Telaprevir or boceprevir in HIV/HCV‐1 co‐infected patients in a real‐life setting. Interim analysis (24 weeks). COINFECOVA‐SEICV study

• Published in: Journal of the International AIDS Society Vol. 17; no. 4 Suppl 3; pp. 19634 - n/a
• Main Authors: Minguez, Carlos, Ortega, Enrique, Flores, Juan, Carmena, Jorge, Masiá, Mar, Montero, Marta, Reus, Sergio, Tornero, Carlos, Jose Galindo, Maria, Garcia‐Deltoro, Miguel, Amador, Concepción, María Cuadrado, Jose, Usó, Jorge, López‐Aldeguer, Jose
• Format: Journal Article
• Language: English
• Published: Switzerland International AIDS Society 01.11.2014; John Wiley & Sons, Inc
• Subjects: Acquired immune deficiency syndrome; AIDS; Antiretroviral agents; Hepatitis C; HIV; Human immunodeficiency virus; Hypertension
• ISSN: 1758-2652; 1758-2652
• DOI: 10.7448/IAS.17.4.19634

Introduction In general, HIV co‐infected patients included in clinical trials evaluating the hepatitis C virus (HCV) therapy with telaprevir (TVR) or boceprevir (BOC) with advanced fibrosis, are scarce. We analyze data concerning the use of these drugs in a real‐life clinical setting with patients affected by a more advanced degree of fibrosis in a Spanish cohort. Methods We evaluated safety and efficacy in an interim analysis encompassing the first 24 weeks of triple therapy with peginterferon (alfa‐2a or alfa‐2b), ribavirin and TVR or BOC in an observational, multicentre study. HIV/HCV genotype 1 co‐infected patients beginning therapy from January 2012 to July 2013 were included. Results Enrolled patients were 155 (144 patients on TVR and 11 on BOC), average age was 47 years, 83% were male. With respect to HCV treatment, 44% were naïve, 13% relapsers, 17% partial responders, 21% null responders, and in seven patients, the previous response was unknown. All but three (98%) were under antiretroviral therapy (ART) (other than reverse transcriptase inhibitors, the backbone was raltegravir 43%, atazanavir 35%, and etravirine 28%). Median HCV‐RNA at baseline was 6.1 log10, 54% were cirrhotic and 38% F3. At week 4, 93% of patients continued on therapy, 81% at w12, and 73% at w24. Virological failure was observed more frequently in: cirrhotic patients (19% [95% CI, 11–27]) vs F3 (12% [CI, 4–20]); patients with TT allele of the IL28B polymorphism (40% [CI, 18–61]) vs CT (21% [CI, 12–31]), or CC (2,2% [CI, −2–6]); previous null responders (37.5% [CI, 21–54]) vs partial responders (15.4% [CI, 1–29]), naïve (13% [CI, 5–21]) or relapsers (0% [CI, 0–0]); and in patients with a genotype subtype 1a (23.6% [CI, 57–76]) vs 1b (8.1% [CI, −1–17]). Overall, 17% had virological failure and in 8% treatment was discontinued due to adverse events. Severe adverse events occurred in 30 patients (19%). Haematologic disorders were the most common type including severe anaemia in 12 (7.7%) patients. Erythropoietin was employed in 41 patients (26.4%) and 11 (7.1%) received blood transfusions. Nineteen patients (12.2%) were treated with G‐CSF, and 17 (11%) with thrombopoietin‐receptor agonists. Five patients died (3.2%), three due to hepatic decompensation, one due to pneumonia and one due to pulmonary hypertension. Conclusions In a real‐life setting, therapy against HCV in co‐infected patients with advanced liver fibrosis shows high virologic success at 24 weeks. However, frequent haematologic disorders are observed and a close monitoring and an intensive therapy are needed to optimize the results.