7 kg (p=0.81, Figure b). Among INSTI regimens, those switched to DTG/ABC/3TC gained 5.3 kg at 18 months, which was more than raltegravir or elvitegravir regimens (p=0.19, Figure c) and significantly more than those continued on EFV/TDF/FTC (p=0.001, Figure d).

Conclusion: Switching from daily, fixed-dose EFV/TDF/FTC to an INSTI-containing regimen among patients with virologic control was associated with weight gain at 18 months. This weight gain was particularly profound among those switching to DTG/ABC/3TC.

Authors
Jamison Norwood, Megan Turner, Carmen Bofill, Cathy Jenkins, Sally Bebawy, Peter Rebeiro, Todd Hulgan, Stephen Raffanti, David Haas, Timothy R Sterling, John Koethe

MPR material
IDWeek 2017 abstract


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