DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design

* Permitted ART : 3TC/FTC, ABC, TDF, RPV, RAL, MVC

SMV 150 mg : 1 pill qd ; PEG-IFNα-2a : 180 m g SC once weekly
RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or = 75 kg)

• Response-guided therapy : Patients with HCV RNA < 25 IU/ml at W4 and < 15 IU/ml at W12 stopped treatment at W24, otherwise they continued until W48
• Virological stopping rules : SMV discontinued if HCV RNA >1000 IU/ mL at W4 or W12, or if HCV RNA confirmed = 25 IU/ mL at W24 or W36

Objective

• SVR₁₂ (HCV RNA < 25 IU/mL) by intention to treat

Baseline characteristics and patient disposition

SVR₁₂ (HCV RNA < 25 IU/ mL)

Response guided therapy (RGT)

• Patients with HCV RNA < 25 IU/ml at W 4 (undetectable or detectable) and <15 IU/ml at W 12 (undetectable) stopped treatment after W24
• Of the 54 (58%) patients who met RGT, 87% had SVR₁₂

SVR₁₂ (HCV RNA < 25 IU/ mL)

SVR₁₂ (HCV RNA < 25 IU/ mL)

Virologic failure

Emergence of resistance

• Paired baseline and failure NS3 sequencing in 26/29 failure
• Emergence of NS3 mutations in 25/26 (96%)

HIV endpoints

• Confirmed failure : 2/93 (2.2%) of patients on antiretroviral therapy ; both had SVR₁₂

Adverse events

Summary

• Oral, once-daily treatment with SMV 150 mg for 12 weeks plus PEG-IFN + RBV for either 24 or 48 weeks led to high rates of SVR₁₂ in patients with HCV genotype 1 and HIV-1 coinfection , regardless of prior HCV treatment response
• Most eligible patients met response-guided therapy criteria enabling a shorter, 24-week overall duration of PEG-IFN + RBV therapy
• SMV was generally well tolerated, with safety similar to that reported in larger studies in patients without HIV coinfection
• Limitations
  • No control arm