Product Profiles: HIV - Growing number of FDCs further commoditizes the HIV market

Introduction

Gilead’s/Bristol-Myers Squibb’s Atripla was the first marketed cross-class fixed dose combination (FDC), an antiretroviral drug class in which drugs from different drug classes are being combined into a single pill to be taken once daily. Today, Atripla is widely accepted as the gold standard in HIV in the US and the five major EU markets (France, Germany, Italy, Spain, and the UK).

Features and benefits

• In-depth discussion of key marketed and pipeline antiretrovirals
• Extensive analysis of clinical trial data and assessment of clinical and commercial attractiveness for pipeline and marketed HIV drugs
• Analysis of life-cycle management and marketing strategies
• Discussion of future strategic opportunities to achieve success in a crowded HIV market

Highlights

As a result of new FDCs reaching the market, HIV treatment, particularly in first line, will move away from the current "Atripla-for-all-approach" towards a more individualized approach. Tolerability and a drug’s resistance profile will emerge as key differentiation factors between the various available regimens.

The first-to-market cross-class fixed-dose combination (FDC) Atripla is widely accepted as the gold standard in HIV in the US and the five major EU markets (France, Germany, Italy, Spain, and the UK).

Apart from continuing efforts to assess pipeline and marketed drugs in cross-class FDCs and nuc-sparing regimens, there is also an increasing focus on certain subsets of patients, antiretrovirals als pre-exposure prophylaxis (PrEP) and intensification therapies to target residual viral reservoirs.

Table Of Contents

OVERVIEW
Catalyst
Summary

 EXECUTIVE SUMMARY

 MARKET DEFINITION AND OVERVIEW
Product overview
New product launches

 MARKETED PRODUCT PROFILES
Truvada (tenofovir disoproxil fumarate/emtricitabine; Gilead Sciences)
Drug profile
Development overview
Recent/ongoing key clinical trials
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Atripla (tenofovir disoproxil/emtricitabine/efavirenz; Gilead Sciences/Bristol-Myers Squibb)
Drug profile
Development overview
Recent/ongoing key clinical trials
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Reyataz (atazanavir; Bristol-Myers Squibb)
Drug profile
Development overview
Recent/ongoing key clinical trials
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Prezista (darunavir; Tibotec Pharmaceuticals/Johnson & Johnson)
Drug profile
Development overview
Recent/ongoing key clinical trials
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Isentress (raltegravir; Merck & Co.)
Drug profile
Development overview
Ongoing/recent key clinical trials
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Complera (tenofovir disoproxil fumarate/emtricitabine/rilpivirine; Gilead Sciences/Tibotec Pharmaceuticals/Johnson & Johnson)
Drug profile
Development overview
Ongoing key clinical trials
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Other marketed drugs for HIV
Edurant (rilpivirine/TMC278; Tibotec Pharmaceuticals/Johnson & Johnson)
Combivir (lamivudine/zidovudine; ViiV Healthcare)
Epzicom/Kivexa (abacavir/lamivudine; ViiV Healthcare)
Sustiva (efavirenz; Bristol-Myers Squibb)
Kaletra (lopinavir/ritonavir; Abbott Laboratories)
Viramune (nevirapine; Boehringer Ingelheim)
Intelence (etravirine; Tibotec/Johnson & Johnson)
Selzentry/Celsentri (maraviroc; ViiV Healthcare)

 PIPELINE PRODUCT PROFILES
Quad pill (tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat; Gilead Sciences)
Drug profile
Development overview
Ongoing clinical trials
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
572-Trii (abacavir/lamivudine/S/GSK-1349572; Shionogi & Co./ViiV Healthcare)
Drug profile
Development overview
Ongoing clinical trials
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Dolutegravir (S/GSK-1349572; Shionogi & Co./ViiV Healthcare)
Drug profile
Development overview
Ongoing clinical trials
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Cobicistat (GS-9350; Gilead Sciences)
Drug profile
Development overview
Ongoing clinical trials
SWOT analysis
Satisfaction of unmet needs
Clinical and commercial attractiveness
Other drugs in development for HIV
Elvitegravir (GS-9137; Gilead Sciences)
Lersivirine (UK-453061; ViiV Healthcare)
BMS-663068 (Bristol-Myers Squibb)
GSK-2248761 (ViiV Healthcare)

