Results from the SPRING-2 study were reported in the January 8, 2013 advanced edition of The Lancet. The 48-week, double-blind study followed people new to treatment who took either the experimental integrase inhibitor dolutegravir or the approved integrase inhibitor raltegravir (Isentress).
A total of 822 people enrolled: half took dolutegravir while the other half took raltegravir. Three out of five people chose Truvada (emtricitabine/tenofovir) while 2 out of five chose Epzicom (abacavir/lamivudine) as their NRTI combination.
Of the study participants, their average CD4 count was 360 and about 28% had high viral loads above 100,000. 85% were men, average age was 36 and most were white. About 1 out of 10 also had hepatitis C.
| SPRING-2 study, virologic results at 48 weeks | |||
| dolutegravir | raltegravir | statistically significant? | |
| CD4 count change | +230 | +230 | no |
| Undetectable (overall) | 88% | 85% | no |
| Undetectable (started <100,000) | 90% | 89% | no |
| Undetectable (started >100,000) | 82% | 75% | no |
| Undetectable by week 8 | 85% | 79% | no |
| Virologic failure | 5% | 8% | no |
| Side effect, nausea | 14% | 13% | no |
| Side effect, headache | 12% | 12% | no |
| Side effect, upper respiratory | 11% | 12% | no |
| Side effect, diarrhea | 11% | 11% | no |
| Serious side effects | 1% | 1% | no |
| Stopped study | 2% | 2% | no |
These results appear to show that dolutegravir offers some benefits over the other two approved integrase inhibitors. First, it’s only taken once a day, compared to the twice-daily dosing of raltegravir (Isentress). Second, it doesn’t need a booster drug as elvitegravir (Stribild) does to continue its potency throughout the day. The drug’s manufacturer, ViiV Healthcare, submitted it in December 2012 to the FDA for review and hopefully approval.
Read the study abstract from The Lancet here.
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