November 27, 2013

HCV Infected Prisoners

BMC Infectious Diseases

Should They Be Still Considered a Difficult to Treat Population?

Fabio Iacomi, Giuseppina Iannicelli, Andrea Franceschini, Paolo Migliorisi, Silvia Rosati, Pierluca Piselli, Paola Scognamiglio, Gabriella De Carli, Sonia Marcellini, Fabrizio Palmieri

BMC Infect Dis. 2013;13(374)

Abstract

Background: The prevalence of chronic hepatitis C virus (HCV) infection in the Italian correctional population is estimated to be around 38%. In this setting HCV infection treatment is controversial because of several factors such as active drug substance abuse, psychiatric illness, length of treatment, risk of re-infection, poor adherence and low success rate.

Methods: A retrospective data review of 159 inmates, positive for anti-Hepatitis C virus (HCV) antibody, evaluated to National Institute for Infectious Diseases "L. Spallanzani" (INMI) from January 2006 to December 2009, was conducted to evaluate rate of completion (feasibility) and outcome efficacy of chronic Hepatitis C Virus (HCV) infection treatment with Pegylated Interferon and Ribavirin in five correctional facilities in Rome.

Results: Of the 159 inmates evaluated in the study period, 50, all male (median age 39 years) were treated. Twenty patients (40%) did not complete treatment: 15 showed no response and therapy was stopped, 5 patients (10%) interrupted treatment because of adverse reactions. The global feasibility was 60%. The overall sustained virologic response (SVR) was 50% (32% for genotype 1 and 68% for genotype other than 1). The main predictors of SVR at the Multivariable Logistic Regression Odds Ratio (MLR-OR) were a better pretreatment histological diagnosis (absence of bridging fibrosis or cirrhosis [MLR-OR 11.85; 95% CI 1.96–71.62) and a HCV genotype other than 1 (MLR-OR 5.87; 95% CI 1.49–23.17).

Conclusions: Chronic HCV infection treatment in correctional facilities is feasible and effective and should be strongly recommended, in combination with preventive measures, in appropriately screened patients because it represents an important opportunity to treat a population with a high prevalence of chronic HCV infection among whom treatment options post incarceration may be limited.

Background

In Italy the estimated prevalence of anti-Hepatitis C virus (HCV) antibody seropositivity in the general population is 2,9%,with a north–south gradient and increasing with age.[1,2] Rates are considerably higher in the Italian correctional population (38%) because of the higher proportion of intravenous drug users (IVDUs).[3]

Despite the relatively high success rates reported in the U.S. and Canada correctional population,[4–9] several factors reported as potential obstacles to treatment of chronic HCV infection in the general population, such as active drug substance abuse, psychiatric illness, length of treatment, risk of re-infection, poor adherence and low success rates, may be more prevalent in this setting.[5,8,10]

Many accurate data are published on the prevalence of HCV infection in the correctional population in Europe,[2,11,12] but in the same population few data are available on the outcome of treatment of chronic HCV infection.[12,13]

To evaluate feasibility and efficacy of treatment of chronic HCV infection in this setting, a retrospective review of medical records was performed in a cohort of inmates in five correctional facilities in Rome.

Methods

Patients

Were retrospectively evaluated data of 159 inmates (148 males, 11 females) who tested positive for anti-HCV antibody (HCV-Ab) at their entry in five correctional facilities in Rome (Casa Circondariale(CC) Regina Coeli, and Istituti Penitenziari Rebibbia, which include: CC Nuovo Complesso, CC Femminile, Casa di Reclusione, III Casa, Casa di Reclusione; average daily census 2541 in the study period) and were sent for consultation at the National Institute for Infectious Diseases "L. Spallanzani" (INMI), Rome, from January 2006 to December 2009.

