LONDON, September 23, 2015 /PRNewswire/ --
ViiV Healthcare today announced 24-week data from the Phase IIIb/IV STRIIVING study, an open-label study evaluating the efficacy, safety and tolerability of switching from an antiretroviral therapy (ART) to the once-daily, fixed-dose dolutegravir-based regimen, Triumeq(R) (abacavir/dolutegravir/lamivudine) in virologically suppressed adults with HIV-1 (n=274).[1] The study included (n= 277) adults who remained on their existing ART to 24 weeks. STRIIVING met its primary endpoint, demonstrating that viral suppression was non-inferior for patients switching to abacavir/dolutegravir/lamivudine (HIV RNA <50 copies/mL in intention to treat efficacy (ITTe, primary endpoint; n=551): 85% (abacavir/dolutegravir/lamivudine) vs. 88% (existing ART) [adjusted difference -3.4%; 95% CI: -9.1, 2.3], per protocol (PP; n=435): 93% vs. 93% [adjusted difference -0.3%; 95% CI: -4.9, 4.4]).[1] No patients had protocol defined virologic failure (confirmed plasma HIV-1 RNA greater than or equal to400 copies/mL) and therefore no patients were evaluated for treatment-emergent resistance in either arm (ITTe).[1]
Furthermore, statistically, the treatment satisfaction score improved significantly more for those patients switching to once-daily abacavir/dolutegravir/lamivudine from their established regimen, as assessed by the HIV Treatment Satisfaction Questionnaire (adjusted difference 2.4, 95% CI: 1.3, 3.5; p<0.001).[1]
"For clinicians, choosing among antiretroviral therapies now involves balancing efficacy with factors such as tolerability, dosing, ability to use with other medications, and resistance profile. These data support the use of once-daily abacavir/dolutegravir/lamivudine as a treatment option in the switch setting for appropriate patients," said John Pottage, MD, Chief Scientific and Medical Officer, ViiV Healthcare.
The STRIIVING study recruited patients switching from a broad range of protease inhibitor (PI; n=234), integrase strand transfer inhibitor (INSTI; n=146) and non-nucleoside reverse transcriptase inhibitor (NNRTI; n=171)-based regimens, with the aim of reflecting a common clinical situation.[1]
Patients switching to abacavir/dolutegravir/lamivudine reported more adverse events (AEs) leading to withdrawal compared with those who continued on their established regimen (ITTe: 4% vs. 0%).[1] The majority of these AEs were Grade I & 2.[1] The most common AEs (greater than or equal to 5%) reported in patients switched to the abacavir/dolutegravir/lamivudine arm included cough (5%), diarrhoea (7%), fatigue (7%), headache (5%), nausea (10%) and upper respiratory tract infection (7%).[1] The AE profile observed with abacavir/dolutegravir/lamivudine in the study is in line with previous studies with dolutegravir-based regimens.[2],[3],[4],[5],[6]
STRIIVING study design
STRIIVING is a Phase IIIb/IV randomised, open-label, multicentre, North American study to evaluate the efficacy, safety and tolerability of switching from an ART regimen to once-daily, fixed-dose abacavir/dolutegravir/lamivudine in virologically-suppressed (HIV-1 RNA <50 copies/mL) adults with HIV-1. Participants were randomised 1:1 to switch to abacavir/dolutegravir/lamivudine (n=274) or continue on their current ART (n=277) for 24 weeks. The total number of patients in the study was 551.[1]
Important Safety Information (ISI) for Triumeq(R) (abacavir, dolutegravir and lamivudine) tablets
The following ISI is based on the Highlights section of the Prescribing Information for Triumeq. Please consult the full Prescribing Information for all the labelled safety information for Triumeq.
BOXED WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVEREHEPATOMEGALY, AND EXACERBATIONS OF HEPATITIS B See full Prescribing Information for complete boxed warning.
- Serious and sometimes fatal hypersensitivity reactions have been associated with
abacavir-containing products.
- Hypersensitivity to abacavir is a multi-organ clinical syndrome.
- Patients who carry the HLA-B*5701 allele are at high risk for experiencing a
hypersensitivity reaction to abacavir.
- Discontinue Triumeq as soon as a hypersensitivity reaction is suspected. Regardless of
HLA-B*5701 status, permanently discontinue Triumeq if hypersensitivity cannot be ruled
out, even when other diagnoses are possible.
- Following a hypersensitivity reaction to abacavir, NEVER restart Triumeq or any other
abacavir-containing product.
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have
been reported with the use of nucleoside analogues.
- Severe acute exacerbations of hepatitis B have been reported in patients who are
co-infected with Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV-1) and
have discontinued lamivudine, a component of Triumeq. Monitor hepatic function closely
in these patients and, if appropriate, initiate anti-hepatitis B treatment.
CONTRAINDICATIONS
- Presence of HLA-B*5701 allele.
- Previous hypersensitivity reaction to abacavir, dolutegravir or lamivudine.
- Co-administration with dofetilide.
- Moderate or severe hepatic impairment.
WARNINGS AND PRECAUTIONS
Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of Triumeq. Appropriate laboratory testing prior to initiating therapy and monitoring for hepatotoxicity during therapy with Triumeq is recommended in patients with underlying hepatic disease such as hepatitis B or C.
- Hepatic decompensation, some fatal, has occurred in HIV-1/Hepatitis C Virus (HCV)
co-infected patients receiving combination antiretroviral therapy and interferon alfa
with or without ribavirin. Discontinue Triumeq as medically appropriate and consider
dose reduction or discontinuation of interferon alfa, ribavirin, or both.
- Immune reconstitution syndrome and redistribution/accumulation of body fat have been
reported in patients treated with combination antiretroviral therapy.
- Administration of Triumeq is not recommended in patients receiving other products
containing abacavir or lamivudine.
ADVERSE REACTIONS The most commonly reported (greater than or equal to2%) adverse reactions of at least moderate intensity in treatment-naive adult subjects receiving Triumeq were insomnia (3%), headache (2%), and fatigue (2%).
DRUG INTERACTIONS Co-administration of Triumeq with other drugs can alter the concentration of other drugs and other drugs may alter the concentrations of Triumeq. The potential drug-drug interactions must be considered prior to and during therapy.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Triumeq should be used during pregnancy only if the potential benefit
justifies the potential risk.
- Nursing mothers: Breastfeeding is not recommended due to the potential for HIV
transmission.
- Triumeq is not recommended in patients with creatinine clearance less than 50 mL per
min.
If a dose reduction of abacavir, a component of Triumeq, is required for patients with mild hepatic impairment, then the individual components should be used.
About Triumeq(R)
Triumeq is a once-daily dolutegravir-based regimen, containing the integrase strand transfer inhibitor (INSTI) dolutegravir and the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.
(CONTINUA)
