FDA gives approval to new HIV treatment regimens

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The US Food and Drug Administration (FDA) has approved expanded indication of Isentress to include HIV-1 exposed full-term neonates, from birth to 4 weeks of age. Healio reports it has announced that Isentress (raltegravir, Merck) is now indicated in combination with other antivirals for treating HIV-1 in paediatric patients weighing at least 2 kg.

A phase 1 safety and pharmacokinetics study of raltegravir for oral suspension was conducted in 42 full-term neonates (52% male) at high risk of acquiring HIV-1 infection. The patients were divided into two cohorts, with cohort 1 (16 neonates) receiving 2 single doses of raltegravir for oral suspension, including the first within 48 hours of birth and the second at days 7 to 10 of age.

Cohort 2 (28 neonates) received daily dosing of raltegravir for oral suspension for 6 weeks, including 1.5 mg/kg once daily starting within 48 hours of birth through day 7; 3 mg/kg twice daily on days 8 to 28 of age; and 6 mg mg/kg twice daily on days 29 to 42 of age. Six patients in cohort 1 and all patients in cohort 2 were unexposed to raltergravir in utero.

Nucleic acid test at birth, week 6 and week 24 was used to measure HIV-1 status, and all patients were HIV-1 negative at the completion of the study. No drug-related clinical adverse reactions and three drug-related laboratory adverse reactions were reported, with the safety profile in neonates generally similar to that observed in older patients treated with raltegravir, the FDA reported.

The FDA noted that raltegravir is not recommended in pre-term neonates or in paediatric patients weighing less than 2 kg. The agency also noted that if the mother has taken Isentress or Isentress HD between 2 to 24 hours prior to delivery, the first dose for the neonate should be given between 24 and 48 hours after birth.


And for the first time, the FDA has approved an HIV treatment regimen that contains only two antiretrovirals (ARVs), instead of the standard three or more drugs. Juluca (dolutegravir/rilpivirine), a combination of drugs from ViiV Healthcare and Janssen, is approved as a new option for people with HIV who have been virally suppressed on their current ARV regimen for at least six months. Additionally, individuals considering Juluca should have no history of HIV treatment failure and no known viral mutations associated with resistance to either of the drugs in the regimen.

This regimen is an option for those looking to avoid nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). ViiV’s dolutegravir, which is sold individually under the brand name Tivicay, is an integrase inhibitor. Janssen’s rilpivirine, sold under the brand name Edurant, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). Tivicay in particular is prized because it is associated with a low rate of emerging drug resistance – otherwise known as a high barrier to resistance – among those treated with the ARV.

The FDA approval is based on two identical clinical trials, SWORD 1 and 2, which included 1,024 people with HIV who were initially on successful ARV treatment. Findings from these studies were reported in February at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle. The participants were randomised to stay on their current regimen or switch to the components of Juluca. Those who took the two-drug regimen had the same rate of viral suppression after 48 weeks (95%) as those who stayed on their initial regimen.

At week 48, 0.6% of those in the two-drug group had a viral load greater than 50, indicating virologic failure, compared with 1.2% of those who stayed on their original regimen.

The most common adverse health events among those taking Juluca were diarrhoea and headache, each reported by 2% of the participants.

Fewer drugs in an HIV treatment regimen should spell less toxicity, at least in theory. Future research should indicate whether the two-drug regimen does indeed confer a long-term safety advantage over regimens including three or more ARVs, in particular with regard to bone and kidney health.

Healio material
Poz material

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