Efficacy, safety, and patient acceptability of elvitegravir/cobicistat/emtricitabine/tenofovir in the treatment of HIV/AIDS

Figures & data

Table 1 DHHS recommendations on preferred and alternative regimen for first-line antiretroviral therapy⁵

Recommended regimen options

INSTI-based regimens:

• DTG/ABC/3TC only for patients who are HLA-B*5701 negative (AI)

• DTG plus TDF/FTC (AI)

• EVG/c/TDF/FTC only for patients with pretreatment estimated CrCl ≥70 mL/min (AI)

• RAL plus TDF/FTC (AI)

PI-based regimens:

• DRV/r plus TDF/FTC (AI)

Alternative regimen options

NNRTI-based regimens:

• EFV/TDF/FTC (BI)

• RPV/TDF/FTC only if pretreatment HIV RNA <100,000 copies/mL and CD4 cell >200 cells/mm^3 (BI)

PI-based regimens:

• ATV/c plus TDF/FTC only for patients with pretreatment estimated CrCl ≥70 mL/min (BI)

• ATV/r plus TDF/FTC (BI)

• (DRV/c or DRV/r) plus ABC/3TC only if HLA-B*5701 negative (BIII for DRV/c and BII for DRV/r)

• DRV/c plus TDF/FTC only if pretreatment estimated CrCl ≥70 mL/min (BII for DRV/c and BII for DRV/r)

Notes: Evidence rating is either ‘A’ for strong recommendation, or ‘B’ for moderate recommendation. Quality of evidence classified as ‘I’ being one or more randomized trials with clinical outcomes and/or validated, ‘II’ being one or more well-designed, non-randomized trials or observational cohort studies with long-term clinical outcomes, and ‘III’ being expert opinion.

* Indicate allelic variants.

Abbreviations: DHHS, US Department of Health and Human Services; INSTI, integrase strand transfer inhibitor; DTG, dolutegravir; ABC/3TC, abacavir/lamivudine; TDF/FTC, tenofovir/emtricitabine; EVG/c, elvitegravir/cobicistat; RAL, raltegravir; ClCr, creatinine clearance; PI, protease inhibitors; DRV/r, darunavir/ritonavir; EFV, efavirenz; RPV, rilpilvirine; ATV/c, atazanavir/cobicistat; ATV/r, atazanavir/ritonavir; DRV/c, darunavir/cobicistat.

Table 2 Most common adverse events reported in registration trials

	102-Study (n=348)		103-Study (n=353)
	Week 96	Week 144	Week 96	Week 144
AEs (all grades) (%) reported in ≥10% of patients
Diarrhea	25	26	25	22
Nausea	22	23	21	22
Upper respiratory tract infection	21	26	20	24
Headache	16	18	17	18
Nasopharyngitis	10	11	10	14
Depression	12	15	10	12
Fatigue	13	15	15	17
Bronchitis	8	11	10	13
Sinusitis	9	11	7	8
Cough	7	10	8	10
Rash	7	9	9	8
AEs (%) leading to study drug discontinuation in >1 patient
Renal events	2.0	2.2	0.8	1.4
Hepatitis C virus			0.3	0.6
Diarrhea			0.6	0.6
Pyrexia			0.6	0.6
Fatigue	0.3	0.3	0.3	0.3
Depression	0.3	0.3
Nausea			0.3	0.3
Vomiting			0.3	0.3

Abbreviation: AEs, adverse events.

Table 3 Questions included in the treatment ease questionnaire

Treatment ease questions (HIV treatment satisfaction questionnaire)
Score per question −3 (much less satisfied) to 3 (much more satisfied) Treatment ease score range −15 to 15
1. How convenient have you been finding your treatment to be recently?
2. How satisfied are you with the demands made by your current treatment?
3. How satisfied are you with the extent to which the treatment fits in with your lifestyle?
4. How flexible have you been finding your treatment to be recently?
5. How satisfied are you with your understanding of your HIV?

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents (Downloaded from http://aidsinfo.nih.gov/guidelines on 4/15/2015). Available from: http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdfAccessed July 31, 2015

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