Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection

Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection

The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection

After providing informed consent, patients will undergo to a screening visit. If they meet the inclusion criteria and none of the exclusion will be included in this trial. Patients will take one tablet of Biktarvy at day for 48 weeks. Then the results will be compared with a cohort of 66 patients treated with 2 nucleoside analogues and one integrase chain transfer inhibitor.

Inclusion Criteria:

• Male and female patients aged 18-65 years
• ART naïve
• HIV infection of less than 100 days post-infection (documented 3 month previous negative serology or incomplete WB test with negative p31 band)
• Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner.

Exclusion Criteria:

• Known hypersensitivity to any drug included in Bictegravir/FTC/TAF regimen
• AST >5 times UNL
• Creatinine Clearance <30 mL/min/1.73m2
• Any end-stage organ disease
• Acute or chronic HCV co-infection
• Use of PrEP with Truvada® until 4 weeks before the onset of symptoms of PHI (risk of acquired-drug resistance to FCT or TDF).