New Delhi, Nov 30: Drug major Cipla Ltd today said it is ready to launch low dose ‘Efavirenz’ used in treatment of HIV infection.
On the eve of World AIDS day, the company 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”, Cipla said in a BSE filing.
“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,” it added.
Cipla further said: “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.”
Citing UNAIDS data, Cipla said there are approximately 37 million people worldwide 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.
The company said Efavirenz 400 mg, will also significantly reduce the cost of treatment.
“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,” it added.
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, Cipla said.