Value through Innovation25 July 2014
21 September 2011

Viramune® (nevirapine) prolonged-release once-daily formulation for the treatment of HIV-1 infection receives approval in the EU

Ingelheim, Germany, September 21, 2011 – Boehringer Ingelheim announced today that once-daily Viramune® (nevirapine) prolonged-release has received approval for use in the EU.1 The new, prolonged-release tablet is indicated in combination with other antiretroviral medications for the treatment of HIV-1 infection.

EU approval for the use of one 400 mg tablet once daily for adults and adolescents - and for 50 mg and 100 mg strengths for once-daily treatment of children - is based on results from clinical trials confirming the significant therapeutic benefits of nevirapine when administered in a convenient once-a-day formulation.2,3

The Viramune® XR™ single 400 mg tablet once daily was approved in the USA by the Food and Drug Administration (FDA) earlier this year.

In clinical trials, the antiviral efficacy of Viramune® prolonged-release tablets was shown to be non-inferior to the older, twice-daily immediate-release (IR) 200mg tablet,2,3 with a safety and tolerability profile comparable to nevirapine IR.

Dr. Keikawus Arastéh

Dr. Keikawus Arastéh

Dr. Keikawus Arastéh, Director of Internal Medicine at Vivantes Auguste-Viktoria-Klinikum, Berlin, Germany, commented: “Nevirapine prolonged-release provides physicians and patients with a simplified, once-daily treatment while maintaining the high level of efficacy, comparable tolerability and favourable lipid profile already associated with the nevirapine immediate-release formulation.”

He added: “Switching therapies and a low pill burden can improve treatment adherence, which is often key to treatment success.”

Professor Klaus Dugi

Professor Klaus Dugi

Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim Headquarters, stated: “Data show that Viramune® prolonged-release, combines the trusted clinical benefits of nevirapine with the convenience of a single tablet, once daily dose. Nevirapine prolonged-release allows an easy switch for patients currently taking nevirapine twice-daily.”

“Viramune® prolonged-release tablets give patients a simplified treatment option without compromising on clinical efficacy and fits in with today’s prescribing trends,” he added.

Notes to Editor:

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the USA.

About Viramune®
Viramune® (nevirapine) is a product of original research carried out at Boehringer Ingelheim. Nevirapine was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs and is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. This indication is based on a principal clinical trial that demonstrated prolonged suppression of HIV-RNA and several smaller supportive studies. Studies have also shown that patients switching to nevirapine from a PI-based regimen demonstrate an improved lipid profile while maintaining viral suppression. The clinically most important adverse events associated with nevirapine are rash and hepatic events, which have included fatal cases. The greatest risk of severe rash and hepatic events occurs in the first six weeks of therapy. It is essential that patients are monitored for these reactions at all times, and intensively during the first few months of therapy. Nevirapine should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions.

About the VERxVE Study
VERxVE is a randomised, double-blind, double-dummy, parallel group, active controlled, multinational trial conducted to evaluate the antiviral efficacy and safety of once-daily nevirapine 400 mg compared to twice-daily nevirapine 200 mg. A total of 1,011 adult patients were randomised to receive either nevirapine prolonged-release or nevirapine immediate-release after a 14-day lead-in period with nevirapine immediate-release for all patients. All patients also received a nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) backbone of Truvada®.*

Results after 48 weeks indicated that of the patients who received nevirapine prolonged-release in the study, 81 percent (404/505) vs. 76 percent (379/506) of patients taking nevirapine immediate-release (200 mg) achieved the study endpoint of viral load <50 copies/mL in the week 48 +/- 4 window according to the primary endpoint using the Time to Loss of Virologic Response (TLOVR) algorithm. This demonstrated non-inferiority of nevirapine prolonged-release to nevirapine immediate-release. In patients with an HIV-RNA>100,000 copies/mL at baseline, the response rate was 73 percent for nevirapine prolonged-release vs. 71 percent for nevirapine immediate-release. In patients with baseline HIV-RNA≤100,000 copies/mL, the response rate was 85 percent for patients taking nevirapine prolonged-release compared to 79 percent for patients taking nevirapine immediate-release.

VERxVE results also showed that nevirapine prolonged-release had a safety and tolerability profile comparable to nevirapine immediate-release in treatment-naïve patients. After the lead-in period, the incidence of any hepatic event was six percent for adult patients taking nevirapine prolonged-release and nine percent for adult patients taking nevirapine immediate-release. The rate of symptomatic hepatic events was comparable in adult patients taking nevirapine prolonged-release to those patients taking nevirapine immediate-release (two percent vs. three percent).

* Truvada® is a registered trademark of Gilead Sciences, Inc.

About the TRANxITION Study
The TRANxITION study examined the efficacy and safety of switching virologically-suppressed patients (viral load < 50 copies/ml) from nevirapine immediate-release 200mg twice-daily to nevirapine prolonged-release 400mg once-daily.

TRANxITION is an open-label, parallel group, non-inferiority, randomised study (2:1 randomisation nevirapine prolonged-release: nevirapine immediate-release). Adult HIV-1 patients receiving nevirapine immediate-release plus fixed-dose NRTI combinations with undetectable viral load (VL) were enrolled. The primary endpoint was continued virologic suppression with VL <50 copies/mL through Week 24. In the study, 443 patients from the USA and Europe were treated; 295 switched to nevirapine prolonged-release and 148 continued on nevirapine immediate-release. Continued virologic suppression was observed in 93.6 percent (276/295) with nevirapine prolonged-release and in 92.6 percent (137/148) with nevirapine immediate-release at 24 weeks of follow-up. Non-inferiority (adjusted margin of -10 percent) of nevirapine prolonged-release to nevirapine immediate-release was demonstrated. The rate of severe adverse events was low and comparable between both treatment groups (3.7 percent and 4.1 percent with the prolonged-release and immediate-release formulations respectively). The study supports the switch from nevirapine immediate-release twice-daily to nevirapine prolonged-release once-daily in patients who are virologically suppressed.

Safety Information
The most common side effect of nevirapine is rash, which can be severe or life-threatening. The most serious adverse reactions associated with nevirapine are hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failure may be isolated or associated with signs of hypersensitivity, which may include severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis (pink eye), facial edema, eosinophilia (an abnormally high number of eosinophils in the blood), granulocytopenia (an abnormally low concentration of granulocytes in the blood), lymphadenopathy (swelling/enlargement of the lymph nodes), or renal dysfunction.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. With headquarters in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to be socially responsible including involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24% of net sales in its largest business segment, Prescription Medicines on research and development.

 

References

1. European Medicines Agency
2. Gathe J et al. Efficacy and safety of nevirapine extended- release once daily versus nevirapine immediate-release twice-daily in treatment-naïve HIV-1 infected patients. Antiviral Therapy 2011;16 (epub ahead of print)
3. Arastéh K et al. 24 Wk Efficacy and Safety of Transitioning Virologically Stable HIV-1 Patients from IR Nevirapine 200 mg BID to Nevirapine XR 400 mg QD. 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Boston, MA, USA, September 12-15, 2010: Poster: 207

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    Boehringer Ingelheim

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    Sebastian Wachtarz
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    55216 Ingelheim am Rhein

    GERMANY

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