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Effect of HCV Genotype-1 Subtype on Response to Faldaprevir Plus Pegylated Interferon alpha-2A and Ribavirin in Treatment-Naive Patients: Pooled Data From Phase III Trials [Meeting Abstract]

Jacobson, Ira M; Jensen, Donald M; Dieterich, Douglas T; Sarrazin, Christoph; Foster, Graham; Yoshida, Eric M; Nelson, Mark; Ingiliz, Patrick; Soriano, Vicente; Cooper, Curtis; Stern, Jerry O; Quinson, Anne-Marie; Kukolj, George; Scherer, Joseph; Drulak, Murray; Gallivan, John-Paul; Schobelock, Michael; Ferenci, Peter
ISI:000371236404651
ISSN: 1528-0012
CID: 2571262

Comparisons of Populations in Faldaprevir Phase III Studies Based on Pegylated Interferon alpha-2A and Ribavirin-Predicted Responsiveness and Impact on Achieving Svr12 [Meeting Abstract]

Ferenci, Peter; Jensen, Donald M; Dieterich, Douglas T; Jacobson, Ira M; Romero-Gomez, Manuel; Foster, Graham; Asselah, Tarik; Cooper, Curtis; Tural, Cristina; Streinu-Cercel, Adrian; Ryder, Stephen D; Puoti, Massimo; Tam, Edward; Calleja, Jose Luis; Nunez, Marina; Quinson, Anne-Marie; Boecher, Wulf; Voss, Florian; Scherer, Joseph
ISI:000371236404657
ISSN: 1528-0012
CID: 2571272

Interferon-free regimens for hepatitis C: combine and conquer

Martel-Laferriere, Valerie; Bichoupan, Kian; Dieterich, Douglas T
Since the approval of the first direct-acting antiviral agents (DAAs), treatment for hepatitis C virus (HCV) has undergone significant transformation. A new milestone in the treatment of HCV, the approval of the first interferon-free regimens, could be achieved by the end of 2013. For patients with HCV who have absolute or relative contraindications to pegylated-interferon or have failed the currently available treatments, the arrival of new regimens will have a major impact on long-term outcomes. The combinations of DAAs in trials are numerous, and many have demonstrated sustained virologic response rates higher than 90 %. These improvements have also been observed in previous null responders and patients who failed telaprevir- or boceprevir-based regimens. Some specific subpopulations may not be perfectly served by interferon-free regimens, such as patients with genotypes 1a or 3 or cirrhosis, whereas others, such as HIV-infected patients or transplant patients, will definitively benefit from regimens with a lower burden of side effects. This paper reviews the interferon-free regimens currently in phase II or III for which sustained virologic response data are available and discusses the successes and potential pitfalls of these regimens.
PMID: 24170615
ISSN: 1173-8804
CID: 897172

Clinical factors that predict noncirrhotic portal hypertension in HIV-infected patients: a proposed diagnostic algorithm

Parikh, Neil D; Martel-Laferriere, Valerie; Kushner, Tatyana; Childs, Kate; Vachon, Marie-Louise; Dronamraju, Deepti; Taylor, Chris; Fiel, Maria-Isabel; Schiano, Thomas; Nelson, Mark; Agarwal, Kosh; Dieterich, Douglas T
Noncirrhotic portal hypertension (NCPH) is a rare but important clinical entity in human immunodeficiency virus (HIV) populations. The purpose of this study was to describe the clinical factors associated with the condition in an effort to formulate a diagnostic algorithm for easy and early diagnosis. We performed a multicenter, retrospective case-control study of 34 patients with NCPH and 68 control HIV patients. The study found that thrombocytopenia, splenomegaly, didanosine use, elevated aminotransferases, and an elevated alkaline phosphatase level were all significantly more prevalent in the NCPH cohort. Using these easily available clinical parameters, we developed an algorithm for early diagnosis of NCPH in HIV.
PMID: 23911709
ISSN: 0022-1899
CID: 897122

Telaprevir in the treatment of acute hepatitis C virus infection in HIV-infected men

Fierer, Daniel S; Dieterich, Douglas T; Mullen, Michael P; Branch, Andrea D; Uriel, Alison J; Carriero, Damaris C; van Seggelen, Wouter O; Hijdra, Rosanne M; Cassagnol, David G
BACKGROUND: There is an international epidemic of hepatitis C virus (HCV) infection among human immunodeficiency virus (HIV)-infected men who have sex with men. Sustained virologic response (SVR) rates with pegylated interferon and ribavirin treatment are higher in these men during acute HCV than during chronic HCV, but treatment is still lengthy and SVR rates are suboptimal. METHODS: We performed a pilot study of combination therapy with telaprevir, pegylated interferon, and ribavirin in acute genotype 1 HCV infection in HIV-infected men. Men who were treated prior to the availability of, or ineligible for, telaprevir were the comparator group. The primary endpoint was SVR12, defined as an HCV viral load <5 IU/mL at least 12 weeks after completing treatment. RESULTS: In the telaprevir group, 84% (16/19) of men achieved SVR12 vs 63% (30/48) in the comparator group. Among men with SVR, median time to undetectable viral load was week 2 in the telaprevir group vs week 4 in the comparator group, and 94% vs 53% had undetectable viral loads at week 4. Most patients (81%) who achieved SVR in the telaprevir group received
PMCID:3935497
PMID: 24336914
ISSN: 1058-4838
CID: 897202

HIV/hepatitis C virus-coinfected patients and cirrhosis: how to diagnose it and what to do next?