All inmates were tested for HCV-Ab, HCV viremia (HCV-RNA), human immudeficiency virus antibodies (HIV-Ab) and hepatitis B surface antigen (HBsAg). Serologic tests were performed using microparticle enzyme immunoassays (EIAs) for HBsAg (AxSYM, Abbott, Wiesbaden, Germany), HCV 3.0 third-generation EIAs (Abbott) for HCV-Ab and the Genscreen HIV 1/2 ELISA (BioRad, Marnes La Coquette, France) for HIV-Ab. HCV-RNA was measured using the COBAS Taq-Man HCV test (Roche Molecular System) with a detection limit of 12 IU/ml. If patients had HCV-RNA detectable in serum, HCV genotype was determined using the reverse hybridization method (InnoLipa HCV II; Siemens Medical Solutions Diagnostics, Tarrytown, NY), those with an expected length of stay in the correctional facility of less than 12 (for genotypes 2, 3) or 18 (for genotypes 1, 4) months necessary for evaluation, uninterrupted treatment and follow-up were not considered eligible for treatment. The remaining population underwent clinical and laboratory evaluation to assess contraindications to treatment with interferon and ribavirin, including psychiatric consultation and screening for drugs or alcohol abuse: patients were considered eligible for immediate treatment if they were on rehabilitation or stable maintenance agonist therapy (methadone) according recommendations of Italian Association for the Study of the Liver (A.I.S.F.), Italian Society of Infectious and Tropical Diseases (S.I.M.I.T.), Italian Federation Department's Operators and Addiction Services (FederSerD), Italian Prison Medicine and Healthcare Society (S.I.M.S.Pe).[14,15]

For the many inmates who were in the process of being transferred to other correctional facilities depending for health assistance from other institutions outside Rome, or were going to be released and living outside our area, initiation of treatment was deferred and they were referred for treatment and clinical and virological follow-up to other healthcare facilities in the place of final residence.

Information on length of incarceration was available on clinical charts only as categorical variable: for genotypes 1 and 4 < or > of 18 months; for the other genotypes < or> of 12 months.

Figure 1 shows the decisional algorithm for eligibility to treatment.

813105-fig1

Figure 1. Algorithm for evaluation of patients eligible to the treatment.

Patients were offered treatment if they had undergone a liver biopsy at INMI that was consistent with chronic hepatitis and had been categorized as F1 to F4 according to METAVIR system for fibrosis staging.[16]

Standard guidelines for treatment of chronic HCV infection, available at the time of patient's evaluation, were followed.[17]Genotypes 1 and 4 were treated for 48 weeks with Pegylated Interferon-α2a, 180 μcg subcutaneously once a week, in combination with Ribavirin 15 mg/kg/day. Genotypes 2 and 3 were treated for 24 weeks with Pegylated Interferon-α2a, 180 μg subcutaneously once a week in combination with Ribavirin 800 mg/day.

Pegylated Interferon-α2a was administered by directly observed therapy (DOT) while Ribavirin was self administered.

Side effects were regularly monitored and therapy was modified or stopped according to standard guidelines.

In accordance with provisions of the regulatory authority "Agenzia Italiana del Farmaco" (A.I.F.A.) in force at 2008, when we had conducted this study, the approval of the Ethics Committee was not required for retrospective observational studies.[18]

Data Analysis

The measure of feasibility was the rate of treatment completion. The measure of efficacy was the rate of sustained virologic response (SVR), defined as undetectable HCV-RNA in serum at the end of follow-up, 24 weeks after treatment withdrawal. The whole treated population - i.e. all patients who received at least one dose of study medication- was included in the analysis (intention to treat analysis).

Association between SVR and selected patients' characteristics was assessed by means of Odds Ratios (ORs) and their 95% Confidence Intervals (95% CI) in order to define predictors of SVR in the study population using Logistic Regression.

χ2 test (or Fisher's exact test when applicable) or Mann Whitney non-parametric test were used to compare groups for categorical or continuous variables, respectively.

Univariable analysis was conducted to select significant variables (p<0.10) to be included in the multivariable analysis, in which Multivariable Logistic Regression Odds ratio (MLR-OR) was calculated. Were considered two different models: Model I in which all selected variables were included, and Model II in which the final model included only those variables selected after a backward elimination (p<0.10) of those variables included in Model I.

Statistical analysis was performed using SPSS ver. 19 (SPSS Inc).

Results and Discussion

Continue reading full article here …..

Nov 27, 2013, 1:05pm EST

Don Seiffert
BioFlash Editor-Boston Business Journal
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Jay_Luly_Enanta_HIRES-304

Jay Luly, CEO of Enanta Pharmaceuticals, called 2013 a "transformational year."

In its first full-year financial report since becoming a publicly-traded biotech, Enanta Pharmaceuticals reported a smaller loss than expected, and one analyst is raising his estimated chance of success of its drug for hepatitis C.

