Medicines regulator’s safety worries delay rollout of new HIV drug
Sahpra will relax requirement that prescribers and female patients sign a form to access TLD
The health department’s plans to switch HIV patients to a cheaper pill containing dolutegravir have hit yet another stumbling block after measures instituted by the medicines regulator to warn women of its potential risks have unexpectedly scared them off.
More than six months after the government awarded supply contracts to pharmaceutical manufacturers, a mere 35,000 patients are on the new pills. The extremely low numbers have prompted the health department to ask the SA Health Products Regulatory Authority (Sahpra) to review its requirements, which are to be relaxed from this week.