Background For novel direct acting antiviral (DAA) drugs, HIV/HCV patients have achieved similar sustained virologic response rates as HCV monoinfected patients, but experience in safety and drug interactions with antiretroviral (ARV) regimens is limited in clinical practice, especially in cirrhotic patients.

Purpose We evaluated the safety of DAA and ARV drugs in HCV patients co-infected with HIV-1 treated at the hospital from January to September 2015.

Material and methods HCV/HIV patients on stable ARV regimens were enrolled and received HCV-AAD treatments sofosbuvir/ledipasvir (SOF/LDV), ombitasvir/paritaprevir/ritonavir plus dasabuvir (OTV/PTV/r+DSV) and sofosbuvir plus daclatasvir, simeprevir or ribavirine for at least 4 weeks. Patients with compensated cirrhosis were eligible. All requests for HCV treatment initiation were validated by a pharmacist with a checklist designed for this purpose, taking into account drug interactions and adequacy of recommendations. Safety evaluation was the primary endpoint and included frequency and severity of adverse events (AEs) and standard laboratory parameter monitoring in addition to enhanced renal toxicity monitoring reported in the clinical history. CD4 count and HIV-1 RNA levels were measured to detect HIV virologic rebound.

Results 22 patients were enrolled; 86% had cirrhosis and 86% had not had prior HCV treatment. 76% were treated with SOF/LDV, 9% OTV/PTV/R+DSV and 18% other treatments. 41% were genotype (GT) 1a, 23% GT1b, 4% GT2, 14% GT3 and 23% GT4. 86% were male, 96% were white and mean age was 51 (range 41–59) years. Mean baseline HCV RNA was 6.28 log₁₀ IU/mL (range 5.9–7.0), mean baseline CD4 count was 326 cells/uL (IQR=267) and 68% completed 12–24 weeks of treatment while 32% are currently on treatment. 96% of patients achieved undetectable HVC viral load at week 4. Patients were taking NRTIs (TDF/FTC 41%; ABC/3TC 45%) integrase inhibitor (RAL or DTG) (58%), IPs (DRV or ATV) (29%) or NNRTIs (RPV, ETV, NVP) (13%). One patient had confirmed HIV virologic rebound (HIV-1-RNA ≥400 copies/mL), possibly related to DTG drug intolerance. No patient discontinued HCV treatment due to an AE. AEs occurring in ≥10% of patients were headache (32%), fatigue (25%) and nausea (13%). No significant laboratory abnormalities were observed.

Conclusion In our study, concomitant administration of oral HCV-DAA and habitual ARV drugs were safe and well tolerated, including those patients with cirrhosis. This study will continue because more patients are needed to confirm these results.

No conflict of interest.