Results from multiple Phase 1 studies evaluating the interaction between telaprevir and ritonavir-boosted protease inhibitors, NNRTIs and NRTIs (Abstract #119)

— Telaprevir slightly increased the exposure to ritonavir-boosted

atazanavir. Ritonavir-boosted atazanavir slightly reduced the exposure

to telaprevir. This interaction was not considered to be clinically

significant. a HIV regimen that includes ritonavir-boosted atazanavir is

being evaluated in an ongoing Phase 2 study of telaprevir-based therapy

in people infected with both hepatitis C and HIV.

— an interaction between efavirenz and telaprevir (750 mg, every eight

hours) was observed, but a higher dose of telaprevir (1,125 mg, every

eight hours) could largely offset the interaction. This higher dose of

telaprevir is being evaluated as part of an ongoing Phase 2 study in

people co-infected with hepatitis C and HIV who are also receiving

efavirenz as part of their HIV treatment.

— Significant interactions were observed between telaprevir and

boosted-lopinavir, darunavir and fosamprenavir, such that

telaprevir-based combination therapy is not currently being evaluated

for people taking these HIV medicines.

Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. to date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.

Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.

Telaprevir has been granted priority review by the U.S. Food and Drug Administration (FDA) and by Health Canada and accelerated assessment by the European Medicines Agency for the treatment of people chronically infected with genotype 1 hepatitis C virus (HCV). the applications include data from three registrational studies, ADVANCE, ILLUMINATE and REALIZE, which evaluated telaprevir in people with hepatitis C who were new to treatment as well as those who did not achieve a viral cure after treatment with currently available medicines. for complete information on the clinical trials or a fact sheet on the trial designs visit: vrtx.com/press.cfm.

About Hepatitis C and HIV Co-Infection

there are 1 million people living with HIV in the United States.(2) It’s estimated that up to 30 percent of people living with HIV/AIDS are also infected with hepatitis C.(3) there have been dramatic improvements in the treatment of HIV and the prognosis for people living with HIV. However, liver disease progresses more rapidly in people co-infected with hepatitis C and HIV, with an increased rate of progression to cirrhosis, decompensated liver disease, hepatocellular carcinoma and death.(3,4,5)

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.(6) Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.(6) though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.(6) Approximately 60 percent of genotype 1 hepatitis C patients who undergo treatment with an initial 48-week regimen with pegylated-interferon and ribavirin, the currently approved medicines, do not achieve SVR,(7,8,9) or viral cure.(10) if treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.(11,12,13,14,15)

more than 170 million people worldwide are chronically infected with hepatitis C. In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.(16) the majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.(15) Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.(12) by 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.(15)

PEGASYS(R) and COPEGUS(R) are registered trademarks of Hoffman-LA Roche.

Reyataz(R) is a registered trademark of Bristol-Myers Squibb.

Atripla(R) is a registered trademark of Bristol-Myers Squibb and Gilead Sciences, LLC.

Special Note regarding Forward-looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding (i) the interim results being encouraging because they showed a high proportion of people in the study had a rapid response to telaprevir; (ii) Vertex’s plan to use what it is learning from the study to inform a Phase 3 co-infection study of telaprevir planned for the end of 2011; (iii) expectations that final SVR results from the study will be available in 2012 and (iv) the possibility that a higher dose of telaprevir could largely offset the interaction observed between efavirenz and telaprevir. While Vertex believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. those risks and uncertainties include, among other things, the risks that efforts to develop telaprevir as a treatment for patients co-infected with genotype 1 HCV and HIV may not proceed due to technical, scientific, commercial, financial or other reasons; that final outcomes, including SVR rates, from this clinical trial and any future clinical trials of telaprevir in patients with HCV-HIV co-infection may not be favorable; that RVR and cEVR may not be predictive of SVR in patients with HCV-HIV co-infection and the other risks listed under Risk Factors in Vertex’s annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex’s website at vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize innovative therapies so people with serious diseases can lead better lives.

Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.

for more information and to view Vertex’s press releases, please visit vrtx.com.

References: (1) 2010 Guidelines for Antiretroviral Treatment of HIV From the International AIDS Society-USA Panel JAMA. 2010;304(17):1897. (2) Centers for Disease Control and Prevention. HIV/AIDS and Viral Hepatitis. available at cdc.gov/hepatitis/Populations/hiv.htm. Accessed February 17, 2011. (3) Health Resources and Services Administration. Care and Treatment for Hepatitis C and HIV Co-infection. available at hab.hrsa.gov/tools/coinfection/coinfectionsub.html and hab.hrsa.gov/tools/coinfection/index.html Accessed February 28, 2011. (4) Benhamou Y, Bochet M, Di Martino V, Charlotte F, Azria F, Coutellier a, et al. Liver fibrosis progression in human immunodeficiency virus and hepatitis C virus coinfected patients. Hepatology 1999;30(4):1054-58. (5) Martin-Carbonero L, Benhamou Y, Puoti M, Berenguer J, Mallolas J, Quereda C, et al. Incidence and predictors of severe liver fibrosis in human immunodeficiency virus-infected patients with chronic hepatitis C: a European collaborative study. CID 2004;38:128-33. (6) Martinez-Sierra C, Arizcorreta a, Diaz F, Roldan R, Martin-Herrera M, Perez- Guzman E, et al. Progression of chronic hepatitis C to liver fibrosis and cirrhosis in patients coinfected with hepatitis C virus and human immunodeficiency virus. CID 2003;36:491-8. (7) Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. available at: cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed May 25, 2010. (8) Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965. (9) Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982. (10) McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593. (11) Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; an update. Hepatology. 2009;49 (4):1-40. (12) Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology.