The Watertown biotech, which raised $64 million (minus fees and other expenses) in its initial public offering in March, reported a net income of $9.6 million for the full year that ended in September, with revenue of $32 million compared to $42 million for the previous year. Adjusted to exclude one-time costs and other expenses, the company had an adjusted net loss per share of 67 cents a share – down from a profit of $1.13 in 2012, but beating the $1.78 consensus that three analysts were expecting for the full year.

The company also said it had $112.2 million in cash at its disposal as of Sept. 3 – enough, it said, to last for the next two years.

But it wasn’t the company’s finances that impressed analysts at Leerink Swann, rather it was Enanta’s prospects for future revenues from a drug it’s developing as part of a treatment being tested by Abbott Laboratories for hepatitis C. The company recently reported positive data from a Phase 3 trial of ABT-450, and Howard Liang of Leerink Swann said in a research note this week that after those results that he’s upping his estimated probability that the drug will ultimately be approved from 85 percent to 90 percent.

“We believe the first Phase III results further de-risk the program,” he wrote. “We continue to see (Enanta) as a de-risked small cap play to participate in what we anticipate to be a large hepatitis C market.”

Liang also cited the possibility for Enanta to exercise an option to get more royalties from Abbott through paying more of the development costs. He raised his price target for the stock from $28 to $29 a share.

Enanta’s stock has shot up by more than 20 percent since the Nov. 19 announcement of the Phase 3 trial results. This morning, it was trading at $25.56 a share at the opening of the markets, up 48 percent since its March 21 IPO.

In a statement, CEO Jay Luly called 2013 a “transformational year for Enanta.”

“Our initial public offering in March further strengthened our cash position, and we ended the year with three (hepatitis C) compounds in the clinic and we have progressed our internal programs and pipeline candidates,” he said.

NIH Statement on World AIDS Day 2013 — December 1, 2013

Embargoed for Release: Wednesday, November 27, 2013, 1 p.m. EST

Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases
Jack Whitescarver, Ph.D., Director, NIH Office of AIDS Research
Francis S. Collins, M.D., Ph.D., NIH Director

In the 25 years that have passed since the first annual commemoration of World AIDS Day, extraordinary scientific progress has been made in the fight against HIV/AIDS. That progress has turned an HIV diagnosis from an almost-certain death sentence to what is now for many, a manageable medical condition and nearly normal lifespan. We have come far, yet not far enough.

In 2012, more than 2 million new HIV infections and 1.6 million AIDS-related deaths occurred globally. Although these numbers represent a decline from previous years, they also reflect a grim reality: far too many people become HIV-infected and die from the effects of the disease. On World AIDS Day, the National Institutes of Health (NIH) reaffirms its commitment to finding improved HIV treatments and tools for preventing infection (including a vaccine), addressing the conditions and diseases associated with long-term HIV infection, and, ultimately, finding a cure.

Over the years since HIV was established as the cause of AIDS, NIH-funded researchers—in partnership with academia and the biotechnology and pharmaceutical industries—have developed more than 30 life-saving antiretroviral drugs and drug combinations for treating HIV infection. Moreover, as the landmark HPTN 052 clinical trial proved, antiretroviral treatment can also effectively prevent HIV transmission by lowering the amount of virus in infected individuals, thereby making them less able to transmit the virus to their sexual partners. Today, we are working to improve upon these medicines by developing drugs that are longer-acting, simpler to use, and with fewer side effects. Further, NIH scientists and grantees are exploring the administration of anti-HIV antibodies as a way to treat infection. This approach was recently shown to be effective when used in monkeys infected with a genetically engineered version of simian HIV.  Additionally, NIH researchers have begun early stage human testing of a monoclonal antibody (called VRC01), which in the laboratory, protected human cells against infection by more than 90 percent of known HIV strains.

However, advances in antiretroviral therapy or the discovery of new treatments are of little value if HIV-infected individuals do not know they are infected, do not have adequate access to HIV treatment and the necessary medical care to control their virus levels, or do not adhere to their treatment regimen. For example, of the 1.1 million people living with HIV infection in the United States, only 25 percent receive ongoing medical care and have virus levels that are adequately controlled by taking antiretroviral medications as prescribed. The NIH is funding studies in the United States and internationally to explore new approaches to addressing this problem. The HPTN 065 study (also known as TLC-Plus), is assessing the feasibility of conducting widespread voluntary HIV testing, linking HIV-infected individuals to care and antiretroviral treatment, and providing incentives to individuals to adhere to treatment. The study is being conducted in New York City, and Washington, D.C.—both of which have communities at greater than average risk of HIV infection. Internationally, the recently launched HPTN 071 study, also called PopART, is examining whether offering expanded voluntary HIV testing along with enhanced delivery of antiretroviral treatment and prevention services can substantially reduce the number of new infections in South Africa and Zambia. The study will involve 21 communities and 1.2 million people in those countries. 

