According to the World Health Organisation (WHO), in 2017 there were an estimated 322 000 cases of active TB in South Africa, while in 2011 there was an estimated incidence of 500 000 cases

Pill burden is one of the factors contributing to treatment adherence for people who take HIV and TB medication simultaneously. Cipla South Africa has come up with a new combination therapy — Cotrizid — as a solution. 

Fixed-dose solution

The South African Health Products Regulatory Authority (SAHPRA) has also approved this innovative fixed-dose combination medicine, which combines sulfamethoxazole, trimethoprim, isoniazid and pyridoxine (vitamin B6) into a single tablet. The WHO recommends its use for up to three years for people living with HIV who also live in high-risk TB communities.

 According to Cipla, this fixed-dose combination tablet is a unique first-to-market product in South Africa and helps to reduce the pill burden for people living with HIV. Their statement further says that higher pill burden is associated with lower adherence rates and subsequently reduces the chances of achieving desired outcomes, including reduced TB prevalence and an undetectable HIV viral load.

 Heavy pill burden

Health-e News speaks to Luckyboy Mkhondwane from Duduza, who has been on both HIV and TB treatments back in 2005. 

“When I started ART in 2005, I was coinfected with TB and Mycobacterium Avium Complex which is a bacterial infection related to TB; and this meant that the number of pills I had to take had to increase,” says Mkhondwane.

These were the days when there was no FDC for management of HIV. 

“My ART combination was Stavudine, Lamivudine and Efavirenz, which meant that I had to take five pills a day, and in addition to that I was taking five Rifafour for TB, plus an extra dose of Ethambutol together with Clarithromycin and Moxifloxacin,” they tell Health-e News.

Mkhondwane adds that they also took vitamin B complex, nicotinamide, folic acid, vitamin B 12 and Cotrimoxazole. All-in-all, Mkhondwane took 26 pills a day.

They further explain that the importance of the new therapy lies in the fixed-dose aspect — most significantly, prophylaxis commonly used to prevent several diseases amongst people living with HIV, sulfamethoxazole and trimethoprim (also known as Bactrim or Cotrimoxazole) is used to prevent and treat a number of infections quite common in people living with HIV such as Pneumocystis carinii pneumonia.

“Having these in a fixed-dose combination is the answer we were looking for to reduce the pill burden for people who need to take them as prophylaxis,” they add.

While pill burden can contribute to people neglecting their treatment and default, Mkhondwane says effective counselling is also needed when people are initiated into these treatment cycles.

 “I think this combination therapy is important for us, as South Africans as we have a high prevalence rate of TB and also living with HIV; and due to people reporting late for ART initiation the number of advanced HIV diseases is on the rise. This means the need for prophylaxis is even higher,” they tell Health-e News.

Context-suited treatment

According to Cipla’s statement on the new TB drug, Cotrizid has shown notable efficacy in preventing TB, particularly during the crucial early months of HIV treatment, when the CD4 count is low and the risk of TB infection is highest. The REALITY study compared enhanced prophylaxis, including Cotrizid, with standard prophylaxis, both in combination with antiretroviral therapy for advanced HIV infection in Africa. The outcome at 48 weeks indicated that this enhanced prophylaxis was associated with significantly lower rates of newly diagnosed TB as well as significantly lower rates of HIV/AIDS complications and death.

The CEO of Cipla South Africa, Paul Miller, says they are pleased this product can now be made available locally, specifically given the high incidence of HIV and TB in the country. “Cotrizid is suited for severely immune-compromised people (for example, PLHIV with a CD4 count of less than 200) as the medicine also protects against opportunistic infections,” says Miller. — Health-e News