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• W2334289073 abstract "Telaprevir (TPV) is one of the hepatitis C virus (HCV) NS3/4A serine protease inhibitors recently approved for the treatment of patients with HCV genotype 1 both in naive and pretreated individuals [1,2]. To date, there is only one small phase 2 study on its safety and efficacy in HIV/HCV-coinfected patients naive to HCV therapy, with a proportion of cirrhotic less than 12% [3]. In this study, antiretroviral therapy (ART) was restricted to ATRIPLA or boosted atazanavir along with tenofovir with lamivudine or emtricitabine. Therefore, we lack information on the feasibility of protease inhibitor sparing highly-active antiretroviral therapy (HAART) other than efavirenz or raltegravir (RAL) [3,4]. The aim of present study is to describe the well tolerated coadministration of ETRA-based ART during a full 12-week course of TPV in 44 cirrhotic patients in the ‘real life’ for the first time. This was a multicentre retrospective cohort study conducted in eight hospitals in Spain. From April 2012 to December 2013, all individuals who received HCV triple therapy with TPV together with ETRA-based ART were included in the cohort. Clinical and laboratory data from the first 12 weeks of HCV treatment (the whole duration of triple therapy with TPV) were collected. Forty-four HIV-infected patients with advanced fibrosis or liver cirrhosis started HCV triple therapy with TPV in the eight centres. They received a protease inhibitor sparing HAART regimen containing full-dose ETRA in combination with peginterferon alpha 2a or alpha 2b (peg-IFN) as well as ribavirin (RBV). Table 1 summarizes the most relevant HIV/HCV-related features of the cohort. Fifteen individuals (34%) were on protease inhibitor based HAART, 14 (32%) on nucleoside retrotranscriptase inhibitor (NRTI)-based regimen; 15 (34%) patients were already on ETRA-based ART at the time they started TPV, whereas in the remaining 29 (66%), change to ETRA was performed to avoid drug interactions.Table 1: Baseline characteristics and main 12-week treatment results.Table 1: (Continued) Baseline characteristics and main 12-week treatment results.The majority of patients received peg-IFN-α2a (n = 34, 80%) and 100% of individuals started weight-adjusted RBV. Median baseline HCV-RNA was 6.2 log10 IU/ml (5.2–7). Forty-two individuals completed 12 weeks of triple therapy (one individual withdrew at 6 weeks due to intolerance and one at week 8 due to breakthrough). Three individuals stopped anti-HCV therapy at week 12, two following futility rules and one due to intolerance of the HCV treatment. Thirty-eight patients (86%) achieved negative HCV-RNA and one individual had HCV-RNA lower limit detection (15 UI/ml) at week 12. The Peg-IFN dose was not adjusted in any individual; RBV dose was adjusted in 22 (50%) at week 12. Fourteen percent of the individuals received granulocyte colony stimulating factor; erythropoietin (EPO) and/or blood transfusions were required in 11 patients (25%). Haematological adverse events were the most frequently collected and caused the withdrawn of the HCV therapy in one patient. Two mild hydropic decompensations (ascites) occurred during triple therapy period not requiring discontinuation of HCV or HIV therapy. There were not severe skin reactions or grade 4 anaemia cases. These data support the coadministration of ETRA-based HAART in cirrhotic patients on HCV triple therapy with TPV. The pharmacokinetic interaction between etravirine and telaprevir was studied in a cross trial in healthy volunteers and resulted in lower telaprevir exposure but not to a clinically relevant extent; etravirine exposure was not affected by telaprevir [5]. In our series, ETRA was combined with other drugs with known advantageous pharmacokinetic profiles, such as NRTIs and, more interestingly, RAL or maraviroc. Three quarters of patients were nonnaive to HCV therapy, and 88% achieved negative HCV-RNA at week 12 of therapy. Surprisingly, these results are not lower than those reported among naive individuals [3], with the limitation that we still lack SVR outcomes. The rates of haematological toxicity, RBV adjustments and EPO use were high, as expected, and similar to those reported in cirrhotic HCV-monoinfected patients with cirrhosis receiving triple therapy in the clinical setting [6]. The rates of any grade of skin reactions were significantly lower than expected in clinical trials [1–3]. We have recently reported the successful use of RAL-based HAART in cirrhotic HIV/HCV-coinfected patients receiving TPV [4], but some patients, especially those heavily pretreated and with limited combinations when HIV protease inhibitors are contraindicated, may need a more potent and less prone to resistance antiretroviral regimen than cannot rely solely on RAL along with two NRTIs. In our cohort, 22% of patients received a HAART regimen including at least RAL along with ETRA. All individuals received full-dose ETRA, as no dose adjustment appears to be necessary in patients with hepatic impairment [7,8]. In conclusion, HAART therapies including ETRA were well tolerated in HIV/HCV-cirrhotic patients receiving peg-IFN/RBV along with TPV, with no safety issues and a 12-week rate of negative HCV RNA of 88%. Acknowledgements Conflicts of interest There are no conflicts of interest." @default.
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• W2334289073 date "2014-10-23" @default.
• W2334289073 modified "2023-10-18" @default.
• W2334289073 title "Etravirine-based antiretroviral therapy in HIV/hepatitis C virus coinfected advanced fibrosis patients receiving triple therapy against hepatitis C virus with telaprevir" @default.
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