Cipla, South Africa’s third largest pharmaceutical manufacturer, hosted an HIV/AIDS workshop in Sandton on Wednesday, ahead of World AIDS Day on 01 December 2019.
The workshop took place on the same day that Health Minister Dr Zweli Mkhize officially launched South Africa’s rollout of the new triple-combination first-line HIV antiretroviral treatment (ART), referred to as TLD, a combination of tenofovir, lamivudine and dolutegravir (DTG). As a result of its multiple benefits (namely improved tolerability and higher barrier of resistance of the virus due to the drugs in the combination pill), the SA government is transitioning patients from TEE (tenofovir, emtricitabine and efavirenz) to TLD.
DTG, an integrase inhibitor approved in the United States by the Food and Drugs Administration (FDA) in 2013, results in the reduction of circulating HIV virus in the blood, measured as the viral load in people living with HIV. When people are virally supressed, they cannot transmit the virus, which means this treatment can help to reduce the number of new infections.
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”.
A combination pill containing DTG is less expensive than other ART drugs to manufacture and will be available to people who are newly diagnosed with HIV, as well as existing patients on an efavirenz-containing regimen and who have been virally suppressed for at least six months.
Co-principal investigator of the ongoing ADVANCE study and head of treatment strategies at Ezintsha, Dr Michelle Moorhouse said: “Efavirenz has been used in South Africa’s public sector ART programme for years now, but it has some drawbacks because the HIV virus easily becomes resistant to it, it is more expensive than TLD at scale and can cause undesired side effects in some people. Through the local-based ADVANCE study, we are comparing two dolutegravir-based ART regimens with an efavirenz-based regimen in people starting ART. We are also comparing the currently used ART backbone containing tenofovir disoproxil fumarate (TDF) to the newer tenofovir alafenamide fumarate (TAF). People starting ART with a dolutegravir-based regimen achieved the same high rates of viral suppression as those starting with efavirenz. However, people on dolutegravir experienced fewer side effects than those taking efavirenz. We also saw very little treatment failure, and in most cases, even those individuals who had a high viral load subsequently had an undetectable viral load after adherence counselling to take their ART regimen as prescribed.”
According to the World Health Organization, initial studies had highlighted a possible link between DTG and neural tube defects in infants born to women using the drug at the time of conception. Neural tube defects in infants exposed to DTG at the time of conception or early in pregnancy have been observed in an observational study in Botswana, but this safety signal has not shown up in reviews of cohorts in other countries. Based on new evidence assessing benefits and risks, the WHO recommends the use of the HIV drug DTG as the preferred first-line and second-line treatment for all populations, including pregnant women and those of childbearing potential. The WHO also highlighted the important of education around DTG to assist women to make an informed choice. Insomnia and weight gain are the most common undesired side effects of DTG and it is advised that the pill is taken in the morning.
General practitioner Dr Sindi van Zyl spoke on the importance of PrEP (pre-exposure prophylaxis), which is an HIV prevention strategy to afford HIV negative people the opportunity to take daily medications to prevent them from becoming infected with HIV if they are exposed to the virus.
According to Paul Miller, CEO at Cipla South Africa, Cipla has been committed to the cause of HIV/AIDS for over two decades ensuring that ‘None shall be denied’ in terms of access to affordable medication. “Over the past two decades, Cipla has helped to revolutionise HIV therapy. In 2001, we introduced the world’s first ever recommended 3-in-1 fixed dose combination to fight AIDS. This amazing breakthrough overcame many challenges. It ensured adherence and helped to reduce the pill burden,” says Miller.
The 3-in1 fixed dose combination was made available at less than $1 per day compared to over $12 000 per patient per year prevailing in most countries throughout the world. It contributed to lift the death sentence from millions across the developing world, changing HIV to a chronic condition and they can lead a near normal life.
Other speakers at the CIPLA event included cardiologist and medical tech entrepreneur Dr Riaz Motara; Dr Moeketsi Mathe, a medical doctor focusing on HIV; Dr Mookho Malahleha, co-principal investigator of HIV vaccine trials; South Africa’s leading expert on social media law Emma Sadleir; and Prof Ameena Goga of the Centre for Maternal, Foetal, Newborn and Child Health Care Strategies at the University of Pretoria.