Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 May 17;12(5):e0177402.
doi: 10.1371/journal.pone.0177402. eCollection 2017.

Access and response to direct antiviral agents (DAA) in HIV-HCV co-infected patients in Italy: Data from the Icona cohort

Antonella d'Arminio Monforte  1 , Alessandro Cozzi-Lepri  2 , Francesca Ceccherini-Silberstein  3 , Andrea De Luca  4 , Sergio Lo Caputo  5 , Antonella Castagna  6 , Cristina Mussini  7 , Antonella Cingolani  8 , Alessandro Tavelli  9 , Milensu Shanyinde  2 , Andrea Gori  10 , Enrico Girardi  11 , Massimo Andreoni  12 , Andrea Antinori  13 , Massimo Puoti  14 ; Icona Foundation and HepaIcona Study Group
Affiliations

Access and response to direct antiviral agents (DAA) in HIV-HCV co-infected patients in Italy: Data from the Icona cohort

Antonella d'Arminio Monforte et al. PLoS One. .

Abstract

Background: Real-life data on access and response to direct antiviral agents (DAA) in HIV-HCV coinfected individuals are lacking.

Methods: HCV viremic, HIV-positive patients from Icona and Hepaicona cohorts naïve to DAA by January 2013 were included. Access and predictors of starting DAA were evaluated. Switches of antiretroviral drugs at starting DAA were described. We calculated sustained virological response (SVR12) in those reaching 12 weeks after end-of-treatment (EOT), and defined treatment failure (TF) as discontinuation of DAA before EOT or non-SVR12. Statistical analyses included Kaplan-Meier curves, univariable and multivariable analyses evaluating predictors of access to DAA and of treatment outcome (non-SVR and TF).

Results: 2,607 patients included. During a median follow-up of 38 (IQR:30-41) months, 920 (35.3%) patients started DAA. Eligibility for reimbursement was the strongest predictor to access to treatment: 761/1,090 (69.8%) eligible and 159/1,517 (10.5%) non-eligible to DAA reimbursement. Older age, HIV-RNA≤50 copies/mL were associated to faster DAA initiation, higher CD4 count and HCV-genotype 3 with delayed DAA initiation in those eligible to DAA reimbursement. Up to 28% of patients (36% of those on ritonavir-boosted protease inhibitors, PI/r) underwent antiretroviral (ART) modification at DAA initiation. 545/595 (91.6%) patients reaching EOT achieved SVR12. Overall, TF occurred in 61/606 patients (10.1%), with 11 discontinuing DAA before EOT. Suboptimal DAA was the only independent predictor of both non-SVR12 (AHR 2.52, 95%CI:1.24-5.12) and TF (AHR: 2.19; 95%CI:1.13-4.22).

Conclusions: Only 35.3% had access to HCV treatment. Despite excellent rates of SVR12 rates (91.6%), only 21% (545/2,607) of our HIV-HCV co-infected patients are cured.

PubMed Disclaimer

Conflict of interest statement

Competing Interests: We declare that the funders of the ICONA Foundation had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. None of the authors received any specific funding for this work. Other conflicts of interest: Antonella d'Arminio Monforte reports grants and personal fees from Gilead Sciences, personal fees from Janssen, grants and personal fees from ViiV Healthcare, grants and personal fees from Merck Sharp and Dohme, personal fees from Bristol-Myers Squibb, outside the submitted work; Alessandro Cozzi-Lepri has nothing to disclose; Francesca Ceccherini-Silberstein has nothing to disclose; Andrea De Luca reports grants and personal fees from Gilead Sciences, grants, personal fees and other from ViiV Healthcare, grants and personal fees from Merck Sharp and Dohme, personal fees from Abbvie, personal fees from Janssen, personal fees and other from Bristol-Myers Squibb, outside the submitted work; Sergio Lo Caputo reports personal fees from Gilead Sciences, personal fees from Merck Sharp and Dohme, personal fees from Bristol-Myers Squibb, personal fees from ViiV Healthcare, personal fees from Abbvie, personal fees from Janssen, outside the submitted work; Antonella Castagna reports personal fees from ViiV Healthcare, personal fees from Janssen-Cilag, personal fees from Merck Sharp and Dohme, personal fees from Gilead Sciences, outside the submitted work; Cristina Mussini has nothing to disclose; Antonella Cingolani has nothing to disclose; Alessandro Tavelli has nothing to disclose; Milensu Shanyinde has nothing to disclose; Andrea Gori reports grants and personal fees from Gilead Sciences, grants and personal fees from Bristol-Myers Squibb, grants and personal fees from ViiV Healthcare, grants and personal fees from Janssen-Cilag, grants and personal fees from Merck Sharp and Dohme, outside the submitted work; Enrico Girardi reports personal fees from Otsuka Novel Products, personal fees from Gilead Sciences, personal fees from Janssen, personal fees from Angelini, grants from Gilead Sciences, outside the submitted work; Massimo Andreoni has nothing to disclose. Andrea Antinori reports grants, personal fees and non-financial support from Gilead Sciences, grants, personal fees and non-financial support from Bristol-Myers Squibb, grants, personal fees and non-financial support from ViiV Healthcare, grants and personal fees from Janssen-Cilag, personal fees from Merck Sharp and Dohme, personal fees and non-financial support from Abbvie, outside the submitted work; Massimo Puoti reports grants, personal fees and non-financial support from Gilead Sciences, grants, personal fees and non-financial support from Abbvie, personal fees from Merck Sharp and Dohme, personal fees from Roche, personal fees from Bristol-Myers Squibb, personal fees from Janssen, outside the submitted work.

Figures

Fig 1
Fig 1. Kaplan-Meier estimate of the rate of access to DAA treatment.
(A) From Baseline. (B) From June 2015.
Fig 2
Fig 2. Distribution of DAA regimens by HCV genotype.
2D (ombitasvir,paritaprevir,ritonavir); 3D (ombitasvir,paritaprevir,ritonavir,dasabuvir);BOC (boceprevir);DCL (daclatasvir);LDV/SOF (ledipasvir,sofosbuvir);PR (peg-interferon,ribavirin);RBV (ribavirin);SIM (simeprevir);SOF (sofosbuvir);TLP (telaprevir).
Fig 3
Fig 3. Response to DAA according to different conditions.
(A) Prevalence of SVR12. (B) Prevalence of DAA success.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, et al. Peginterferon alfa-2b or alfa-2° with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580–93. doi: 10.1056/NEJMoa0808010 - DOI - PubMed
    1. Hézode C, Fontaine H, Dorival C, Zoulim F, Larrey D, Canva V, et al. Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis. Gastroenterology. 2014;147(1):132–42 e4. doi: 10.1053/j.gastro.2014.03.051 - DOI - PubMed
    1. Sulkowski M, Pol S, Mallolas J, Fainboim H, Cooper C, Slim J, et al. Boceprevir versus placebo with pegylated interferon alfa-2b and ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a randomised, double-blind, controlled phase 2 trial. Lancet Infect Dis. 2013; 13(7):597–605. doi: 10.1016/S1473-3099(13)70149-X - DOI - PubMed
    1. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, et al. Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection. N Engl J Med. 2013; 368(20):1878–1887 doi: 10.1056/NEJMoa1214853 - DOI - PubMed
    1. Molina JM, Orkin C, Iser DM, Zamora FX, Nelson M, Stephan C, et al. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open- label, non-randomised, phase 3 study. Lancet. 2015; 385(9973):1098–106. doi: 10.1016/S0140-6736(14)62483-1 - DOI - PubMed

MeSH terms

Substances