Regulator concerns that GlaxoSmithKline’s HIV drug dolutegravir may be linked to birth defects could severely limit women’s access to the medicine and undermine their rights to be involved in decisions about their health, the Southern African HIV Clinicians Society warned on Wednesday. Regulators in Europe and the US flagged safety concerns over dolutegravir on May 18, after a small study in Botswana identified four cases of neural tube defects among 426 women who fell pregnant while taking dolutegravir in combination with other antiretrovirals. The development raises tough questions for the Department of Health, which is planning to switch patients on first line therapy to a three-in-one combination pill containing dolutegravir once generic versions are registered with the South African Health Products Regulatory Authority (Sahpra).

Dolutegravir is to replace efavirenz, as it has fewer side effects and patients are less likely to develop drug resistance. The new fixed dose co...

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