The South African Health Products Regulatory
Authority (SAHPRA) has approved Cipla’s latest first-line triple-combination
antiretroviral (ARV) treatment for HIV. The new combination medicine commonly
referred to as TLD, is a combination of tenofovir (TDF), lamivudine (3TC) and
dolutegravir (DTG).

In future, TLD will be manufactured at
Cipla’s facilities in Durban and Uganda, reinforcing Cipla’s commitment to
produce medicines in Africa for Africa and ensuring more affordable treatment
for patients.

Head
of Manufacturing for Cipla South Africa, Ajay Kumar Pal, said the reason for
the new formulation complexity related to the three different processes
required for the three active pharmaceutical ingredients (APIs).  In
addition to the considerable technology and infrastructure investment of more
than R48m (including a machine worth R16m), there are also additional
complexities pertaining to the double coating and compression of the tablet,
and the product also undergoes exhaustive testing at different stages of
manufacturing.

Cipla
has a legacy of pioneering affordable ARVs: in 2001, it produced the
world-first three-in-one fixed combination drug, available at less than $1 per
day, thereby enabling countless more patients to have access to life-saving
medication. This new fixed-dose combination – an addition to Cipla’s
comprehensive portfolio of HIV medication – is recommended by the World Health
Organisation (WHO) as a preferred first-line regimen.

Cipla
South Africa CEO, Paul Miller, said: “We’re always focused on ensuring that
patients benefit by having access to quality, affordable ARVs. 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.”

According
to UNAIDS, “antiretroviral therapy using dolutegravir has several advantages
over other regimens, including clinical superiority, improved side-effect
profile, and reduced risk of viral resistance”.

 

Source:
Cipla media release