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My Review: Love and Other Drugs (6/10)

 Based on the initial results of the study, which failed disappointingly, Merck the the U.S. based drugmaker announced that it was ending the Phase III study, which could have paved the way for wider use among previously untreated HIV or AIDS patients. Isentress is a leading drug for Merck and it is also one of the  fastest-growing drugs treating HIV-1 patients  . Its sales in the third quarter was $278 million, putting it on track to become a $1 billion-a-year drug for the company. Some analysts have predicted the drug to bring in 2 Billion annually by 2015.

Merck stocks took a bit of dive after the announcement. 

Following is the press release by Merck

WHITEHOUSE STATION, N.J., Nov. 29, 2010 - Merck today reported initial results from the Phase III study investigating the efficacy and safety of a treatment regimen including ISENTRESS^® (raltegravir) Tablets once daily in treatment-naïve adult patients infected with HIV-1. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adults. In the study, although the treatment regimen that included ISENTRESS once daily enabled more than 80 percent of patients to achieve viral suppression, ISENTRESS once daily did not demonstrate non-inferiority to the treatment regimen that included ISENTRESS twice daily. Merck said that based on the initial results and following the recommendation of an independent Data Monitoring Committee, Merck will end the study. Merck is notifying clinical investigators of this decision this week and is recommending that patients enrolled in the once-daily dosing arm of the study be switched to ISENTRESS twice daily, the FDA-approved dose. Results from this study will be submitted for presentation at an appropriate scientific meeting in 2011.

This Phase III study evaluated the safety and efficacy of an investigational once-daily dose of raltegravir (800 mg once daily) versus the approved twice-daily dose (400 mg twice daily), each given in combination with a once-daily fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, in adult treatment-naïve HIV-1-infected patients. In this study, 775 patients were randomized, and 770 patients received study drug and are included in the current analyses. After 48 weeks in the study, 83.2 percent (n=318/382) of patients receiving the regimen including ISENTRESS once daily achieved undetectable viral levels (HIV-RNA <50 copies/mL), compared to 88.9 percent (n=343/386) of patients receiving the regimen including ISENTRESS twice daily. The treatment difference between the 800 mg once daily group and 400 mg twice daily group was -5.7 percent, with an associated 95 percent confidence interval (CI) of (-10.7 percent, -0.83 percent). The difference did not meet the pre-defined statistical criteria for non-inferiority.

The overall treatment difference observed between the once-daily and twice-daily groups was primarily due to results in patients with high viral load. Among patients with more than 100,000 copies/mL of HIV-RNA, 74.3 percent (n=113/152) of those in the once-daily group achieved viral suppression compared to 84.2 percent (n=128/152) of those in the twice-daily group. The safety and tolerability profiles of the two regimens were similar in the study, and were consistent with current labeling for ISENTRESS.

About ISENTRESS

ISENTRESS is Merck's integrase cheap viagra for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adult patients. ISENTRESS currently is the only approved integrase cheap cialis for the treatment of HIV-1. The label for ISENTRESS is based on analyses of plasma HIV-1 RNA levels through 96 weeks in three double-blind controlled clinical studies of ISENTRESS. Two of these studies were conducted in clinically advanced, three-class antiretroviral (ARV) [non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitor (PI)] treatment-experienced adults and one was conducted in treatment-naïve adults. The safety and efficacy of ISENTRESS have not been established in pediatric patients. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.

ISENTRESS is the first medicine to be approved in a class of antiretroviral drugs called integrase inhibitors. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells. Other HIV-1 drugs in use inhibit two other enzymes critical to the HIV-1 replication process – protease and reverse transcriptase – but ISENTRESS is the only approved drug that inhibits the integrase enzyme. ISENTRESS is now approved in more than 90 countries worldwide. Merck is continuing to move forward with filings in additional countries around the world for use of ISENTRESS in both treatment-experienced and treatment-naïve HIV-infected patients.

Important safety information about ISENTRESS

ISENTRESS does not cure HIV or AIDS and does not prevent passing HIV to others. Healthcare providers should know that immune reconstitution syndrome has been reported in patients treated with ARV therapy, which may necessitate further evaluation and treatment.