 BIBLIOGRAPHY
Journal papers
Websites

 APPENDIX
Contributing experts
Conferences attended
Report methodology

LIST OF TABLES

Table: Key marketed and pipeline products for HIV, 2011
Table: Patent expiry dates for key marketed brands in HIV in the US and Japan, 2011
Table: Patent expiry dates for key marketed brands in HIV in the five major EU markets, 2011
Table: Estimated launch dates for key late-stage pipeline products and marketed brands in the seven major markets, 2011–20
Table: Truvada – drug profile, 2011
Table: Overview of pivotal trial data for Truvada, 2011
Table: Datamonitor drug assessment summary of Truvada (tenofovir disoproxil fumarate/emtricitabine; Gilead Sciences) for HIV, 2011
Table: Atripla – drug profile, 2011
Table: Overview of pivotal trial data for Atripla, 2011
Table: Datamonitor drug assessment summary of Atripla (tenofovir disoproxil fumarate/emtricitabine/efavirenz; Gilead Sciences/Bristol-Myers Squibb) for HIV, 2011
Table: Reyataz – drug profile, 2011
Table: Overview of pivotal trial data for Reyataz, 2011
Table: Summary of the ARIES trial for boosted versus unboosted atazanavir ( Reyataz; Bristol-Myers Squibb), 2011
Table: Overview of the SPARTAN trial of atazanavir with raltegravir versus atazanavir with tenofovir disoproxil fumarate/emtricitabine in treatment-naïve patients, 2011
Table: Overview of study A4001078 for ritonavir-boosted atazanavir and maraviroc in treatment-naïve patients , 2011
Table: Datamonitor drug assessment summary of Reyataz (atazanavir; Bristol-Myers Squibb) for HIV, 2011
Table: Prezista – drug profile, 2011
Table: Overview of pivotal trial data for Prezista ( darunavir ), 2011
Table: Overview of the ODIN trial for once-daily versus twice-daily Prezista in selected treatment-experienced HIV-1 infected adults , 2011
Table: Overview of the open-label Phase IIIb trial for once-daily cobicistat-boosted darunavir (Prezista) in treatment-naïve and selected treatment-experienced HIV-1 infected adults , 2011
Table: Overview of the multicenter Phase III trial A4001095 of darunavir and maraviroc in treatment-naïve HIV-1 infected adults, 2011
Table: Datamonitor drug assessment summary of Prezista (darunavir; Tibotec/Johnson & Johnson) for HIV, 2011
Table: Isentress – drug profile, 2011
Table: Overview of pivotal trial data for raltegravir ( Isentress), 2011
Table: Phase III QDMRK study comparing raltegravir once-daily versus twice-daily dosing in treatment-naïve HIV-1 infected adults, 2011
Table: Overview of key switch-over trials involving Isentress 2011
Table: Phase III study comparing raltegravir and lopinavir/ritonavir to a regimen of lopinavir/ritonavir and tenofovir disoproxil fumarate/emtricitabine in treatment-naïve HIV-1 infected adults, 2011
Table: Phase II study comparing raltegravir and lopinavir/ritonavir to Atripla in treatment-naïve HIV-1 infected adults, 2011
Table: Overview of the SPARTAN trial of atazanavir and raltegravir versus atazanavir/ritonavir and tenofovir/emtricitabine in treatment-naïve patients, 2011
Table: ACTG A5262: non-randomized, single-arm pilot study of raltegravir and boosted darunavir in treatment-naïve HIV-1 infected patients , 2011
Table: Overview of a Phase III trial of Prezista and Isentress versus Prezista and Truvada in treatment-naive HIV-1 infected adults , 2011
Table: Overview of a Phase IV trial of raltegravir with darunavir versus darunavir and tenofovir disoproxil fumarate/emtricitabine in treatment-naive HIV-1 infected adults , 2011
Table: Datamonitor drug assessment summary of Isentress (raltegravir; Merck & Co.) for HIV, 2011
Table: Complera (emtricitabine/tenofovir disoproxil fumarate/rilpivirine; Gilead Sciences/Tibotec Pharmaceuticals/Johnson & Johnson) – drug profile, 2011
Table: Clinical trial summary for Edurant and Complera, 2011
Table: A Phase III switch-over study from protease inhibitor (PI)- based regimens to Complera, 2011
Table: A Phase IIb switch-over study from Atripla to Truvada/rilpivirine, 2011
Table: A Phase III head-to-head trial of Complera versus Atripla
Table: Datamonitor drug assessment summary of Complera (tenofovir disoproxil fumarate/rilpivirine; Gilead Sciences/Tibotec/Johnson & Johnson) for HIV, 2011
Table: Quad pill (tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat; Gilead Sciences) – drug profile, 2011
Table: Summary of the key Phase II and Phase III clinical trials for the Quad pill in treatment of HIV-1, 2011
Table: Ability of the Quad pill to meet unmet needs, 2011
Table: Datamonitor drug assessment summary of the Quad pill (tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat; Gilead Sciences) for HIV, 2011
Table: 572-Trii (Shionogi & Co./ViiV Healthcare)– drug profile, 2011
Table: The randomized, double-blind Phase III SINGLE trial for 572-Trii versus Atripla in treatment-naïve HIV-1 infected individuals, 2011
Table: Ability of 572-Trii to meet unmet needs, 2011
Table: Datamonitor drug assessment summary of the 572-Trii (abacavir/lamivudine/S/GSK-1349572; Shionogi & Co./ViiV Healthcare) for HIV, 2011
Table: Dolutegravir (Shionogi & Co./ViiV Healthcare) – drug profile, 2011
Table: Clinical trial summary dolutegravir, 2011
Table: A Phase III study of dolutegravir versus raltegravir in treatment-naïve HIV-1 infected adults, 2011
Table: A Phase III study of dolutegravir versus raltegravir in treatment-experienced HIV-1 infected adults (SAILING trial), 2011
Table: A Phase III study of dolutegravir versus raltegravir in treatment-experienced HIV-1 infected adults with previous failure on an integrase inhibitor-containing regimen (VIKING III), 2011
Table: Ability of dolutegravir to meet unmet needs, 2011
Table: Datamonitor drug assessment summary of dolutegravir (S/GSK-1349572; Shionogi & Co./ViiV Healthcare) for HIV, 2011
Table: Cobicistat drug profile, 2011
Table: Summary of key Phase II clinical trial for cobicistat as a standalone boosting agent for atazanavir (Reyataz; Bristol-Myers Squibb) head-to-head versus ritonavir (Norvir; Abbott Laboratories), 2011
Table: A Phase III study of cobicistat versus ritonavir as boosting agent for atazanavir in treatment-naïve HIV-1 infected individuals, 2011
Table: A Phase IIIb open-label single-arm study of cobicistat plus darunavir plus two fully active NRTIs in treatment-naïve and –experienced HIV-1 infected individuals without darunavir-associated mutations, 2011
Table: Ability of cobicistat to meet unmet needs, 2011

