Abstract
The renal function is a key-issue in HIV/HCV co-infected patients, nevertheless, it has not established so far whether HCV treatment with new direct acting agents could impact on estimated glomerular filtration rate (eGFR) variations. In the present work, we examined the real-life data on renal function that have been prospectively collected in the SIMIT compassionate-use program of ombitasvir/paritaprevir/ritonavir plus dasabuvir (OBV/PTV/r + DSV) in 144 HIV/HCV genotype 1 co-infected patients. The population was 74% male, 30.5% in CDC stage C, with median age of 52 years (48.0–56.5) and median liver stiffness of 7.8 kPa (6.7–9.2). Median baseline eGFR was 102.0 (90.8–108.1), changing to 99.8 (83.5–104.8) at the end of treatment (EoT), and 100.0 (87.3–105.6) 12 weeks after the EoT (FU12), p<0.0001. No patient had grade 3–4 increase of creatinine. At EoT 60/144 (41.7%) patients had ≥ 5% reduction in their eGFR, confirmed at FU12 in 39/60 (65.0%) cases. Longer duration of HCV infection (cut-off 12.9 years), lower HCV-RNA viral load (cut-off 1,970,160 IU/ml) and lower platelet count (cut-off 167,000 x106/L) were significantly associated with eGFR decline at logistic analysis (adjOR 2.9, 95%CI 1.0–8.8, p = 0.05; adjOR 3.5, 95%CI 1.2–10.4, p = 0.02; adjOR 2.8, 95%CI 1.1–6.8, p = 0.03, respectively). After repeating the analysis throughout a mixed model, a higher eGFR decline was highlighted in patients concomitantly treated with tenofovir (p = 0.0001), ribavirin (p = 0.0001), or integrase inhibitors (p <0.0001), with longer duration of HIV (p = 0.0002) and HCV infection (p = 0.035), lower baseline HCV RNA (p <0.0001), previous HCV treatment (p<0.0001), and older age (p<0.0001). In conclusion, our study confirms a good renal safety profile of OBV/PTV/r + DSV treatment in HIV/HCV patients, and the median decline of 2 ml/min in eGFR, albeit statistically significant, is of doubtful clinical significance. The role of aging, concomitant therapies and duration of HIV/HCV infection needs to be further investigated.
Highlights
New direct-acting antiviral (DAA) agents have radically changed the therapeutic scenario of chronic HCV infection in both mono-infected and HIV co-infected patients [1, 2]
With the aim of analysing the creatinine and estimated glomerular filtration rate (eGFR) trends in a specific population of HIV/ HCV genotype 1 co-infected individuals treated with the same DAA regimen, we examined the data on renal function of the population treated in the SIMIT compassionate-use program of OBV/PTV/r + DSV [5]
A very few cases (2/179 patients) of creatinine clearance decrease to
Summary
New direct-acting antiviral (DAA) agents have radically changed the therapeutic scenario of chronic HCV infection in both mono-infected and HIV co-infected patients [1, 2]. Little is known on the trend of estimated glomerular filtration rate (eGFR) in patients who clear HCV infection during and after treatment with new DAAs, especially in real life settings [10, 11]. A worsening of renal function after DAA treatment has been reported in patients with cirrhosis, and in those treated with OBV/PTV/r + DSV [10]. It has not established so far whether HCV clearance is related or not with an improvement in GFR, or if, on the contrary, the combination of antiretroviral drugs and DAAs can even cause a reduction of GFR, throughout a direct mechanism or indirectly, for drug-drug interactions (DDI)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
