Table 1.

Phase 2 Studies of HCV Protease Inhibitors in Coinfected Patients

	Telaprevir	Boceprevir
HCV treatment population	Naive Genotype 1	Naive Genotype 1
HIV treatment population	CD4 ≥500a cells/mm3; CD4 ≥300b cells/mm3 HIV RNA ≤100,000a copies/mL; ≤50b copies/mL	CD4 ≥200 cells/mm3 HIV RNA ≤50 copies/mL
Antiretroviral therapy	EFV + TDF/FTC ATV/r + TDF/FTC	No NNRTIs All other drugs permitted
HCV regimen	TLV 750 mg every 8 hours or 1125 mg every 8 hours (if EFV was coadministered) + PEG-IFN alfa-2a 180 μg/wk + RBV 800 mg/dayc	BOC 800 mg every 8 hours + PEG-IFN alfa-2b (1.5 μg · kg−1 · day−1) + weight-based RBV (600–1400 mg/day)
Lead-in phase	No	Yes
Duration of PI treatment (wk)	12	44
Duration of PR treatment (wk)	48	48
Response-guided therapy	No	No
Virologic futility rules	Wk 4 or 8 HCV RNA ≥1000 IU/mL Week 12 ≥1000 IU/mLd Week 12 ≤2 log10 declinee Week 24 detectable HCV RNA	Week 12 ≤2 log10 decline Week 24 detectable HCV RNA
HCV PI PK measured	Yes	Yes
ART PK measured	Yes	No

ATV/r, atazanavir boosted with low-dose ritonavir; BOC, boceprevir; EFV, efavirenz; FTC, emtricitabine; NNRTI, non-nucleoside reverse transcriptase inhibitor (ie, EFV); PR, PEG-IFN plus ribavirin; PK, pharmacokinetics; TDF, tenofovir; TLV, telaprevir.

^aStudy arm of patients not requiring antiretrovirals.

^bStudy arm of patients on select antiretrovirals.

^cFive patients received weight-based ribavirin dosing.

^dIn those patients with week 4 or 8 HCV RNA ≥1000 IU/mL.

^eIn all other patients.