When will WHO update this information in our guidelines?
WHO is committed to providing rapid updates when new scientific and programmatic information becomes available, to better guide HIV treatment for people living with HIV and country programmes. In July 2017, WHO launched a series of guidelines and tools that outline approaches to transitioning from EFV-based first-line regimens to DTG-based first-line regimens. They also outline the considerations for making that transition, including registration of the drug, stocks, training of clinicians, monitoring for toxicity, and information about country rates of NNRTI resistance (see Tables 1 and 2 below).
In the fourth quarter of 2017, WHO will update the technical document “Transition to new ARVS for HIV programmes” to include new clinical and programmatic evidence regarding the safety and efficacy of DTG in first-line HIV treatment and the emerging use of DTG in second-line treatment. In 2018, WHO will undertake a full review to update the 2016 WHO consolidated ARV guidelines.
Please review the relevant WHO guidelines and guidance tools to support DTG transition:
Transition to new antiretroviral drugs in HIV programmes: clinical and programmatic considerations
Transition to new antiretrovirals in HIV programmes
Guidelines on the public health response to pretreatment HIV drug resistance
Guidelines for managing advanced HIV disease and rapid initiation of antiretroviral therapy
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection
Table 1. Summary of programmatic considerations on transitioning to DTG and EFV400 in low- and middle-income countries
Optimization criteria DTG-containing regimens EFV400-containing regimens Comments
Efficacy High efficacy, especially in the context of resistance to NNRTIs; efficacy data on HIV-associated TB still pending Emerging data suggest adequate therapeutic levels in pregnancy and TB treatment with rifampicin but concerns on efficacy with rising resistance to NNRTIs in low- and middle-income countries Favours DTG
Safety No long-term safety data among people living with HIV. Limited safety data for young children, pregnancy and HIV-associated TB EFV has been used for decades in low- and middle-income countries and is safe for pregnant women and people with TB; lower doses are better tolerated Currently favours EFV400; however, data on safety of DTG in pregnancy and children growing
Simplification Generic single formulation already available, but fixed-dose combinations expected in 2018; dose adjustment needed for TB co-treatment (twice-daily dose) Generic fixed-dose combinations already available; no dose adjustment needed and maintenance of once-daily dose Favours equally, as fixed-dose combination available for both
Harmonization Strategically preferred choice in the long term Limitations for use in all populations (not applicable to children) Favours DTG
Cost Cheaper than EFV600 but higher potential for further cost reduction (strong generic competition expected) Cheaper than EFV600 but less potential for further cost reduction Favours DTG
Table 2 : Examples of scenarios and considerations for transition to new first-line ARV drugs
Potential country scenario Factors that can prompt faster uptake of new ARVs Country-level actions needed to support introduction of new ARVs
Rapid transition to DTG-based first-line ART Countries with pretreatment HIVDR to NNRTIs ≥10% Country has a policy for introducing DTG
Availability of low-cost generic DTG in a fixed-dose combination Supply chain system prepared for the transition
DTG registered in the country
Phased transition to DTG-based first-line ART Countries with pretreatment HIVDR to NNRTIs <10% Country has a policy on introducing DTG
Low availability of low-cost generic DTG in a fixed-dose combination Supply chain system not well prepared for the transition
High burden of HIV-associated TB requiring rifampicin treatment DTG registered in the country
High burden of pregnant women living with HIV
Transition to DTG-based first-line ART could be delayed Countries with pretreatment HIVDR to NNRTIs <10% Country has no policy on introducing DTG
No availability of low-cost generic DTG in a fixed-dose combination Supply chain system not prepared for the transition
DTG not registered in the country
Transition to EFV400-based first-line ART can be considered Countries with pretreatment HIVDR to NNRTIs <10% Country has no policy on introducing DTG
Availability of low-cost generic EFV400 in a fixed-dose combination Supply chain system prepared for the transition
No availability of low-cost generic DTG in a fixed-dose combination EFV400 in a fixed-dose combination registered in the country
DTG not registered in the country
Transition to EFV400-based first-line ART should be reconsidered Countries with pretreatment HIVDR to NNRTIs ≥10%
- Other programmatic factors (such as patient and clinician readiness to accept the new drugs; viral load suppression rates among those on ART; ability to monitor drug toxicity; and supervision and monitoring of programme quality) should also be considered.