Early Emergence of Opportunistic Infections After Starting Direct-acting Antiviral Drugs in HIV/HCV-coinfected Patients

Juan Macías; Francisco Téllez; Antonio Rivero-Juárez; Rosario Palacios; Luis E. Morano; Dolores Merino; Antonio Collado; Lucio García-Fraile; Mohamed Omar; Juan A. Pineda; On behalf of the HEPAVIR, GEHEP and RIS-HEP07 study groups

Disclosures

J Viral Hepat. 2019;26(1):48-54. 

In This Article

Patients and Methods

Design

This was a retrospective review of the clinical records of individuals included in the HEPAVIR-DAA prospective cohort (clinicaltrials.gov ID: NCT02057003), an open cohort that recruited HIV/HCV-coinfected patients receiving treatment against HCV in infectious diseases units across Spain. All individuals treated with interferon-free DAA regimens recruited in this cohort were included in the study. Patients without anti-HCV treatment were included as control group, provided that they were on stable antiretroviral therapy (ART) for at least 6 months. The period of inclusion for all study patients was August 2014-January 2017.

Study Definitions

Definition of cirrhosis. Patients with a liver biopsy showing cirrhosis with previous liver decompensations or with liver stiffness measurement (FibroScan™, Echosens, Paris) ≥12.5 KPa were classified as individuals with cirrhosis.

Classification of infections. All infections detailed in the clinical records of the patients between the date of starting therapy against HCV with DAA and 12 months after the date of SVR12 were recorded and reviewed by the caring physician. Every episode of infection was also centrally reviewed. Whenever necessary, clarification on the reported events was asked directly to the unit and physician following the patient who suffered the event. Infections were subdivided into immunodepression-related infections and other infections. We considered immunodepression-related infections as those observed predominantly or exclusively among immunocompromised hosts.

Follow-up

Patients were prospectively evaluated at the date of starting DAA therapy and at least week 4 and 12 of treatment. After the scheduled end of therapy, patients were evaluated at week 12 post-treatment. The period of observation between SVR12 and 12 months afterwards was retrospectively reviewed using clinical records. HIV-infected patients were followed up at least every 24 weeks at the participating units. SVR12 was defined as undetectable plasma HCV RNA 12 weeks after the scheduled end of therapy.

Statistical Analysis

The incidence of infections was calculated for the study period. The baseline date was the date starting DAA therapy, and the end of follow-up was 12 months after SVR12. For controls, the baseline date was the first visit within the period of inclusion and the end of follow-up was 15 months afterwards, in order to match the period of observation of DAA-treated patients. The incidence of immunodepression-related infections was also calculated. Comparisons were performed applying the Mann-Whitney U test for continuous variables and the chi-square, or Fisher's test when necessary, for categorical variables. The incidence rate of patients treated with DAAs and controls was compared using the STATA stir command. Data were analysed using IBM SPSS 23.0 version (IBM Corporation, Somers, NY, USA) and STATA 9.0 (StataCorp LP, College Station, TX, USA).

Ethics

The study was carried out according to the Helsinki Declaration and was approved by the local Ethics Committee. All patients gave their written informed consent to participate in the study cohort.

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