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Press Release Source: Tibotec Therapeutics on Monday December 13, 2010, 6:37 pm EST

TITUSVILLE, N.J., Dec. 13, 2010 /PRNewswire/ — Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., announced today that the U.S. Food and Drug Administration (FDA) has approved a revision to the dosing recommendation to include once-daily dosing of PREZISTA® (darunavir) tablets in combination with ritonavir for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients with no darunavir resistance-associated mutations (DRV RAMs).(1)  

The revised dosing recommendation extends the same dosing already approved for treatment-naive patients – PREZISTA, co-administered with ritonavir (in combination with other antiretroviral agents and with food, once-daily (800/100 mg) – to treatment-experienced patients with no DRV RAMs. the previously approved dosing recommendation for PREZISTA/ritonavir in treatment-experienced patients (patients who have taken HIV medications in the past) was PREZISTA/ritonavir 600/100 mg twice daily.  

For antiretroviral treatment-experienced patients, genotypic testing is recommended. However, when genotypic testing is not feasible, PREZISTA/ritonavir 600/100 mg twice daily dosing is recommended.

The approval of this revision is based on 48-week data from the ODIN (Once-daily Darunavir In treatment-experieNced patients) study. ODIN evaluated the efficacy and safety of PREZISTA/ritonavir once daily vs. PREZISTA/ritonavir twice daily for the treatment of HIV-1 in treatment-experienced adult patients with no DRV RAMs (i.e., V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, or L89V).

“With this once-daily dosing recommendation, boosted PREZISTA is now a viable option for more treatment-experienced patients,” said Glenn Mattes, president, Tibotec Therapeutics. “This approval reflects Tibotec’s ongoing commitment to optimizing dosing strategies for HIV patients.”  

Data from the Phase 3b ODIN study were presented earlier this year at CROI 2010, the 17th Conference on Retroviruses and Opportunistic Infections, in San Francisco. the study achieved its primary objective of demonstrating non-inferiority of PREZISTA/ritonavir once daily compared with twice daily.

PREZISTA Indication: Adults

PREZISTA, co-administered with ritonavir and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection.

This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from two controlled, Phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients, and two controlled, Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients.

In treatment-experienced adult patients, the following points should be considered when initiating therapy with PREZISTA/ritonavir:

• Treatment history and, when available, genotypic or phenotypic testing, should guide the use of PREZISTA/ritonavir.

• The use of other active agents with PREZISTA/ritonavir is associated with a greater likelihood of treatment response.

About the ODIN Study

ODIN is a Phase 3b, randomized, open-label study that compared the efficacy, safety, and tolerability of PREZISTA/ritonavir 800/100 mg once daily versus PREZISTA/ritonavir 600/100 mg twice daily at week 48 in 590 treatment-experienced HIV-1-infected adult patients with no DRV RAMs (V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V). Patients had HIV-1 RNA greater than 1,000 copies/mL and CD4 count greater than 50 cells/mm(3), and received a stable antiretroviral therapy regimen for greater than or equal to 12 weeks at screening. Patients received either once-daily (n=294) or twice-daily (n=296) PREZISTA/ritonavir plus optimized background regimen. the primary objective of the study was to demonstrate non-inferiority of PREZISTA/ritonavir 800/100 mg once daily versus PREZISTA/ritonavir 600/100 mg twice daily in confirmed virologic response (HIV-1 RNA less than 50 copies/mL [intent-to-treat/time-to-loss of virologic response; ITT-TLOVR]) at Week 48.

Important Safety Information

PREZISTA does not cure HIV-1 infection or AIDS, and does not prevent passing HIV-1 to others.

Drug Interactions

• Coadministration of PREZISTA/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (e.g., alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide, oral midazolam, triazolam, lovastatin, or simvastatin)

• Coadministration of PREZISTA/ritonavir is also contraindicated with rifampin and products containing St. John’s wort (Hypericum perforatum) because this may cause significant decrease in plasma concentration of darunavir, resulting in loss of therapeutic effect and development of resistance

• Coadministration is not recommended with indinavir, lopinavir/ritonavir, saquinavir, and pravastatin

• Caution should be used when prescribing agents such as sildenafil, vardenafil, tadalafil, or other substrates, inhibitors, or inducers of CYP3A in patients receiving PREZISTA/ritonavir.

• This list of potential drug interactions is not complete.

Warnings & Precautions

• PREZISTA must be coadministered with ritonavir and food to achieve the desired antiviral effect. Failure to administer PREZISTA with ritonavir and food may result in a loss of efficacy of darunavir. Please refer to ritonavir prescribing information for additional information on precautionary measures

• Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA/ritonavir. during the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA/ritonavir. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse events

Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA/ritonavir therapy has not been established

Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of PREZISTA/ritonavir treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/ritonavir should prompt consideration of interruption or discontinuation of treatment

• Severe Skin Reactions:  Severe skin reactions (0.4%), accompanied by fever and/or elevations of transaminases in some cases, Stevens-Johnson Syndrome (
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