The first batch of the new triple-combination first-line HIV treatment regimen was recently produced at the Cipla Quality Chemical Industries Limited (CiplaQCIL) manufacturing facility in Kampala, Uganda. Cipla is currently the only facility to manufacture this antiretroviral fixed-dose combination – commonly referred to as TLD, and comprising tenofovir (TDF), lamivudine (3TC) and dolutegravir (DTG) – according to the World Health Organisation’s stringent quality standards.
Samuel Opio, Cipla’s company pharmacist on the manufacturing element, described production of TLD as very complex because it involves three different processes, relating to the three active pharmaceutical ingredients (APIs). In addition to the considerable technology and infrastructure investment required, there are also complexities pertaining to the double coating and compression of the tablet, whereafter the tablet undergoes exhaustive testing.
CEO of CiplaQCIL, Nevin Bradford, said the production of TLD affirms Cipla’s commitment to pioneering innovation and, as a result, ensuring that affordable, quality medication is produced in Africa for patients in Africa. To guarantee security of medication supply and to cope with the increased product demand, CiplaQCIL recently increased its production capacity from 80 million to 130 million tablets per month.
Manufacturing in Africa for Africa ensures improved speed to market of WHO quality-assured medicines because of proximity to the patients. According to the World Bank and the United Nations Sustainable Development Goals, “manufacturing is a principal driver of economic development, employment and social stability”. Cipla’s manufacturing investment helps drive both the economic and medical health of individuals and communities.
Bradford said: “We’re proud that CiplaQCIL is able to deliver on its promise to the Ugandan Ministry of Health to ensure that this new first-line therapy is available to patients in Uganda, as the roll-out starts to male patients.”
CEO of Cipla South Africa, Paul Miller, said: “This manufacturing milestone means that patients will benefit immensely by means of accelerated access to the new affordable, fixed-dose combination drug containing dolutegravir. DTG is considered a best-in-class medicine providing many clinical benefits for people living with HIV. With DTG replacing efavirenz (EFV) in the first-line fixed dose combination treatment, thereby reducing the likelihood of treatment failure, TLD has the potential to reduce overall treatment costs.”
Clinical studies demonstrate treatment regimens including DTG are more effective because it has fewer side effects, fewer reported incidents of HIV drug resistance, fewer drug-drug interactions and has a more rapid ability to suppress the viral load. In addition, the smaller pill size will improve treatment adherence.
Submission for regulatory approval of Cipla’s TLD has already been sought from the National Drug Authority of Uganda, and once this is finalised, Cipla can begin distribution of the medication.
Nevin stated: “We believe it may be the first time batches of the new triple combination have been manufactured anywhere in the world outside India.” Who can we speak to confirm this?