Creatine kinase elevations were observed in subjects who received ISENTRESS. Myopathy and rhabdomyolysis have been reported. ISENTRESS should be used with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medication known to cause these conditions.

The most commonly reported drug-related adverse event (AE) of moderate to severe intensity that occurred in greater than or equal to 2 percent of patients and at a higher incidence than efavirenz in treatment-naïve patients receiving ISENTRESS was insomnia (4 percent versus 3 percent, respectively).

The most commonly reported (greater than or equal to 2 percent in either treatment group) drug-related clinical AE of moderate or severe intensity in treatment-experienced patients receiving ISENTRESS and at a higher rate compared to placebo was headache (2 percent vs. less than 1 percent) for ISENTRESS plus optimized background therapy (OBT) and placebo plus OBT, respectively.

In treatment-experienced patients, rash occurred more often in patients taking ISENTRESS and darunavir together than with either drug separately. Rashes were mild to moderate in severity and did not limit therapy. There were no discontinuations due to rash.

Dosing and administration

ISENTRESS is a single 400 mg tablet taken twice daily without regard to food. The dose of ISENTRESS should be increased during coadministration with rifampin to 800 mg twice daily.

Drug interactions

Co administration with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 may reduce plasma concentrations of ISENTRESS. Rifampin, a strong inducer of (UGT) 1A1 reduces plasma concentrations of ISENTRESS. Based on the results of drug interaction studies and the clinical trials data, no dose adjustment of ISENTRESS is required when co administered with other ARV agents. Also, preclinical studies show that ISENTRESS is not metabolized by cytochrome P450 enzymes.

For more information, visit www.merck.com.

Intel's spent the last nine months prepping its Oak Trail silicon to improve the battery life and performance of Windows 7 tablets, and come the end of next month we should finally have some slates with the new 1.5GHz Atom Z670 chip inside. While Fudzilla has heard that the cheap cialis will hit in the general March time frame, the eagle-eyed guys at Netbook News spotted the Fujitsu Stylistic Q550 press materials stating that the new platform will launch on March 30, 2011. That seems to line up with what we've heard on timing, since both the Oak Trail-powered Samsung Sliding PC 7 and MSI WindPad 100W were announced with March availability. Chances are we will hear more about it all at CeBIT next week, but honestly, at this point we're just really eager to get one of these in our hands to see what Chipzilla's really improved.

Intel Oak Trail Atom Z670 tablets to arrive at the end of March originally appeared on Engadget on Fri, 25 Feb 2011 18:43:00 EDT. Please see our terms for use of feeds.

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Source: http://feeds.engadget.com/~r/weblogsinc/engadget/~3/5nCtnKIakAQ/

DISCOVER FINANCIAL SERVICES DIODES INORATED DIEBOLD DELL

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School nurses are the best tool we have in fighting some of the biggest health issues facing our country and we must be bold enough to invest in them now.

As anyone who listened to BBC Radio 4’s ‘Case Notes’ yesterday evening http://bit.ly/b4r8d will know, the role of the school nurse has changed dramatically over the last few decades.

We heard how they used to act as ‘hand maids’ whose duties included checking for nits and preparing notes for the onsite doctor.

Their role now could hardly be more different. Today, across the UK, school nurses are leading, not following, and spend their time inoculating, advising and mentoring hundreds of thousand of school children every day.

Whether it’s running sexual cheap cialis clinics, providing the important immunisations or writing detailed care plans for those with chronic conditions – the school nurse is an essential part of child cialis.

For those children lucky enough to have easy access to a school nurse, they are an invaluable tool. They can highlight the dangers of alcohol, smoking and obesity at an age where prevention is more powerful than cure.

However, not all children have the access to school nurses that they need or deserve. A recent RCN survey found that two thirds of school nurses felt overstretched and unsupported by their rising workload, and that government targets to increase the numbers of school nurses are unlikely to be met by the deadline next year.

Furthermore, we found that the average school nurse now looks after more than seven schools, with a quarter looking after more than 10. One nurse questioned looked after 26 schools.

The RCN has campaigned for every child to have access to a school nurse and we will continue to do so. The current shortage must be addressed and we mustn’t allow current financial constraints to threaten this investment.

School nurses are the best tool we have in fighting some of the biggest health issues facing our country and we must be bold enough to invest in them now.