Virologic Response Following Combined Ledipasvir and Sofosbuvir Administration in Patients With HCV Genotype 1 and HIV Co-infection

Osinusi, Anu; Townsend, Kerry; Kohli, Anita; Nelson, Amy; Seamon, Cassie; Meissner, Eric G.; Bon, Dimitra; Silk, Rachel; Gross, Chloe; Price, Angie; Sajadi, Mohammad M.; Sidharthan, Sreetha; Sims, Zayani; Herrmann, Eva; Hogan, John P.; Teferi, Gebeyehu; Talwani, Rohit; Proschan, Michael A.; Jenkins, Veronica; Kleiner, David E.; Wood, Bradford J.; Subramanian, G. Mani; Pang, Phillip S.; McHutchison, John G.; Polis, Michael A.; Fauci, Anthony S.; Masur, Henry; Kottilil, Shyam

doi:10.1001/jama.2015.1373

Cited by 190 publications

(165 citation statements)

References 23 publications

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“…125 The ION-4 study studied 335 treatment-naive and treatment-experienced patients and reported an overall SVR12 of 96%. 126 There are no data of shortened 8-week duration therapy of LDV/SOF in HCV and HIV coinfection.…”

Section: Management Of Hcv In Hiv Coinfectionmentioning

confidence: 99%

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Puri

Saraswat

Dhiman

et al. 2016

Journal of Clinical and Experimental Hepatology

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India contributes significantly to the global burden of HCV. While the nucleoside NS5B inhibitor sofosbuvir became available in the Indian market in March 2015, the other directly acting agents (DAAs), Ledipasvir and Daclatasvir, have only recently become available in the India. The introduction of these DAA in India at a relatively affordable price has led to great optimism about prospects of cure for these patients as not only will they provide higher efficacy, but combination DAAs as all-oral regimen will result in lower side effects than were seen with pegylated interferon alfa and ribavirin therapy. Availability of these newer DAAs has necessitated revision of INASL guidelines for the treatment of HCV published in 2015. Current considerations for the treatment of HCV in India include the poorer response of genotype 3, nonavailability of many of the DAAs recommended by other guidelines and the cost of therapy. The availability of combination DAA therapy has simplified therapy of HCV with decreased reliance of evaluation for monitoring viral kinetics or drug related side effects. ( J CLIN EXP HEPATOL 2016;6:119-145) T here have been revolutionary changes in the management of chronic hepatitis C (CH-C) over the last few years. Pegylated interferon alfa (Peg-IFNa) plus ribavirin (RBV) therapy, which till the recent past was the standard of care, has been eclipsed by the arrival of newer directly acting antiviral agents (DAAs). Not only do the DAAs have better efficacy, they are also associated with lower side effects, have better tolerability, a shorter duration of therapy, and have simpler administration.In the recent guidelines issued by the American Association for the study of Liver Diseases (AASLD), in collaboration with the Infectious Diseases Society of America 1 and the European Association for Study of the Liver z (EASL), 2 the role of Peg-IFNa/RBV therapy in the management of HCV has been relegated to second-line, backup status. These newer guidelines, however, cannot be implemented in India as many of the recommended drugs are yet to be marketed in India. Other considerations for the treatment of HCV in India are a predominance of

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Section: Management Of Hcv In Hiv Coinfectionmentioning

confidence: 99%

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Puri

Saraswat

Dhiman

et al. 2016

Journal of Clinical and Experimental Hepatology

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“…29,32 A summary of baseline patient demographics is shown in Table 1. One HIV/HCVcoinfected patient treated with SOF/LDV for 12 weeks and one HCV-monoinfected patient treated with SOF/LDV/GS-9669 for 6 weeks relapsed within 4 weeks of completing treatment.…”

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…29 Thirty-seven subjects were virally suppressed with ARVs while 13 subjects were not receiving ARVs. 29 Study approved ARVs included emtricitabine/ tenofovir combined with efavirenz, raltegravir, or rilpivirine. Subjects not on ARVs had a stable CD4 T-lymphocyte count ‡500 cells/mm 3 (n = 2) or a stable CD4 count with an HIV viral load <500 copies/ml at baseline (i.e., elite controllers, n = 11).…”

Section: Methodsmentioning

confidence: 99%

“…[5][6][7][8]10 Treatment of chronic HCV infection is now possible with interferon (IFN)-free regimens composed of directly acting antiviral (DAA) agents that directly inhibit viral proteins. 11 Marked advances in IFN-free DAA treatment of HCV infection in HIV/HCV-coinfected subjects have also been reported, 29,30 such that HCV disease will be increasingly eradicated in this population.…”

Section: Introductionmentioning

confidence: 99%

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Interferon-Free Treatment of Hepatitis C Virus in HIV/Hepatitis C Virus-Coinfected Subjects Results in Increased Serum Low-Density Lipoprotein Concentration

Townsend

Meissner

Sidharthan

et al. 2016

AIDS Research and Human Retroviruses

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Chronic hepatitis C virus (HCV) infection is associated with lower serum concentration of low-density lipoprotein (LDL-C), the primary cholesterol metabolite targeted pharmaceutically to modulate cardiovascular risk. Chronic infection with human immunodeficiency virus (HIV) and treatment with antiretrovirals (ARVs) are associated with dyslipidemia and increased risk of cardiovascular disease. In subjects coinfected with HIV and HCV, lipid abnormalities associated with either infection alone are often attenuated. Treatment of chronic HCV infection in HIV/HCV-coinfected subjects is now possible with interferon (IFN)-free regimens composed of directly acting antivirals (DAAs). We previously observed a marked increase in serum LDL-C in HCVmonoinfected subjects treated with sofosbuvir and ribavirin (SOF/RBV) that correlated with viral decline in serum, suggesting a direct influence of HCV clearance on serum cholesterol. In the present study, we assessed longitudinal changes in cholesterol in HIV/HCV-coinfected subjects during treatment of HCV genotype-1 (GT1) infection with combination DAA therapy. We report a rapid increase in LDL-C and LDL particle size by week 2 of treatment that was sustained during and after treatment in HIV/HCV-coinfected subjects. No change in serum LDL-C was observed at day 3 of treatment, in spite of a marked reduction in serum HCV viral load, suggesting LDL-C increases do not directly reflect HCV clearance as measured in peripheral blood. After effective DAA therapy for HCV, an increase in LDL should be anticipated in HIV/HCV-coinfected subjects.

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Hepatitis C and HIV Co-infection

Graham

2015

JAMA

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Virologic Response Following Combined Ledipasvir and Sofosbuvir Administration in Patients With HCV Genotype 1 and HIV Co-infection

Abstract: clinicaltrials.gov Identifier:NCT01878799.

Cited by 190 publications

References 23 publications

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Indian National Association for Study of the Liver (INASL) Guidance for Antiviral Therapy Against HCV Infection: Update 2016

Interferon-Free Treatment of Hepatitis C Virus in HIV/Hepatitis C Virus-Coinfected Subjects Results in Increased Serum Low-Density Lipoprotein Concentration

Hepatitis C and HIV Co-infection

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