NIH-funded research has proven the effectiveness of such HIV prevention strategies as voluntary medical adult male circumcision and pre-exposure prophylaxis, or PrEP (taking a daily antiretroviral pill to prevent HIV acquisition). In order to be effective, these strategies must be used consistently under strict guidelines. NIH supports behavioral and social science research designed to better understand how to foster adherence to medications, promote acceptance and overcome barriers to the use of effective HIV prevention tools.

The NIH also continues to investigate new HIV prevention tools for those groups most at risk for HIV infection, including women and men who have sex with men. The multinational ASPIRE clinical trial, launched in 2012, is testing whether a vaginal ring containing the experimental antiretroviral drug dapivirine can prevent HIV infection in women. The recently launched MTN 017 clinical trial is examining the safety of a rectally applied gel containing the antiretroviral drug tenofovir for men who have sex with men.

A cornerstone of our HIV prevention efforts continues to be the search for a safe and effective vaccine. The pathway to an effective HIV vaccine has been challenging and marked by disappointments; however, basic research advances this year are charting the course for a new generation of investigational HIV vaccines. Through the work of NIH scientists and grantees, we have gained insights into how HIV and a strong antibody response to the virus co-evolve in an infected person and improved our understanding of how B-cells create potentially protective immune system responses. Further, NIH-funded researchers have developed a new tool for identifying broadly neutralizing antibodies against HIV that could help speed vaccine research and illuminated in exquisite detail the protein largely responsible for enabling HIV to enter human immune cells and cause infection.

Additionally, ongoing analyses of the landmark RV 144 HIV vaccine trial conducted in Thailand are providing important information about human immune responses and other factors that may explain why the investigational vaccine regimen reduced the risk of HIV acquisition by 31 percent. Large-scale investigational clinical trials to build on the RV 144 results are being planned for South Africa and Thailand.

We have reached the point when the thought of an HIV cure is not unrealistic. Several cases, including that of a toddler, have demonstrated the possibility of sustained remission, in which patients control or perhaps even eliminate HIV without the need for a lifetime of daily antiretroviral therapy. NIH continues to focus on the important area of research toward a cure through basic science and clinical testing that is underway or in development.

On this World AIDS Day, we take stock of what has been achieved and look forward to what can be accomplished in the near future toward the universally shared goal of ending the HIV/AIDS pandemic.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od/.

The Office of AIDS Research, part of the Office of the Director, plans and coordinates the scientific, budgetary, legislative and policy elements of the NIH AIDS research program. Additional information, including the trans-NIH strategic plan and budget, is available at http://www.oar.nih.gov/.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visitwww.nih.gov.

NIH...Turning Discovery Into Health®

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Bernie Miller: My Journey with Hepatitis C

Bernie Miller

November 26, 2013

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My name is Bernie Miller. I celebrated my 60th birthday this week. Let me begin by telling you some of my past. I was born in Arkansas but moved to California with my family in 1960 at the age of 6. I grew up in the San Francisco Bay Area in the 60's. As a lot of young people did in those years, I experimented with alcohol and drugs. When I was 18, I started working in bars. At that point, alcohol became my favorite mind altering substance. Back then drinking on the job was not only accepted, but expected of bartenders. I did not let down anyone's expectations in that regard. I also learned that using crank (the drug to go fast before the modern day methamphetamine) would help me to stay awake and be able to drink longer. By the time I was 30, I had done enough damage to my liver to be turned down for a life insurance policy. This scared me so I swore off drinking several times over the next few years.

In the meantime I started a new love affair with crank. So much so that I was finally able to quit drinking and just do the crank. Originally I snorted crank, then learned to smoke it. I eventually began doing it intravenously. I always considered myself to be immune from AIDS and hepatitis because I didn't share needles. Somehow, I never got into trouble with drugs till I was almost 54 years old. Because of possession for sale of a controlled substance, I was sent to San Quentin State Prison. While in prison I was told by a prison doctor (who had the bedside manner of a parasite) that I had Hep C, Cirrhosis, and Ascites, and that I was going to die.