 LIST OF FIGURES

Figure: Truvada sales across the seven major markets and the rest of world markets, by geography, 2011
Figure: Truvada SWOT analysis in HIV, 2011
Figure: Datamonitor drug assessment summary of Truvada (tenofovir disoproxil fumarate/emtricitabine; Gilead Sciences) for HIV, 2011
Figure: Atripla sales across the seven major markets and the rest of world region, by geography, 2011
Figure: Atripla SWOT analysis in HIV, 2011
Figure: Datamonitor drug assessment summary of Atripla (tenofovir disoproxil fumarate/emtricitabine/efavirenz; Gilead Sciences/Bristol-Myers Squibb) for HIV, 2011
Figure: Reyataz sales across the seven major markets and the rest of world region, by geography, 2011
Figure: Reyataz SWOT analysis in HIV, 2011
Figure: Datamonitor drug assessment summary of Reyataz (atazanavir; Bristol-Myers Squibb) for HIV, 2011
Figure: Prezista sales across the seven major markets and the rest of world region, by geography, 2011
Figure: Prezista SWOT analysis in HIV, 2011
Figure: Datamonitor drug assessment summary of Prezista (darunavir; Tibotec/Johnson & Johnson) for HIV, 2011
Figure: Isentress sales across the seven major markets and the rest of world region, by geography, 2011
Figure: Isentress SWOT analysis in HIV, 2011
Figure: Datamonitor drug assessment summary of Isentress (raltegravir; Merck & Co.) for HIV, 2011
Figure: Phase III clinical trial for rilpivirine (Edurant), design and results, 2011
Figure: Complera SWOT analysis in HIV, 2011
Figure: Datamonitor drug assessment summary of Complera (tenofovir disoproxil fumarate/rilpivirine; Gilead Sciences/Tibotec/Johnson & Johnson) for HIV, 2011
Figure: Phase III trial of the Quad pill versus Atripla in treatment-naïve HIV-1 infected adults, 2011
Figure: Phase III trial of the Quad pill versus ritonavir-boosted atazanavir plus tenofovir disoproxil fumarate in treatment-naïve HIV-1 infected adults, 2011
Figure: Phase II trial of the Quad pill versus Atripla in treatment-naïve HIV-1 infected adults, 2011
Figure: SWOT analysis for the Quad pill, 2011
Figure: Datamonitor drug assessment summary of the Quad pill (tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat; Gilead Sciences) for HIV, 2011
Figure: SWOT analysis for 572-Trii, 2011
Figure: Datamonitor drug assessment summary of the 572-Trii (abacavir/lamivudine/S/GSK-1349572; Shionogi & Co./ViiV Healthcare) for HIV, 2011
Figure: SWOT analysis for dolutegravir, 2011
Figure: Datamonitor drug assessment summary of dolutegravir (S/GSK-1349572; Shionogi & Co./ViiV Healthcare) for HIV, 2011
Figure: Phase II trial of cobicistat versus ritonavir as a boosting agent for atazanavir in treatment-naïve HIV-1 infected adults, 2011
Figure: SWOT analysis for cobicistat as a standalone boosting agent in HIV-1 treatment, 2011