CHMP positive for Delstrigo for HIV.- Merck Inc.,

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Delstrigo (doravirine + tenofovir disoproxil + lamivudine), from Merck Sharp & Dohme, intended for the treatment of HIV -1 infection.

Delstrigo is a fixed dose combination of three active substances, doravirine, lamivudine and tenofovir disoproxil, and will be available as 100 mg/300 mg/245 mg film -coated tablets.

Trials show that the drug is as effective as Atripla for first-time HIV treatment and causes fewer central nervous system and metabolic side effects, according to a report at the 9th International AIDS Society Conference on HIV Science. After 48 weeks on treatment, 84 percent of people taking the doravirine pill and 81 percent of those taking Atripla had undetectable viral load, defined as having HIV RNA below 50 copies per milliliter. Response rates were similar in the doravirine and Atripla groups regardless of whether people started treatment with a high or a low viral load.