With that information I decided when I got out of prison that there was no reason for me to not go back to drugs. My health went on a downhill spiral immediately. In 2011, being in such bad shape that I could no longer do drugs, I checked myself into an alcohol and drug rehab. After a few months in this program, I heard that there were treatments available for people with Hep C. I went to my insurance who referred me to a primary care doctor. I told him I had Hep C and he referred me to a GI who does a lot of work with people with Hep C. My GI did a lot of blood work on me. My viral load of Hep C was 7.4 million which is extremely high. In his estimate, I probably contracted it over 30 years ago (long before I even started using needles.) He then explained how easily this virus is spread. All the time I thought I was protecting myself by only using new needles, I probably already had this disease. I can't pin down a time or event to when I got it, but knowing how many ways it can be spread sure let me know it could have been any of hundreds of times and/or situations.

Enough of that. My GI suggested that I get started on triple-therapy treatment with Interferon, Ribavirin, And Incivek. While waiting for approval from my insurance, a friend of mine told me about a support group on facebook for people with the disease. I joined this group (Hepatitis C Family and Friends) about 1 month prior to starting treatments. Here I was given information about what to expect from treatment and questions I should ask my doctor. People on this site have helped me get through the first 5 months of treatments so far. It has been a very rough ride for me. I have suffered almost every possible side effect and may have invented a few of my own. LOL. Anyway, without the support of this loving and caring group, I would probably given up on treatments a few weeks into it. My Hep C virus has been undetectable since week 4. That doesn't mean I am cured, simply means the treatments are working. I still have 6 months of treatments and I know with the continued love and support of this group, and the prayers to a loving God that I have recently learned to appreciate, I can and will make it through this. I will someday be doing the happy dance with so many others who have fought this dragon and won.

I will finish my story with 3 things. #1 Getting clean and sober has saved my life and I have never left the rehab. I am now on staff as a manager and counselor. I want to help others who want to stop destroying their lives. #2 Having this disease, going through treatments, and finding this wonderful support group has taught me a whole new level of humility, faith, and gratitude. My 3rd and final comment will be about getting tested for Hepatitis C. As I mentioned above, I probably had this virus long before I stuck a needle in my arm. There are so many different ways to contract this disease. Unless you live in a germ-free, virus-free environment, you would be as foolish as I was to think you are immune to being infected. Although I probably got mine from something related to the drug environment I lived in, you don't have to use or be around drugs to get it. Get tested. Be safe. New treatments coming out have minimal side effects and great results.

HIV Screening for New Inmates Has Low Yield

Published: Nov 27, 2013

By Michael Smith, North American Correspondent, MedPage Today

Screening for HIV among people entering a prison system might not pick up a lot of new cases, researchers reported.

In an 11-month period, HIV testing of new inmates in North Carolina found that 1.45% of them had HIV, according to David Wohl, MD, and colleagues at the University of North Carolina in Chapel Hill, N.C.

But only a handful of those cases -- less than 0.1% -- were previously undiagnosed, Wohl and colleagues reported in the Nov. 27 issue of the Journal of the American Medical Association.

The finding suggests that undiagnosed HIV might be relatively rare among prisoners, contrary to the common perception that prisons are hotbeds of unknown infections, Wohl argued.

"The whole concept is let's screen these people because we'll find undetected, undiagnosed HIV; that there's going to be a wellspring of undetected HIV," he told MedPage Today. "We found that was not the case at all in our state."

In North Carolina, an HIV test on prison entry was voluntary during the study period in 2008-2009, but a syphilis test was mandatory, Wohl and colleagues noted.

HIV testing is now mandatory in the state's prisons, Wohl said.

The researchers used excess blood from the syphilis tests for an HIV assay, but before the HIV results were de-identified, they were compared with the North Carolina Department of Health and Human Services HIV testing database.

Of the 23,373 people who entered the system from June 2008 through April 2009, 22,134 (94.7%) had sufficient excess blood to allow HIV testing.

All told, 320 inmates (1.45%) were HIV-positive, but 300 were already known to be infected with HIV.

In other words, just 20 of 22,134 new inmates were HIV-positive -- 0.09% -- and not previously known to be, Wohl and colleagues found.

Among the 1,239 new inmates without enough excess blood for HIV testing, 1,066 had a voluntary test in prison and 36 (4.8%) were HIV-positive. All 36 were previously known by the state health department to be infected, Wohl and colleagues reported.

"I was astounded that 94% of people coming into prison who have HIV were already known to have HIV," Wohl said.