Martel-Laferriere, Valerie; Wong, Michael; Dieterich, Douglas T
Liver disease, specifically cirrhosis, is a leading cause of morbidity and mortality in human immunodeficiency virus (HIV)-infected patients. The diagnosis of early cirrhosis in HIV/hepatitis C virus (HCV)-coinfected patients may be challenging. The development of noninvasive methods for fibrosis assessment empowers the infectious disease specialist to diagnose advanced fibrosis or cirrhosis. Early diagnosis is essential to enroll patients in screening programs for esophageal varices and hepatocellular carcinoma. Cirrhosis may also modify decisions about treatment of both HIV and HCV, including vaccination, medications chosen, and referral for liver transplant.
PMID: 24178247
ISSN: 1058-4838
CID: 897192

Hepatitis C screening beyond CDC guidelines in an Egyptian immigrant community

Perumalswami, Ponni V; DeWolfe Miller, F; Orabee, Hesham; Regab, Amgad; Adams, Mohamed; Kapelusznik, Luciano; Aljibawi, Faozia; Pagano, William; Tong, Virginia; Dieterich, Douglas T
BACKGROUND & AIMS: Many Egyptian-born persons in the U.S. are at high risk of chronic hepatitis C virus (HCV) infection, yet are not aware of their infection and lack healthcare coverage or linkage to care. In this study, we target Egyptian-born persons living in the New York City area for screening and link to care. METHODS: A unique partnership, the Hepatitis Outreach Network (HONE), combines the expertise and resources of the Mount Sinai School of Medicine, the NYC Department of Health and Mental Hygiene and community-based organizations, to provide education, screening and link to care in communities with high prevalence of chronic viral hepatitis. RESULTS: Through four community-based screening events, 192 Egyptian-born persons were screened for HCV. Thirty (15.6%) persons were HCV positive. HCV antibody prevalence in those, whose national origin was Egypt, increased strongly with age and was associated with increasing number of years resident in Egypt and rural residents. Of the 30 Egyptian persons with HCV infection, 18 (60%) received a medical evaluation (2 with local providers and 16 at Mount Sinai). Of the HCV-infected persons evaluated, treatment was recommended in four and begun in three (75%). CONCLUSION: Egyptian-born persons living in the New York City area have a high burden of HCV disease. HONE has successfully established targeted HCV screening in Egyptian-born persons through use of several unique elements that effectively link them to care.
PMID: 23890188
ISSN: 1478-3223
CID: 897112

Treating HCV in HIV 2013: on the cusp of change

Martel-Laferriere, Valerie; Dieterich, Douglas T
Treating hepatitis C virus (HCV) in HIV/HCV co-infected patients is a challenge. Even if the benefits of achieving a sustained virological response are clear, the rates achieved with the combination of pegylated-interferon and ribavirin are disappointing. The addition of direct acting antiviral agents (DAAs) to the treatment of hepatitis C is revolutionizing the treatment of HCV in mono-infected patients. Even if there have not been any agents approved for the treatment of co-infected patients, many studies specifically designed for this population are ongoing. This article reviews available data on the use of DAAs in co-infected patients and the challenges associated with these new drugs.
PMID: 24373079
ISSN: 1478-3223
CID: 897212

Hepatitis C direct-acting antiviral agents: changing the paradigm of hepatitis C treatment in HIV-infected patients

Martel-Laferriere, Valerie; Bichoupan, Kian; Dieterich, Douglas T
Hepatitis C virus (HCV)-related liver disease is a major source of mortality in HIV-infected patients. Approximately one third of all patients with HIV are co-infected with HCV. Patients co-infected with HIV/HCV have shown lower rates of sustained virologic response with pegylated-interferon and weight-based ribavirin as well as more rapid progression of fibrosis than those with HCV mono-infection. Several direct-acting antiviral agents (DAAs), developed originally for HCV mono-infection, are being reevaluated for HIV/HCV co-infection. In addition, entirely new DAAs are being developed, including, interferon-free regimens with fewer side effects, allowing novel treatment opportunities for difficult-to-treat patients. In order for HCV DAAs to be successfully used in the HIV/HCV co-infected population several hurdles must be overcome, including adverse event management and drug-drug interactions. The aim of this review is to discuss the results of trials for new HCV therapies being developed for HIV/HCV co-infected patients and the impact of interferon-free regimens on treatment in the future.
PMID: 24172182
ISSN: 0192-0790
CID: 897182

Efficacy of sofosbuvir and simeprevir-based regimens for 304 HCV treatment-experienced patients in a real-life setting; data from the TRIO network [Meeting Abstract]

Bacon, Bruce R; Dieterich, Douglas; Flamm, Steven L; Kowdley, Kris V; Lawitz, Eric; Milligan, Scott; Younossi, Zobair; Tsai, Naoky
ISI:000344483803024
ISSN: 1527-3350
CID: 2729022