Cipla ready to launch low-dose Efavirenz 400 mg

India, Mumbai, November 30, 2015: Today on the eve of World AIDS day, Cipla Ltd. announced its readiness to supply its combinations Tenofovir/ Emtricitabine / Efavirenz and Tenofovir/ Lamivudine /Efavirenz with a dose of 400 mg of Efavirenz as a first-line initial therapy for HIV infection.

Studies now support the use of Efavirenz 400 mg as a substitute for Efavirenz 600 mg in cases where there is no co-infection with tuberculosis. Efavirenz 600 mg is currently used in antiretroviral therapy (ART) and is highly effective. However, it is known to have significant side effects, which can be very distressing for those taking it for treatment of HIV infection.

Efavirenz 400 mg, with the same efficacy, is much better tolerated. It is expected that this improved formulation will help improve patient adherence as well as significantly reduce the cost of treatment. In addition it will also significantly reduce the pill size.

Studies found that the reduced dose of 400 mg Efavirenz was non-inferior to the standard dose of 600 mg Efavirenz dose when combined with Tenofovir/ Emtricitabine (TDF/FTC) and Tenofovir/ Lamivudine (TDF/ 3TC) as initial HIV therapy. Both doses demonstrated similar safety profiles.

According to UNAIDS, there are approximately 37 million worldwide people living with HIV of which around 15.8 million people are reported to be receiving ART. WHO recently announced that it recommended to make ART available to all HIV-infected patients as soon as they are tested positive. This strategy should dramatically decrease HIV transmission but will require large additional resources, as the cost of ART remains substantial in spite of price reductions by manufacturers.

One way to reduce the drug costs of therapy further is "dose optimization". Reducing the dose of Efavirenz in current first-line combination therapy to 400 mg will contribute to reducing costs without modifying the effectiveness of treatment.

It is expected that new guidelines for HIV treatment will include this dose reduction to Efavirenz 400 mg.