The study suggests that aggressive testing in prisons is unlikely to reap a good yield of new HIV cases, Wohl said.

"If you want to go find a place where there's a lot of people undiagnosed with HIV, the prison population in North Carolina is not it," he said.

The prevalence of HIV among the new inmates -- about 1.43% among all of those who were tested -- is about the same as the CDC estimate of 1.4% among the national prison population, both state and federal.

Other researchers have found relatively high rates of HIV among people held in local jails, usually for short periods of time, before they are released or sent on to prison.

But it's "likely that the prison population is fairly representative of what we're talking about in jails," Wohl said, although the jail population is larger.

Wohl and colleagues cautioned that it's possible that a known HIV diagnosis might have resulted from screening during a previous prison term, although almost half the people with a known infection had not previously been incarcerated.

They also noted that North Carolina has the eighth highest HIV prevalence in the U.S. and the findings of the study might not apply to other states.

The study had support from the National Institute of Mental Health and the University of North Carolina Center for AIDS Research.

Wohl reported financial links with Janssen, Gilead, GlaxoSmithKline, and ViiV.

Primary source: Journal of the American Medical Asssociation
Source reference: Wohl DA, et al "Detection of undiagnosed HIV among state prison entrants"JAMA 2013; 310(20): 2198-2199.

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By Andrew Gregory 26 Nov 2013 23:59

Stilton-cheese-2853574

Originally developed for farmers to test the ripeness of their product, medics have now found it can detect the life-threatening condition

Lives could be saved thanks to cutting wedge technology – a cheese scanner which can spot liver disease.

Originally developed for farmers to test the ripeness of their product, medics have now found it can detect the life-threatening condition before symptoms appear.

Liver disease affects two million people in the UK and kills 12,000 a year.

While testing for other uses of the Fibroscan, experts discovered it can be used to measure the elasticity of livers.

An ultrasound probe with the £80,000 device, which uses sound waves to assess tissue damage, takes 10 minutes.

The team behind the idea at Nottingham University Hospitals NHS Trust won an NHS Innovation Challenge prize and £100,000 to develop it further.

Dr Neil Guha, part of the pilot, said: “It targets early asymptomatic liver disease at a critical stage when it is still reversible.”

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New hep C treatments set to overturn US market, says study

Provided by PharmaTimes

WORLD NEWS | NOVEMBER 27, 2013

LYNNE TAYLOR

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The upcoming US market launches of two new hepatitis C virus (HCV) treatments will result in current triple- and dual-therapy regimens losing considerable market share, according to new research from BioTrends Research Group.

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US docs hold back patients until new HCV drugs arrive

Following the launches of Gilead’s sofosbuvir and Janssen/Medivir’s simeprevir, the currently-marketed triple-therapy regimens based on Vertex’s Incivek (telaprevir) and Merck & Co’s Victrelis (boceprevir), and dual-therapy HCV regimens, will lose market share to these new arrivals, says the study.

When asked about treatment practices in the next six months, physicians surveyed for the study reported that they plan to treat 17% of their genotype 1 and 21% of their actively-treated genotype 2/3 HCV patients with a sofosbuvir- and/or simeprevir-containing regimen.

The study also finds that the majority of surveyed US physicians report, unaided, that they are currently “warehousing” HCV patients in anticipation of new therapies, with nearly 30% of this warehousing specifically attributed to waiting for access to sofosbuvir/polymerase inhibitors.

While most surveyed physicians said that they are warehousing treatment-naive and treatment-experienced patients as they wait for the approval of simeprevir, sofosbuvir and/or other interferon-free therapy options, only 12% of surveyed physicians indicated that they are satisfied with currently-approved therapies, it adds.

“In anticipation of availability of new directly-acting antivirals, the shift in the HCV treatment paradigm is already apparent,” said BioTrends Research Group analyst Sandra Renz.

“With the imminent approval of simeprevir and sofosbuvir – agents offering potentially shorter treatment duration, possible interferon-free regimens, improved safety and tolerability profiles and higher cure rates – physicians are eagerly awaiting these new regimens and holding off on prescribing treatment until they are part of the arsenal,” she added.

The study also finds that at least one-third of surveyed physicians have received a patient request for one of the currently-available HCV brands in the past month. Further, a subset of surveyed doctors has already received patient requests for sofosbuvir and simeprevir, suggesting that awareness of these products exists among patients even ahead of their anticipated US launch later this year, it adds.

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