WHO’s Prequalification Project has added three new generic products for first-line HIV treatment to its list of medicines meeting WHO standards of quality, safety and efficacy. The products are fixed-dose triple therapy combinations containing lamivudine, stavudine and nevirapine. Their introduction in the list of prequalified medicines will increase choice and competition, thus contributing to make HIV treatment progressively more affordable.
The 3 by 5 strategy recommends simplified HIV treatment regimens so that countries can quickly expand access to antiretroviral medicines. These new products will help countries which are hardest-hit by the HIV epidemic get easy-to-take medicines to the people who need them most urgently. Single-pill combinations of antiretrovirals are a major breakthrough for treatment in poor countries as they improve the reliability and security of supplies, which has so far been one of the major obstacles to access. From a therapeutic point of view, they reduce the number of pills, are easier to take and promote greater patient compliance. They also ensure that the right dosage of each substance is given to the patient.
At present, the prequalification list contains over 50 single-drug, two-drug, and three-drug combinations, including the three newly qualified products. In assessing products and their manufacturers, prequalification provides a rigorous review process and ongoing quality monitoring. One of the benefits of this initiative is that it limits the entry of substandard and counterfeit medicines into the supply channels. In addition, the project helps build local regulatory and production capacity by involving local experts in the evaluations. Prequalification also respects intellectual property rights while reflecting the highest public health standards.
Reference: http://www.who.int/3by5/en/ and www.who.int/medicines0